/* MEDDESKTOP: June 2008 before the mod*/ MEDDESKTOP: June 2008

Monday, June 30, 2008

Let Go That Viagra, Pick Up A Watermelon.

The researchers have found that watermelon has found chemical properties that carry Viagra like capabilities, it relax the blood vessels. Citrulline is the culprit ingredient. Following is a part of the press release and follow the link at the end to read the complete article at Texas A&M.

COLLEGE STATION -- A cold slice of watermelon has long been a Fourth of July holiday staple. But according to recent studies, the juicy fruit may be better suited for Valentine’s Day.

That’s because scientists say watermelon has ingredients that deliver Viagra-like effects to the body’s blood vessels and may even increase libido.

“The more we study watermelons, the more we realize just how amazing a fruit it is in providing natural enhancers to the human body,” said Dr. Bhimu Patil, director of Texas A&M’s Fruit and Vegetable Improvement Center in College Station.

“We’ve always known that watermelon is good for you, but the list of its very important healthful benefits grows longer with each study.”

Beneficial ingredients in watermelon and other fruits and vegetables are known as phyto-nutrients, naturally occurring compounds that are bioactive, or able to react with the human body to trigger healthy reactions, Patil said.

In watermelons, these include lycopene, beta carotene and the rising star among its phyto-nutrients – citrulline – whose beneficial functions are now being unraveled. Among them is the ability to relax blood vessels, much like Viagra does.

Scientists know that when watermelon is consumed, citrulline is converted to arginine through certain enzymes. Arginine is an amino acid that works wonders on the heart and circulation system and maintains a good immune system, Patil said.

“The citrulline-arginine relationship helps heart health, the immune system and may prove to be very helpful for those who suffer from obesity and type 2 diabetes,” said Patil. “Arginine boosts nitric oxide, which relaxes blood vessels, the same basic effect that Viagra has, to treat erectile dysfunction and maybe even prevent it.”

While there are many psychological and physiological problems that can cause impotence, extra nitric oxide could help those who need increased blood flow, which would also help treat angina, high blood pressure and other cardiovascular problems.

“Watermelon may not be as organ specific as Viagra,” Patil said, “but it’s a great way to relax blood vessels without any drug side-effects.”

The benefits of watermelon don’t end there, he said. Arginine also helps the urea cycle by removing ammonia and other toxic compounds from our bodies.

AGNEWS

Filling Up Wrinkles For Beauty! What You Should Know.

In the quest for youth—or at least a more youthful appearance—women and men are seeking treatments to minimize laugh lines, crow's feet, and forehead furrows. A popular treatment involves injecting cosmetic wrinkle fillers into the face.

Injectable cosmetic wrinkle fillers are soft tissue fillers approved as medical devices by the Food and Drug Administration (FDA). These devices are injected into the skin to help fill in facial wrinkles, restoring a smoother appearance. Most of these wrinkle fillers are temporary because they are eventually absorbed by the body.

Some people may need more than one injection to achieve the wrinkle-smoothing effect. The effect lasts for about six months or longer.

Successful results depend on

  • health of the skin
  • skill of the doctor
  • type of filler used

Uses

FDA has approved absorbable injectable cosmetic wrinkle fillers for correcting soft tissue contour defects, such as moderate and severe wrinkles and folds. Some absorbable fillers are approved for restoring or correcting the signs of facial fat loss in people with human immunodeficiency virus (HIV).

The only non-absorbable FDA-approved injectable cosmetic wrinkle filler is for correcting facial tissue around the mouth.

FDA-approved cosmetic wrinkle fillers should not be used for

  • plumping the lips (lip augmentation)
  • increasing breast size (breast augmentation)
  • implanting into bone, tendon, ligament, or muscle
  • implanting into blood vessels

Filler Materials

Wrinkle fillers are made of various types of materials, and some include a combination of products. Some products also contain lidocaine, which numbs the skin at the injection site.

The materials used in injectable cosmetic wrinkle fillers include

Temporary (absorbable) fillers

  • Collagen injections are made of highly purified cow or human collagen. Collagen is a natural protein that is a major component of skin and other tissues in the body.
  • Hyaluronic acid gel is a protective lubricating gel, produced naturally by the body, that binds with water to plump the skin.
  • Calcium hydroxylapatite is a mineral that is a major component of bone. Calcium hydroxylapatite is a well-matched (biocompatible) material that dissolves in the body (biodegradable) and is implanted in the form of a gel.
  • Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic material from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches and bone screws.

Permanent (non-absorbable) filler

  • Polymethylmethacrylate beads (PMMA microspheres) are tiny round, smooth plastic particles that have been tested to be biocompatible. They are not absorbed by the body.

Risks

Getting injected with cosmetic wrinkle fillers is an elective procedure. As with any medical procedure, it poses risks.

Possible side effects include

  • infection
  • bruising
  • redness
  • swelling
  • pain
  • tenderness
  • itching and rash
  • raised bumps of skin (nodules or granulomas) that may need to be surgically removed
  • death of skin, which may cause disfiguration, if the cosmetic wrinkle filler is injected and blocks a blood vessel
  • sore (abscess) at the injection site
  • wrinkle filler that breaks through the skin
  • open or draining wounds
  • blurred vision and flu-like symptoms
  • increased allergic reaction that may lead to a severe allergic reaction (anaphylactic shock) that requires emergency medical help. (Your doctor may request a pre-treatment allergy test to determine if you are allergic to the filler.)

Most side effects occur shortly after injection and go away within seven days. In some cases, side effects may emerge weeks, months, or years later. A non-absorbable filler may cause long-term side effects.

You should not use cosmetic wrinkle fillers if any of the following applies to you:

  • severe allergies marked by a history of anaphylactic shock
  • allergy to cow collagen or eggs
  • allergy to lidocaine
  • inflamed or infected skin
  • prone to form excessive scarring (keloid) or thick scarring (hypertrophic scars)
  • bleeding disorder
  • active inflammatory condition (cysts, pimples, rashes or hives) or infection; you should postpone treatment until the condition is controlled.

Tips for Consumers

Before deciding to get injected with a cosmetic wrinkle filler:

  • Be aware that the safety of these products is unknown for use in pregnant or breastfeeding women or in patients under 18 years of age.
  • Be aware that the safety is unknown when these products are used with Botox or other wrinkle therapies.
  • Be aware that the safety of these fillers has only been studied when used in the face.
  • Know the type of product that will be injected and all of its possible side effects.
  • Discuss fillers with a doctor who can refer you to a specialist in the fields of dermatology and aesthetic plastic surgery.
  • Select a doctor who is trained to do the procedure. (You may want to contact the American Academy of Dermatology at www.aad.org or the American Society for Aesthetic Plastic Surgery at www.surgery.org.)
  • Have realistic expectations about the benefits you want to achieve and discuss them with your doctor.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

horizontal rule

What About Botox?

Botox Cosmetic is an injectable drug, but it is not a wrinkle filler. Instead of filling the wrinkle, it keeps muscles from tightening so the wrinkles don’t show as much. FDA has approved Botox Cosmetic only to treat wrinkles between the eyebrows.

For More Information

Get the Facts: Botox
www.fda.gov/womens/getthefacts/botox.html

Adverse Reactions Linked to Botox
www.fda.gov/consumer/updates/botox020808.html

horizontal ruleFor More Information

Medical Device Approvals: Wrinkle Fillers
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/consumer/index.cfm?topic=1038

Laser Facts: Wrinkle Treatment
www.fda.gov/cdrh/consumer/laserfacts.html#2

Your Guide to Reporting Problems to FDA
www.fda.gov/consumer/updates/reporting_guide061008.html

Saturday, June 28, 2008

Sudden Hearing Loss Might Be An Early Sign Of Vulnerability to Stroke

Sudden hearing loss could indicate future stroke
American Heart Association rapid access journal report

Preliminary research culled from a national medical insurance records database in Taiwan suggests that sudden loss of hearing might be an early sign of vulnerability to stroke, foreshadowing an actual cerebrovascular event by as much as two years, according to a study reported in Stroke: Journal of the American Heart Association.

Five-year follow-up data on 1,423 patients hospitalized for an acute episode of sudden sensorineural hearing loss (SSNHL) showed they were more than one-and-a-half times more likely to suffer a stroke than a control group of 5,692 patients who had been hospitalized for an appendectomy.

Because the insurance records may not have contained reliable information, such as correct diagnostic codes or confounding factors, the findings should be considered tentative, said lead investigator Herng-Ching Lin, Ph.D., a professor at Taipei Medical University School of Health Care Administration.

"To the best of our knowledge, no study has investigated the incidence or risk of cerebrovascular diseases developing following the onset of sudden sensorineural hearing loss," Lin said. "But because this is the first time any association has been suggested, and because there were many limitations in the data, the results need to be interpreted cautiously until additional independent studies are performed."

The findings are limited because there is not a clear universal definition for SSNHL in the database that was reviewed. "Secondly, the database did not contain information regarding severity of hearing loss, extent of hearing recovery, tobacco use, body mass index and the medical history of cardiovascular disease and atrial fibrillation – all of which can contribute to stroke risk," Lin explained.

Nonetheless, the researchers recommend that all SSNHL patients undergo a comprehensive neurological exam and blood testing to gauge their risk profile for stroke.

###
Co-authors are Pin-Zhir Chao, M.D. and Hsin-Chien Lee, M.D. Individual author disclosures can be found on the manuscript.

Editor's note: For more information on stroke, visit the American Stroke Association Web site: strokeassociation.org.

Statements and conclusions of study authors that are published in the American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

NR08– 1077 (Stroke/Lin)


Contact: Bridgette McNeill
bridgette.mcneill@heart.org
214-706-1135
American Heart Association

Thursday, June 26, 2008

Ground Beef Products Recalled By The Kroger Co. Due To Possible E. Coli O157:H7 Contamination

The Kroger Co., a Cincinnati, Ohio, retailer is recalling an undetermined amount of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.
The products subject to recall include all varieties and weights of ground beef products bearing a Kroger label sold between May 21 and June 8 at Michigan and Columbus and Toledo, Ohio Kroger retail establishments. These ground beef products also include a sell-by date between "05/21/08" and "06/08/08."
These products were distributed to Kroger stores in Michigan and Columbus and Toledo, Ohio.

Recallr: The Kroger Co. Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination

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Portable Migraine Zapper Tested

Portable device effective in zapping away migraine pain

COLUMBUS, Ohio – A novel electronic device designed to "zap" away migraine pain before it starts has proven to be the next form of relief for those suffering from the debilitating disease, according to a study conducted at The Ohio State University Medical Center.

Results of the study, to be presented Friday (6/27) at the annual American Headache Society meeting in Boston, found that the experimental device is safe and effective in eliminating headaches when administered during the onset of the migraine.

With one in eight Americans suffering from chronic migraines, Dr. Yousef Mohammad, a neurologist and principal investigator of the study at Ohio State's Medical Center, says the study's results are promising given that only 50 to 60 percent of migraine patients respond to traditional migraine drug treatments.

The noninvasive transcranial magnetic stimulator (TMS) device interrupts the aura phase of the migraine, often described as electrical storms in the brain, before they lead to headaches. Migraine sufferers often describe "seeing" showers of shooting stars, zigzagging lines and flashing lights, and experiencing loss of vision, weakness, tingling or confusion, followed by intense throbbing head pain, nausea and vomiting.

Previous studies, conducted at Ohio State, using a heavy and bulky TMS device, reduced headache pain. To expedite treatment at home, a portable hand-held device was developed and tested.

"Stimulation with magnetic pulses from the portable TMS device proved effective for the migraine patients," said Mohammad. "Because of the lack of adverse events in this trial and the established safety of the TMS device, this is a promising treatment for migraines with aura. This sets the stage for future studies in migraines without aura."

The TMS device sends a strong electric current through a metal coil, which creates an intense magnetic field for about one millisecond. This magnetic pulse, when held against a person's head, creates an electric current in the neurons of the brain, interrupting the aura before it results in a throbbing headache.

"The device's pulses are painless and safe," Mohammad said. "Since almost all migraine drugs have some side effects, and patients are prone to addiction from narcotics, or developing headaches from frequent use of over-the-counter medication, the TMS device holds great promise for migraine sufferers."

Of the 164 patients involved in the multi-center, randomized clinical trial receiving TMS treatment, 39 percent were pain free at the two-hour post-treatment point, compared to 22 percent in the group receiving "sham" pulses. There were no differences reported related to adverse reactions between the two groups.

It was previously believed that migraine headaches start with vascular constriction, which results in an aura, followed by vascular dilation that will lead to a throbbing headache. However, in the late 1990's it was suggested that neuronal electrical hyperexcitablility resulted in a throbbing headache. This new understanding of the migraine mechanism assisted in the development of the TMS device.

Contact: Sherri L. Kirk
Sherri.Kirk@osumc.edu
614-293-3737
Ohio State University Medical Center

NeuraLieve, manufacturer of the device located in Sunnyvale, Ca., provided the funding and equipment for the study. Mohammad serves on the company's board of directors.

Wednesday, June 25, 2008

RoomSaring And BedSharing With Your Baby : Bedsharing and bassinets Risks!

Bedsharing and bassinets: 2 new studies assess the risks

Cincinnati, OH, June 25, 2008--Bassinet use in 2006 was nearly double what it was in 1992, and even though more than 45% of infants between the ages of 0-2 months use them, little is known about bassinet safety. In fact, the Consumer Product Safety Commission (CPSC) has guidelines regarding bassinet construction, but there are no government safety standards for bassinets. In 2005, the American Academy of Pediatrics (AAP) revised its recommendations for a safe infant sleep environment, suggesting a separate but nearby sleeping arrangement (i.e. roomsharing without bedsharing). Two studies soon to be published in The Journal of Pediatrics evaluate the frequency of bedsharing and the potential risk factors of bassinet use.

Drs. Jodi Pike and Rachel Moon of Children's National Medical Center in Washington, D.C., used CPSC records from 1990 to 2004 to review the death reports of 53 infants who died suddenly and unexpectedly in bassinets. In 85% of the cases, the researchers found that lack of oxygen was the cause of death. More than half of the infants were found on their stomachs, and other items such as blankets, pillows, and plastic bags were found in 74% of the bassinets. Nine infants died in bassinets that were not functioning correctly, either from misuse or mechanical problems.

In a related study, Dr. Moon and colleagues from Children's National Medical Center, George Washington University, Yale University, and Boston University, reviewed the sleep locations of 708 mothers and their infants. Using the data collected from several Women, Infant, and Children centers (WIC) in 2005, the researchers found that roughly 33% of the mothers and infants were sharing a sleep space. According to the authors, "Approximately half of all sudden and unexpected infant deaths in the United States occur when an infant is sharing a sleep surface with someone else; the factors associated with bedsharing are also associated with SIDS."

Bassinets allow for roomsharing without bedsharing. According to Drs. Pike and Moon, "If parents plan to use a bassinet, they should make sure that it is in good repair and conforms to CPSC guidelines." The CPSC calls for bassinets to have a sturdy bottom with a wide base, smooth surfaces without protruding hardware, legs with locks, and a firm, snuggly fitting mattress. Because 6 of the 53 infants were found with their faces wedged against the side of the bassinet, the authors suggest that a bassinet with sides made of an air permeable material, such as mesh, may be safer. They also emphasize that parents should always lay infants on their backs and never put loose items like blankets or pillows in the bassinet with the baby.

Contact: Brigid Huey
journal.pediatrics@cchmc.org
513-636-7140
Elsevier Health Sciences

Tuesday, June 24, 2008

New antimicrobial wash rapidly kills Salmonella and E. coli O157:H7 on food

New UGA invention effectively kills foodborne pathogens in minutes

University of Georgia researchers have developed an effective technology for reducing contamination of dangerous bacteria on food. The new antimicrobial wash rapidly kills Salmonella and E. coli O157:H7 on foods ranging from fragile lettuce to tomatoes, fruits, poultry products and meats. It is made from inexpensive and readily available ingredients that are recognized as safe by the U.S. Food and Drug Administration.

The new technology, which has commercial application for the produce, poultry, meat and egg processing industries, is available for licensing from the University of Georgia Research Foundation, Inc., which has filed a patent application on the new technology.

The Centers for Disease Control and Prevention estimates that, in the U.S. alone, foodborne pathogens are responsible for 76 million illnesses every year. Of the people affected by those illnesses, 300,000 are hospitalized and more than 5,000 die. These widespread outbreaks of food-borne illnesses are attributed, in part, to the fast-paced distribution of foods across the nation. Recently, raw tomatoes caused an outbreak of salmonellosis that sickened more than 300 people in at least 28 states and Canada.

Currently, a chlorine wash is frequently used in a variety of ways to reduce harmful bacteria levels on vegetables, fruits and poultry, but because of chlorine's sensitivity to food components and extraneous materials released in chlorinated water treatments, many bacteria survive. Chlorine is toxic at high concentrations, may produce off-flavors and undesirable appearance of certain food products, and it can only be used in conjunction with specialized equipment and trained personnel. In addition, chlorine may be harmful to the environment.

"We can't rely on chlorine to eliminate pathogens on foods," said Michael Doyle, one of the new technology's inventors and director of UGA's Center for Food Safety. "This new technology is effective, safe for consumers and food processing plant workers, and does not affect the appearance or quality of the product. It may actually extend the shelf-life of some types of produce."

Doyle is an internationally recognized authority on food safety whose research focuses on developing methods to detect and control food-borne bacterial pathogens at all levels of the food continuum, from the farm to the table. He has served as a scientific advisor to many groups, including the World Health Organization, the Food and Drug Administration, the U.S. Department of Agriculture, the U.S. Department of Defense and the U.S. Environmental Protection Agency.

The new antimicrobial technology, developed by Doyle and Center for Food Safety researcher Tong Zhao, uses a combination of ingredients that kills bacteria within one to five minutes from application. It can be used as a spray and immersion solution, and its concentration can be adjusted for treatment of fragile foods such as leafy produce, more robust foods such as poultry, or food preparation equipment and food transportation vehicles.

"The effectiveness, easy storage and application, and low cost of this novel antibacterial make it applicable not only at food processing facilities, but also at points-of-sale and at home, restaurants and military bases. The development of this technology is timely, given the recent, sequential outbreaks of foodborne pathogens," said Gennaro Gama, UGARF technology manager in charge of licensing this technology.

Contact: Kim Osborne
kosborne@uga.edu
706-583-0913
University of Georgia

Recallr: Burrata Cheese Recall Expanded By Fresca Italia, Inc.

Recallr: Burrata Cheese Recall Expanded By Fresca Italia, Inc.

June 23, 2008 -- Fresca Italia of Brisbane, CA is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

This product was distributed in the San Francisco Bay Area and Southern California in retail stores and restaurants.


Monday, June 23, 2008

Early Detection Of Osteoporosis Risk With Simple Ultrasound Exam Of Women's Heel.

OAK BROOK, Ill. – An ultrasound exam of the heel may be able to predict if a woman is at heightened risk for fractures due to osteoporosis, according to a new multicenter study being published in the July issue of the journal Radiology. Along with certain risk factors, including age or recent fall, radiation-free ultrasound of the heel may be used to better select women who need further bone density testing, such as a dual-energy x-ray absorptiometry (DXA) exam.

"Osteoporosis is a major public health issue expected to increase in association with worldwide aging of the population," said the study's lead author Idris Guessous, M.D., senior research fellow in the Department of Internal Medicine at Lausanne University Hospital in Switzerland. "The incidence of osteoporosis will outpace economic resources, and the development of strategies to better identify women who need to be tested is crucial."

Osteoporosis is a disease that is characterized by low bone mass and the deterioration of bone tissue and is a major public health threat. According to the National Osteoporosis Foundation, 10 million Americans currently have osteoporosis and approximately 34 million more are estimated to have low bone mass, increasing their risk of developing the disease. Eighty percent of those affected are women.

"Patients with osteoporosis are not optimally treated because of a lack of general awareness," Dr. Guessous said. "A simple prediction rule might be a useful clinical tool for healthcare providers to optimize osteoporosis screening."

In the three-year multicenter study, 6,174 women age 70 to 85 with no previous formal diagnosis of osteoporosis were screened with heel-bone quantitative ultrasound (QUS), a diagnostic test used to assess bone density. QUS was used to calculate the stiffness index, which is an indicator of bone strength, at the heel. Researchers added in risk factors such as age, history of fractures or a recent fall to the results of the heel-bone ultrasound to develop a predictive rule to estimate the risk of fractures. The results showed that 1,464 women (23.7 percent) were considered lower risk and 4,710 (76.3 percent) were considered higher risk.

Study participants where mailed questionnaires every six months for up to 32 months to record any changes in medical conditions, including illness, changes in medications or any fracture. If a fracture had occurred, the patients were asked to specify the fracture's precise location and trauma level and to include a medical report from the physician in charge.

In the group of higher risk women, 290 (6.1 percent) developed fractures whereas only 27 (1.8 percent) of the women in the lower risk group developed fractures. Among the 66 women who developed a hip fracture, 60 (90 percent) were in the higher risk group.

The results show that heel QUS is not only effective at identifying high-risk patients who should receive further testing, but also may be helpful in identifying patients for whom further testing can be avoided.

"Heel QUS in conjunction with clinical risk factors can be used to identify a population at a very low fracture probability in which no further diagnostic evaluation may be necessary," Dr. Guessous said.

Contact: Linda Brooks
lbrooks@rsna.org
630-590-7762
Radiological Society of North America

Weight Loss Through Big Breakfast Diat, Is It For You?

Researchers have found a possible way to overcome the common problem of dieters eventually abandoning their diet and regaining the weight they lost. Eat a big breakfast packed with carbohydrates ("carbs") and protein, then follow a low-carb, low-calorie diet the rest of the day, the authors of a new study recommend. Results were presented Tuesday, June 17, at The Endocrine Society's 90th Annual Meeting in San Francisco.

"Most weight loss studies have determined that a very low carbohydrate diet is not a good method to reduce weight," said lead author Daniela Jakubowicz, MD, of the Hospital de Clinicas, Caracas, Venzezuela. "It exacerbates the craving for carbohydrates and slows metabolism. As a result, after a short period of weight loss, there is a quick return to obesity."

Only five percent of carbohydrate-restrictive diets are successful after two years, Jakubowicz said. Most carbohydrate-restrictive diets, she said, do not address addictive eating impulses.

With scientists from Virginia Commonwealth University in Richmond, Jakubowicz and her colleagues conducted a study, which they said shows that a diet's long-term effectiveness depends on its ability to increase a sense of fullness and bring down carb cravings. They compared their new diet with a strict low-carb diet in 94 obese, physically inactive women. Both diets were low in fat and total calories but differed in the carbohydrate distribution.

Forty-six women were on the very-low-carb diet, which allowed them to eat 1,085 calories a day. The diet consisted of 17 grams of carbohydrates, 51 grams of protein and 78 grams of fat a day. The smallest meal was breakfast, at 290 calories. For breakfast the dieters were permitted only 7 grams of carbohydrates, such as bread, fruit, cereal and milk. Dieters could eat just 12 grams of protein, such as meat and eggs, in the morning.

On the modified low-carb diet, or "big-breakfast diet," the other 48 dieters ate 1,240 calories a day. Although lower in total fat (46 grams) than the other diet, the new diet had higher daily allotments of carbs (97 grams) and protein (93 grams). Dieters ate a 610-calorie big breakfast, consisting of 58 grams of carbs, 47 grams of protein and 22 fat grams. The diet schedule for lunch was 395 calories (34, 28 and 13 grams of carbs, protein and fat, respectively); dinner was 235 calories (5, 18 and 26 grams, respectively).

The first half of the eight-month study focused on weight loss, and the last four months on weight maintenance. At four months, the women on the strict low-carb diet dropped an average of about 28 pounds, and the women on the big-breakfast diet lost nearly 23 pounds on average, which according to Jakubowicz was not significantly different. But at 8 months, the low-carb dieters regained an average of 18 pounds, while the big-breakfast group continued to lose weight, shedding another 16.5 pounds. Those on the new diet lost more than 21 percent of their body weight, compared with just 4.5 percent for the low-carb group. Furthermore, the study found that women who ate a big breakfast reported feeling less hungry, especially before lunch, and having fewer cravings for carbs than the other women did.

Jakubowicz said the big-breakfast diet works because it controls appetite and cravings for sweets and starches. It also is healthier than an extremely low-carbohydrate diet, according to Jakubowicz, because it allows people to eat more fruit and therefore get enough fiber and vitamins. She said she has successfully used the diet in her patients for more than 15 years.


FDA's Ongoing Drug Safety Reviews On CellCept, Singulair, And Spiriva Handihaler.

FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information is preliminary and there is scientific uncertainty, FDA is not taking regulatory action at this point, and is not advising health care professionals to stop using the drugs. FDA is continuing to evaluate the safety of these products, and will issue updates as more information becomes available.

CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid)

One of the ongoing safety reviews concerns two drugs used to prevent organ rejection, CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid). CellCept is approved to prevent heart, liver and kidney transplant rejection. Myfortic is approved to prevent kidney transplant rejection.

This safety review focuses on a potential association between these drugs and a rare, life-threatening CNS disorder called or progressive multifocal leukoencephalopathy (PML). PML occurs when a latent polyoma virus called the JC virus is activated and attacks the myelin sheath surrounding nerve cells. Most adults carry the virus, which becomes activated mainly in immuno-compromised patients. Symptoms of PML include vision changes, apathy, memory loss or confusion, ataxia and muscular weakness.

FDA is reviewing data on the possible association between CellCept and PML. Roche, the manufacturer of CellCept, and Novartis, the manufacturer of Myfortic, have proposed changes in the labeling of these drugs to include information on PML.

Until FDA has more information, healthcare professionals should be alert to the localized neurologic signs and symptoms that could signal PML in patients taking CellCept and Myfortic. They should also consider reducing the amount of immuno-suppression if a patient develops PML.

Singulair (montelukast)

In another communication, FDA is informing healthcare professionals about a possible association between the use of Singulair and behavior and mood changes, suicidality and suicide. Singulair (montelukast) is used to treat asthma and allergic rhinitis, and to prevent exercise-induced asthma.

Singulair's manufacturer, Merck & Co., has updated the adverse events information in the drug's labeling several times over the past year. Those adverse events include tremor, depression, suicidality and anxiety. Merck plans to highlight these changes to prescribers, and to provide patient information leaflets on the drug.

FDA is reviewing reports of behavior and mood changes, suicidality and suicide in patients on Singulair, and has asked Merck to review its own clinical trial data for more information about suicide and suicidality. FDA will let clinicians and patients know about the results of these evaluations as soon as they're complete. In the meantime, patients on Singulair should be monitored for suicidality and changes in mood or behavior, and they should be instructed not to discontinue the drug without medical advice.

FDA is also reviewing reports of mood and behavioral changes in other asthma drugs, including Accolate (zafirlukast) and Zyflo (zileuton), and will decide whether further investigation is needed.
FDA's Ongoing Drug Safety Issues On CellCept, Singulair, And Spiriva Handihaler.
Spiriva Handihaler (tiotropium)

In another communication, FDA informed health professionals of a possible increase in the risk of stroke among patients using the Spiriva Handihaler. This product, which contains tiotropium bromide, is used to treat bronchospasm associated with chronic obstructive pulmonary disease.

The manufacturer, Boehringer Ingelheim, conducted a pooled analysis of 29 studies of two tiotropium products, including the Spiriva Handihaler. In this analysis, patients using Spiriva experienced a stroke risk of 8/1000 per year compared with 6/1000 per year for those using a placebo. Pooled analyses like this one have inherent limitations, and so these results must be confirmed by further investigation using other data sources.

FDA has asked for more information from Boehringer Ingelheim, and is also reviewing adverse event reports for this product. The company has conducted a large, four-year study of the Spiriva Handihaler which should provide more information on the potential risks of this product. Results are expected soon. At that point, FDA will analyze all of the data and report its results to health professionals and the public. In the meantime, patients should not stop using the Spiriva Handihaler without talking to their doctors.

Again, these communications are preliminary information, and they're in keeping with FDA's commitment to inform the public about its ongoing drug safety reviews. FDA urges healthcare professionals and patients to report adverse reactions from any of the products discussed here through FDA's Medwatch program at 1-800-FDA-1088 or at the link below.

FDA MedWatch Page. Voluntary Reporting by Health Professionals.
http://www.fda.gov/medwatch/report/hcp.htm

Synchromed and IsoMed Implantable Infusion Pumps Bring Increased Rate Of Inflammatory Masses

On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. This letter, which also gave patient management and treatment recommendations, was an update to two earlier communications.

The company's analysis shows that the incidence of inflammatory masses is about five times higher (about 0.5 percent vs. about 0.1 percent) than it was in 2001 and is expected to continue to increase. The masses occurred at or near the distal tip of the intrathecal catheters, and have been reported with a variety of intrathecal infusions, including opioids, baclofen and pharmacy-compounded drugs. The highest incidence was reported with opioid use. High doses or high concentrations of opioids may increase the risk of inflammatory mass, but the exact etiology is not known.

The company's recommendations for managing patients include the following:

• With intrathecal opioids, administer the lowest effective dose and concentration.

• Closely monitor patients to identify the prodromal signs and symptoms of inflammatory mass.

• Consider a neurological consultation and imaging studies to confirm or rule out the presence of an inflammatory mass.

Finally, Medtronic strongly advises physicians to know which intrathecal drugs are approved for use in these devices, including preservative-free morphine sulfate sterile solution, Lioresal® intrathecal baclofen injection, and preservative-free ziconotide sterile solution. The effect of administering other drugs through these devices has not been assessed, and that includes drugs compounded by pharmacies.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps. March 21, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation

Conventional And Atypical Antipsychotics Issues.

Antipsychotics, Conventional and Atypical
Audience: Neuropsychiatric and geriatrics healthcare professionals
FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

Friday, June 20, 2008

What Is Scleroderma? Fast Facts: An Easy-to-Read Series of Publications for the Public

Scleroderma

PDF Version of this Document


What Is Scleroderma?
Fast Facts: An Easy-to-Read Series of Publications for the Public

Scleroderma is a group of diseases that affect connective tissue in the body. This tissue supports your skin and internal organs. Scleroderma involves tissue that gets hard or thick. It can also cause swelling or pain in the muscles and joints.

Some types of scleroderma lead to hard, tight skin. Other types affect blood vessels and major organs (such as the heart, lungs, and kidneys).

What Causes Scleroderma?
What Are the Types of Scleroderma?
Who Gets Scleroderma?
How Is Scleroderma Diagnosed?
How Is Scleroderma Treated?
How Can Scleroderma Affect My Life?
What Can I Do?
What Research Is Being Done on Scleroderma?
For More Information About Scleroderma and Other Related Conditions
For Your Information

What Causes Scleroderma?

The cause is unknown. You can’t catch it from other people. Doctors don’t think it is passed through genes (from parent to child).

What Are the Types of Scleroderma?

Scleroderma’s main types are localized and systemic. Localized means the disease affects only certain parts of the body. Systemic means it can affect the whole body.

  • The localized type often affects only skin tissues. It does not harm major organs. It may get better or go away without help. But it can be severe in some people and can leave skin damage.
  • The systemic type affects the skin, tissues under it, blood vessels, and major organs.

Who Gets Scleroderma?

Scleroderma is more common in women than men. Anyone can get it, even children.

Most localized types show up before age 40, and are more common in people of European descent than in African Americans.

Systemic types are more common in people aged 30 to 50 and are more common in African Americans than in people of European descent.

How Is Scleroderma Diagnosed?

Doctors diagnose scleroderma using:

  • Your medical history
  • A physical exam
  • Lab tests
  • A skin biopsy.

Scleroderma can be hard to diagnose. Other diseases can have similar symptoms. It is easier to diagnose if you have:

  • Common symptoms
  • Skin that gets thick fast.

How Is Scleroderma Treated?

A rheumatologist (a doctor who treats arthritis and other diseases that cause swelling in the joints) may lead your health care team and refer you to other health experts for problems with:

  • Skin
  • Kidneys
  • Heart
  • Digestion
  • Lungs
  • Teeth
  • Movement
  • Speech.

Scleroderma has no cure. But symptoms and damage can be reduced. Below are some problems and treatments for systemic scleroderma. These problems don’t happen with localized scleroderma.

Raynaud’s Phenomenon

Most people with scleroderma have Raynaud’s phenomenon. It can affect the fingers, feet, and hands. It makes them change color if you are too cold or anxious. To help, you can:

  • Not smoke
  • Dress warm, and keep hands and feet warm
  • Do exercises that relax the body
  • Ask about medicines that open small blood vessels and help with blood flow
  • Ask about medicines that treat skin sores and ulcers.
Stiff, Painful Joints

Stiffness and pain come from hard skin around joints and joint swelling. To help, you can:

  • Do stretching exercises that help with joint motion.
  • Exercise regularly (swimming is best).
  • Take medicine to help ease pain or swelling. Ask your doctor which are the best for you to take.
  • Learn to do daily tasks in ways that put less stress on the joints.
Skin Problems

With scleroderma, collagen builds up in the skin. Too much of it can make your skin dry and stiff. To help, you can:

  • Use oil-based creams and lotions after every bath.
  • Use sunscreen.
  • Use a humidifier at home.
  • Avoid hot baths or showers.
  • Avoid strong soaps, cleaners, and chemicals. Wear rubber gloves if you have to use those products.
  • Exercise regularly.
Dry Mouth and Dental Problems

If you have tight skin on your face, you may have trouble caring for your teeth. Dry mouth speeds up tooth decay. Harm to tissues in the mouth can loosen teeth. To avoid problems:

  • Brush and floss your teeth each day.
  • Have frequent dental checkups.
  • See your dentist if you have mouth sores, mouth pain, or loose teeth.
  • Ask your dentist about special rinses and toothpastes.
  • Learn ways to keep your mouth and face flexible.
  • Keep your mouth moist. You can drink lots of water or suck on ice chips. You can also chew gum or suck on hard candy that has no sugar added.
  • Avoid mouthwash that has alcohol.

If dry mouth still bothers you, ask your doctor about helpful medicines.

Gastrointestinal Problems

Digestive problems can include:

  • Heartburn
  • Trouble swallowing
  • Feeling full as soon as you start eat eating
  • Diarrhea, constipation, and gas.

To help, you can:

  • Eat small, frequent meals
  • Stand or sit for 1 to 3 hours after eating
  • Use blocks to raise the head of your bed
  • Avoid late-night meals, spicy or fatty foods, alcohol, and caffeine
  • Eat moist, soft foods, and chew them well
  • Ask your doctor about medicines for diarrhea, constipation, and heartburn.
Lung Damage

Problems include:

  • Some loss of lung function
  • Severe lung disease
  • Scarring of lung tissue
  • High blood pressure in the artery that carries blood from the heart to the lungs.

Watch for signs of lung disease, such as:

  • Fatigue
  • Shortness of breath
  • Problems with breathing
  • Swollen feet.

As soon as your skin starts to thicken, see your doctor. Get regular flu and pneumonia shots.

Heart Problems

Problems include:

  • Scarring and weakness
  • Swelling of the heart muscle
  • A heartbeat that isn’t normal.

These problems can all be treated.

Kidney Problems

Scleroderma can cause very high blood pressure and kidney failure in some people. Learn to spot problems right away.

You should:

  • Check your blood pressure often
  • Check your blood pressure if you have new symptoms
  • Call your doctor if your blood pressure is higher than normal
  • Take the medicines your doctor prescribes.
Cosmetic Problems

Scleroderma can damage your skin and change how it looks. These skin changes can affect your self-image. Ways to fix skin damage include:

  • Lasers that take away red spots on the hands and face
  • Plastic surgery in areas where the disease is not active.

How Can Scleroderma Affect My Life?

People with scleroderma may worry about the way their skin looks. They may have problems dressing, bathing, or handling basic daily tasks. Scleroderma can affect:

  • The way you look
  • How you feel about yourself
  • How you take care of yourself
  • Family relationships
  • Sexual relations
  • Having a baby.

What Can I Do?

You and your doctors are partners in your treatment. Be sure to:

  • Take your prescribed medicines
  • Follow your doctor’s advice
  • Quickly report problems.

You can also:

  • Learn about the disease
  • Look for support from family and friends or a support group
  • Get help for depression and other problems
  • Learn coping skills.

What Research Is Being Done on Scleroderma?

Current studies include:

  • Research to understand the genes that might be involved in scleroderma.
  • Ultraviolet light to treat skin problems
  • Medicines to keep skin from getting thick and to treat kidney and lung problems.

Research and new treatments have helped people with scleroderma do better and stay active much longer than they did in the past.

For More Information About Scleroderma and Other Related Conditions:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information Clearinghouse
National Institutes of Health

1 AMS Circle
Bethesda, MD 20892-3675
Phone: 301-495-4484
Toll Free: 877-22-NIAMS (226-4267)
TTY: 301–565–2966
Fax: 301-718-6366
Email: NIAMSinfo@mail.nih.gov
Website: http://www.niams.nih.gov

LIPITOR Patent Litigation Settled, Ranbaxy Will Market Generic Atorvastatin In The U.S.A

Ranbaxy will Market Generic Atorvastatin in the U.S. with 180 Days Exclusivity from Nov. 30, 2011

Agreement Also Resolves Caduet, Accupril Litigation in the US

Gurgaon, Harayana, India; Princeton, NJ, USA – June 18 , 2008

Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12.7 billion .

The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the United States. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective Nov. 30, 2011.

Welcoming the development, Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd., said, “This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. It also provides certainty and visibility to the launch of Ranbaxy’s Generic Atorvastatin, with180 day market exclusivity in the US and an early entry in other markets. This will make the worlds largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option.”

Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam.

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer’s patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.

The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

Food Safety During the Summer Months.

OTTAWA - Now that summer is here, and picnics, summer camp lunches and barbeques are being enjoyed across the country, Health Canada would like to remind Canadians of four simple steps they can take to protect themselves from food-borne illnesses: clean, separate, cook and chill.

Now that summer is here, and picnics, summer camp lunches and barbeques are being enjoyed across the country, Health Canada would like to remind Canadians of four simple steps they can take to protect themselves from food-borne illnesses: clean, separate, cook and chill.

As the temperature rises, so does the risk of food-borne illness. Hot, humid weather creates the perfect conditions for the rapid growth of bacteria. Summer also means more people are cooking outside at picnics, barbeques and camping trips, without easy access to refrigeration and washing facilities to keep food safe.

It is estimated that there are as many as 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

To minimize the risks of food-borne illness, follow these four easy steps when handling and preparing food.

Step One - Clean: Wash hands and surfaces often to avoid the spread of bacteria.

  • Wash your hands with hot, soapy water for at least 20 seconds before handling food, and after handling raw meats or poultry, using the bathroom, touching pets or changing diapers.
  • Always wash raw fruits and vegetables in clean water. You cannot tell whether foods carry surface bacteria by the way they look, smell or taste.

Step Two - Separate: Keep raw meats and poultry separate from cooked foods to avoid cross-contamination.

  • When you pack a cooler for an outing, wrap uncooked meats and poultry securely, and put them on the bottom to prevent raw juices from dripping onto other foods.
  • Wash all plates, utensils, and cutting boards that touched or held raw meat or poultry before using them again for cooked foods.

Step Three - Cook: Make sure you kill harmful bacteria by properly cooking food.

Traditional visual cues like colour are not a guarantee that food is safe. Don=t guess! Take a digital instant-read food thermometer along to check when meat and poultry are safe to eat.

  • Cooked foods are safe to eat when internal temperatures are:

    • 71° C (160° F) for ground meat
    • 74° C (165° F) for leftover food and boned and deboned poultry parts
    • 85° C (185° F) for whole poultry

Step Four - Chill: Keep cold food cold.

  • Perishable foods that are normally in the refrigerator, such as luncheon meats, cooked meat, chicken, and potato or pasta salads, must be kept in an insulated cooler with freezer packs or blocks of ice to keep the temperature at or near 4° C (40° F).
  • Put leftovers back in the cooler as soon as you are finished eating.
  • The simple rule is: When in doubt, throw it out.

Do Not Use 6-OXO and 1-AD Dietary Supplements By ErgoPharm / Proviant Technologies, Health Canada Advisory.

OTTAWA - Health Canada is warning consumers not to use the dietary supplements 6-OXO (4-androstene-3,6,17-trione) and 1-AD (1-androstenediol), or any other supplements containing the ingredients 4-androstene-3,6,17-trione or 1-androstenediol, due to potentially serious health risks such as seizures and blood clots in the brain that can lead to disability.

Both 6-OXO and 1-AD are manufactured by ErgoPharm / Proviant Technologies in Champaign, Illinois. They are promoted as dietary supplements for body building, and are not authorized for sale in Canada. Health Canada has received one domestic adverse reaction case report in which an individual with no known predisposing medical conditions developed seizures and blood clots in his brain, associated with the use of 6-OXO and 1-AD.

6-OXO, which contains the compound 4-androstene-3,6,17-trione, is an unauthorized natural health product in Canada. 1-AD contains 1-androstenediol, an anabolic steroid that is regulated as a controlled substance in Canada, meaning it should only be dispensed by prescription and used under the supervision of a health professional. While neither product is authorized for sale in Canada, Canadians can access them over the Internet or purchase them while travelling abroad. The above-mentioned Canadian adverse reaction case involved a consumer who purchased the products in the U.S. and brought them into Canada through personal importation.

Consumers using 6-OXO, 1-AD, or other supplements containing 4-androstene-3,6,17-trione or 1-androstenediol without a prescription, are advised to stop taking the products immediately and consult with a health care professional if they have health concerns. Health Canada is taking action to prevent further importation of 6-OXO and 1-AD into Canada.

Health Canada is also reminding consumers to be cautious regarding the purchase of health products over the Internet or from outside of Canada, as these products may not have been assessed to the same standards as products approved for sale on the Canadian market. Authorized health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Drug Number (DIN-HM). This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.

Consumers should contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find 6-OXO or 1-AD or any other supplements containing 4-androstene-3,6,17-trione, or 1-androstenediol being sold at a Canadian retail outlet without a prescription.

Consumers requiring more information about this warning can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

Animal Food Products Seized From PETCO Distribution Center.

FOR IMMEDIATE RELEASE
June 19, 2008

Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term "insanitary" to describe such conditions).

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."

The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.

As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.

If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.

Wednesday, June 18, 2008

United States and China sign a Joint Progress Statement on Food and Feed Safety

United States and China Outline Progress on Agreement on Food and Feed Safety

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

The parties are meeting this week in Annapolis, Md., as part of the fourth session under the United States-China Strategic Economic Dialogue (SED).

“Today's progress report reflects strong and sustained cooperation by both nations to strengthen the safety of food products exported to the United States from China,” Secretary Leavitt said. “I'm very pleased with our efforts and commend our Chinese counterparts for their commitment to this important work.”

The MOA, signed during the third session under the SED in December of 2007, established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. Since its signing, HHS’ Food and Drug Administration (FDA) and AQSIQ have planned a joint implementation work strategy and have begun the initial steps called for under the agreement.

The statement describes progress in several important areas:

  • Establishment of a mechanism for cooperation on significant events related to food and feed safety, including designated points of contact, emergency contacts, and thresholds for notifications; enhancing the exchange of information on the safety of food and feed safety; and developing a better understanding by both sides of each others’ respective regulatory systems.
  • Development of concrete steps that will lead to a system whereby AQSIQ will electronically certify to FDA that specific products sent for export to the United States meet FDA standards for safety and manufacturing quality.
  • Focus efforts on inspections and supervision and laboratory testing standards to ensure food and feed safety. The United States agreed to conduct training for Chinese officials on U.S. regulatory standards and requirements.
  • Establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.

HHS/FDA and Chinese officials continue to work on implementing a second Memorandum of Agreement signed in December to enhance the safety of a variety of medical products.

For more information on the December 2007 MOA on the Safety of Food and Feed, go to http://globalhealth.gov/news/agreements/ia121107b.html.

To view the Joint Progress Statement Regarding the Five-Year Work Plan under the MOA, visit http://www.fda.gov/bbs/topics/news/international/progress_HHS_China.pdf.

NeuRx DPS RA/4 Respiratory Stimulation System Approved By FDA

FOR IMMEDIATE RELEASE
June 18, 2008

Media Inquiries:
Peper Long, 301-827-0599
Consumer Inquiries:
888-INFO-FDA


FDA Approves Diaphragm-Pacing Device
Device can help paralysis patients breathe without a ventilator for at least four hours

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

Spinal cord injuries can cause paralysis, which can impact the muscles of the chest and abdomen, including the diaphragm—the lower abdominal muscle essential for breathing. Normally, a person inhales when the diaphragm contracts and the lungs expand with air—a person exhales when the diaphragm relaxes and the air flows back out of the lungs.

"While the NeuRx RA/4 does not cure paralysis of the diaphragm, allowing patients to be free from a mechanical ventilator for at least four hours a day may enhance their quality of life," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.

Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine.

The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale.

The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose conditions that affect fewer than 4,000 people per year.

In a multi-center trial, the device has been demonstrated to be safe and to have probable benefit to the patient by allowing at least four hours per day of freedom from a mechanical ventilator.

NeuRx DPS RA/4 is manufactured by Synapse Biomedical of Cleveland, Ohio.

FDA Warns Against Fake Cancer 'Cures' Fraudulent claims on Internet sites

FOR IMMEDIATE RELEASE
June 17, 2008

Media Inquiries:
Rita Chappelle, (301) 827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Fraudulent claims on Internet sites

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Those companies and individuals warned, the complete list of fake cancer 'cure' products and their manufacturers along with a consumer article on health scams can be found here, http://www.fda.gov/cder/news/fakecancercures.htm.

"Although promotions of bogus cancer 'cures' have always been a problem, the Internet has provided a mechanism for them to flourish," said Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs. "These warning letters are an important step to ensure that consumers do not become the victim of false 'cures' that may cause greater harm to their health."

The FDA urges consumers to consult their health care provider about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.

The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.

Because these products claim to cure, treat, mitigate or prevent disease, and these products have not been shown to be safe and effective for their labeled conditions of use, they are unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Examples of fraudulent claims for these products include:

  • "Treats all forms of cancer"
  • "Causes cancer cells to commit suicide!"
  • "80% more effective than the world's number one cancer drug"
  • "Skin cancers disappear"
  • "Target cancer cells while leaving healthy cells alone"
  • "Shrinks malignant tumors"
  • "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"

The Warning Letters are part of the FDA's ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico–United States–Canada Health Fraud Working Group. Earlier this year, FTC sent Warning Letters to 112 Web sites falsely promoting cancer "treatments" and referred several others to foreign authorities.

Parties that fail to properly resolve violations cited in Warning Letters are subject to enforcement action up to and including seizure of illegal products, injunction, and possible criminal prosecution.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm .

To read about efforts in Canada to educate consumers about health scams, go to http://www.competitionbureau.gc.ca/epic/site/cb-bc.nsf/en/02614e.html .

Older Class of Antipsychotic Drugs To Carry Warnings As Per FDA Request.

FOR IMMEDIATE RELEASE
June 16, 2008

Media Inquiries:
Sandy Walsh, 301-827-3418
Consumer Inquiries:
888-INFO-FDA


FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."

Antipsychotic drugs commonly are categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or "tics."

Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.

Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

An explanation of the data and advice for treating patients is available in an FDA notice to health care professionals being issued today.

The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient's health care professionals about any concerns.

The medications involved in this action are:

Conventional Antipsychotic Drugs

Atypical Antipsychotics

Compazine (prochlorperazine)

Abilify (aripiprazole)

Haldol (haloperidol)

Clozaril (clozapine)

Loxitane (loxapine)

FazaClo (clozapine)

Mellaril (thioridazine)

Geodon (ziprasidone)

Moban (molindrone)

Invega (paliperidone)

Navane (thithixene)

Risperdal (risperidone)

Orap (pimozide)

Seroquel (quetiapine)

Prolixin (fluphenazine)

Zyprexa (olanzapine)

Stelazine (trifluoperazine)

Symbyax (olanzapine and fluoxetine)

Thorazine (chlorpromazine)


Trilafon (perphenazine)


For more information, see

FDA Information for Healthcare Professionals: Antipsychotics
http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm

FDA Historical Information on Atypical Antipsychotic Drugs
http://www.fda.gov/cder/drug/infopage/antipsychotics/antipsychotics_historical.htm

Monday, June 16, 2008

Steps to Prevent Foodborne Illnesses in Fresh Tomatoes

Information Update
2008-92
June 14, 2008
For immediate release

OTTAWA - Health Canada would like to remind Canadians of the importance of proper handling and preparation of fresh tomatoes in order to prevent foodborne illness.

Tomatoes can be part of a nutritious diet and are a great source of vitamins and minerals, according to Canada's Food Guide. Tomatoes are fruits and are commonly red but can also come in a variety of other colours, such as yellow, pink and purple. Tomatoes are often eaten fresh or used as an ingredient in recipes. Popular types of tomatoes include beefsteak, plum and cherry tomatoes.

How can tomatoes become contaminated?

Fresh field tomatoes and other fruits and vegetables don't naturally contain bacteria that can make you sick.

Since tomatoes are grown close to the ground, the fruit can become contaminated in the field by soil, contaminated water, wild and domestic animals or improperly composted manure. Bacteria may also be transferred during and after harvest from handling, storing and transporting.

Fresh fruit and vegetables, including tomatoes, can also become contaminated with disease-causing bacteria when they come into contact with raw food items such as meat, poultry, seafood and their juices. Such contaminations can happen at the grocery store, in the shopping cart, in the refrigerator or from counters and cutting boards at home.

How do I select tomatoes at the grocery store?

When you buy tomatoes, you should look for any signs of bruising or cuts on the skin, and flesh of the tomato. Because they continue to ripen once they are picked, you should always purchase tomatoes that are firm but not hard.

Storing tomatoes

Store whole tomatoes unwashed and uncovered at room temperature. Make sure that they are stored out of direct sunlight. When the tomatoes are ripe, they should be stored in the refrigerator and should be used within a few days.

Cut tomatoes should always be refrigerated at 4ºC (40ºF) or less and can be kept for up to three days. If the cut or peeled tomatoes have been left out at room temperature for more than two hours, you should throw them away.

Since tomatoes can become contaminated by coming into contact with raw meat, poultry or seafood, be sure to separate raw foods from ready-to-eat foods in the shopping cart at the grocery store, and in the kitchen and refrigerator at home.

Cleaning and preparing tomatoes

You should always wash your hands before handling any fresh produce. Wash your tomatoes under fresh, running water. Make sure you throw out any tomatoes that are bruised or spoiled. Don't soak tomatoes in a sink full of water because the sink can harbour bacteria that can be transferred to the tomatoes.

There is no need to use anything other than water when washing tomatoes. Produce washes may not completely remove or kill bacteria, viruses and parasites. Washing tomatoes under fresh, cool running water gently is as effective, if not more so, as using cleansers.
When you are finished washing your tomatoes, cut out the scar where the stem was, and throw it away.

Foodborne Illness and Symptoms

Foodborne illness or food poisoning happens when a person gets sick from eating foods that are contaminated with microorganisms like bacteria, parasites or viruses. Bacteria most commonly linked to tomato foodborne outbreaks is Salmonella.

The most common symptoms of foodborne illness include:

  • Stomach cramps
  • Nausea
  • Vomiting
  • Diarrhea
  • Fever

It is estimated that there are as many as 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

What is the Government of Canada doing about the safety of fresh produce?

The Government of Canada and industry work together to help identify best practices that can be used to help prevent contamination of fresh produce throughout the food system, from the field to the store. In addition, inspection and enforcement activities conducted by the Canadian Food Inspection Agency work to ensure that steps taken by producers, manufacturers and importers have been effective and that the foods available to Canadians are safe.

FDA Issues a Warning (Cancer Risk) for Regranex—Cream for Leg and Foot Ulcers

Warning for Regranex—Cream for Leg and Foot Ulcers

On June 6, 2008, the Food and Drug Administration (FDA) announced that a boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin). The warning addresses the increased risk of cancer death in patients who use three or more tubes of the product.

Regranex is a topical cream for treating leg and foot ulcers that are not healing in patients with diabetes. A boxed warning on a drug's label calls attention to serious or life-threatening risks.

What is the basis for the revised label?

A study compared cancer incidence and cancer death among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed to the product. Although the study showed no overall increase in cancer incidence among the patients exposed to Regranex, there was a five-fold increased risk of cancer death in the group exposed to three or more tubes of the product.

What is FDA advising in regard to Regranex?

In announcing this label change, FDA cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex. The product is not recommended for patients with known malignancies (cancerous tumors).

FDA urges health care professionals to promptly report serious and unexpected adverse reactions associated with Regranex to FDA's MedWatch reporting program. MedWatch reports may be submitted the following ways:

Collaborative effort by FDA and EMEA expected to yield additional safety data For Drug Safety

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
Collaborative effort by FDA and EMEA expected to yield additional safety data

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

The new biomarkers are KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA.

"The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs."

Woodcock added that such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products.

Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA.

The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process.

The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers.

FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. For example, in experiments using rats, the two traditional tests can only detect kidney damage a week after it has begun to occur. The new tests, however, are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected.

The seven new tests were developed and will be carried out initially in rats. These tests were selected because other studies have shown that identical biomarkers are produced in human kidney cells. While the FDA and EMEA will consider these biomarkers in rat studies initially, the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.

Link to the Predictive Safety Testing Consortium:
http://c-path.org/PredictiveSafetyTestingConsortium/tabid/219/Default.aspx

Thursday, June 12, 2008

This Barbeque Season, Be Careful With Your Hamburgers! And Stay Healthy.

Following is an advisory by Health Canada but apply equally well to everyone every where who are planing to have barbecue parties. Please be careful and have a healthy Summer!


OTTAWA - Barbeque season has begun and Health Canada would like to remind Canadians of steps they can take to avoid food borne illness from E. coli bacteria from ground beef.

Eating undercooked ground beef can result in a type of food borne illness commonly called hamburger disease, caused by E. coli bacteria. Symptoms can include severe stomach cramps, vomiting, fever and diarrhea. Hamburger disease can be avoided by handling and cooking raw ground beef carefully.

Before you grill:

  • When at the grocery store, be sure to keep raw meat separate from other products. Put packages of raw meat in separate plastic bags to keep meat juices from leaking onto other foods.
  • Wash your hands thoroughly before and after handling any raw food, especially raw meat, poultry and seafood.
  • Make your hamburger patties thin so that they will easily cook all the way through.
  • Keep raw hamburger meat away from other hamburger fixings, such as lettuce, tomato, cheese and condiments.
  • Use hot, soapy water to clean all surfaces that come into contact with raw meat.

When you cook:

  • Your beef hamburger (fresh or frozen) is done when its internal temperature reaches 71°C (160°F). Recommended internal temperatures for other types of hamburgers may be higher.
  • Colour alone is not a reliable indicator that a hamburger is safe to eat. Hamburgers can turn brown before all bacteria are killed, so use a digital food thermometer to be sure.
  • To check the temperature of a beef hamburger, take the patty from the grill and insert the digital food thermometer through the side, all the way to the middle of the patty. If you're cooking more than one patty, be sure to check the temperature of all the hamburgers.
  • Use clean utensils and plates when removing cooked meats from the grill.
  • Remember to wash the thermometer in hot, soapy water between temperature readings.

It is estimated that there are as many as 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.


Be Prepared And Keep Your Food Safe During an Emergency

Be Prepared And Keep Your Food Safe During an Emergency
WASHINGTON, June 5, 2008 - The U.S. Department of Agriculture is providing recommendations to those affected by severe storms and tornadoes in the Mid-Atlantic region. USDA is hopeful that this information will help minimize the potential for foodborne illnesses due to power outages and other problems that are often associated with severe weather events.

"Power outages can occur at any time of the year and it often takes from a few hours to several days for electricity to be restored to residential areas," said USDA Under Secretary for Food Safety Dr. Richard Raymond. "Without electricity or a cold source, foods stored in refrigerators and freezers can become unsafe. Bacteria in food grow rapidly at temperatures between 40 and 140 °F, and if these foods are consumed, people can become very sick."

Steps to follow to prepare for a possible weather emergency:

  • Keep an appliance thermometer in the refrigerator and freezer. An appliance thermometer will indicate the temperature in the refrigerator and freezer in case of a power outage and help determine the safety of the food.
  • Make sure the freezer is at 0 °F or below and the refrigerator is at 40 °F or below.
  • Freeze containers of water for ice to help keep food cold in the freezer, refrigerator or coolers after the power is out.
  • Freeze refrigerated items such as leftovers, milk and fresh meat and poultry that you may not need immediately — this helps keep them at a safe temperature longer.
  • Plan ahead and know where dry ice and block ice can be purchased.
  • Store food on shelves that will be safely out of the way of contaminated water in case of flooding.
  • Have coolers on hand to keep refrigerator food cold if the power will be out for more than 4 hours. Purchase or make ice cubes and store in the freezer for use in the refrigerator or in a cooler. Freeze gel packs ahead of time for use in coolers.
  • Group food together in the freezer — this helps the food stay cold longer.

Steps to follow after the weather emergency:
  • Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.
  • The refrigerator will keep food safely cold for about 4 hours if it is unopened. A full freezer will hold the temperature for approximately 48 hours (24 hours if it is half full) and the door remains closed.
  • Discard refrigerated perishable food such as meat, poultry, fish, soft cheeses, milk, eggs, leftovers and deli items after 4 hours without power.
  • Food may be safely refrozen if it still contains ice crystals or is at 40 °F or below when checked with a food thermometer.
  • Never taste a food to determine its safety!
  • Obtain dry or block ice to keep your refrigerator and freezer as cold as possible if the power is going to be out for a prolonged period of time. Fifty pounds of dry ice should hold an 18-cubic-foot full freezer for 2 days.
  • If the power has been out for several days, check the temperature of the freezer with an appliance thermometer. If the appliance thermometer reads 40 °F or below, the food is safe to refreeze.
  • If a thermometer has not been kept in the freezer, check each package of food to determine its safety. If the food still contains ice crystals, the food is safe.
  • Drink only bottled water if flooding has occurred.
  • Discard any food that is not in a waterproof container if there is any chance that it has come into contact with flood water. Discard wooden cutting boards, plastic utensils, baby bottle nipples and pacifiers.
  • Undamaged, commercially prepared foods in all-metal cans and retort pouches (for example, flexible, shelf-stable juice or seafood pouches) can be saved. Follow the Steps to Salvage All-Metal Cans and Retort Pouches below at the end of this document.
  • Thoroughly wash all metal pans, ceramic dishes and utensils that came in contact with flood water with hot soapy water and sanitize by boiling them in clean water or by immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water.
  • When in Doubt, Throw it Out!

Steps to Salvage All-Metal Cans and Retort Pouches
Undamaged, commercially prepared foods in all-metal cans and retort pouches (for example, flexible, shelf-stable juice or seafood pouches) can be saved if you do the following:
  • Remove the labels, if they are the removable kind, since they can harbor dirt and bacteria.
  • Thoroughly wash the cans or retort pouches with soap and water, using hot water if it is available.
  • Brush or wipe away any dirt or silt.
  • Rinse the cans or retort pouches with water that is safe for drinking, if available, since dirt or residual soap will reduce the effectiveness of chlorine sanitation.
  • Then, sanitize them by immersion in one of the two following ways:
    • Place in water and allow the water to come to a boil and continue boiling for 2 minutes, or
    • Place in a freshly made solution consisting of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available) for 15 minutes.
  • Air-dry cans or retort pouches for a minimum of 1 hour before opening or storing.
  • If the labels were removable, then re-label your cans or retort pouches, including the expiration date (if available), with a marker.
  • Food in reconditioned cans or retort pouches should be used as soon as possible, thereafter.
  • Any concentrated baby formula in reconditioned, all-metal containers must be diluted with clean, drinking water.

Tuesday, June 10, 2008

Salmonellosis Outbreak , Red Tomato Warning By FDA Expanded Nationwide

Red Tomato Warning Expanded Nationwide

We have been reporting about this Tomato scare for a while;
Raw Red Tomatoes Advisory (Do Not Eat!) Extends Nationwide

FDA Warning, New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes, Salmonella Outbreak
Now FDA has expanded the warning nationwide.


The Food and Drug Administration (FDA) is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, raw red Roma, raw red round tomatoes, and products containing these tomatoes.

FDA recommends that consumers not eat these tomatoes unless they have been grown and harvested from states, countries, and territories that have NOT been associated with this outbreak. The list, which will be updated as more information becomes available, can be found at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers.

FDA also recommends that retailers, restaurants, and other food service operators not offer raw red Roma, raw red plum, and raw red round tomatoes unless they are from sources that have not been associated with the outbreak. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made.

The following types of tomatoes are NOT likely to be the source of this outbreak. Consumers should continue to eat

  • cherry tomatoes
  • grape tomatoes
  • tomatoes sold with the vine still attached
  • tomatoes grown at home

Since mid-April 2008, there have been at least 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin.

For More Information

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01848.html

Monday, June 09, 2008

Transition to CFC-free Ozone-Safe Metered Dose Inhalers

EPA has released a press release regarding the discontinuation of CFC based inhalers. EPA phased out chlorofluorocarbons (CFCs) in 1996, with limited exemptions. One of those exemptions is production and import of CFCs for use in essential use inhalers to treat asthma and chronic obstructive pulmonary disease.
We reported about the initial FDA announcement;
Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

Transition to CFC-free Metered Dose Inhalers Moves Forward

Release date: 06/06/2008

Contact Information: Cathy Milbourn, (202) 564-4355 / milbourn.cathy@epa.gov


(Washington, D.C. - June 6, 2008) For the 2008 calendar year, EPA has allocated 27.0 metric tons of CFC-114 for the manufacture of epinephrine metered dose inhalers (inhalers). In accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer and the Clean Air Act, EPA phased out chlorofluorocarbons (CFCs) in 1996, with limited exemptions. One of those exemptions is production and import of CFCs for use in essential use inhalers to treat asthma and chronic obstructive pulmonary disease.

Each year, in coordination with the U.S. Food and Drug Administration (FDA), EPA allocates essential use allowances to pharmaceutical companies to manufacture essential use inhalers that use CFCs as a propellant. Essential use allowances permit the production and importation of CFCs after the 1996 phaseout solely for manufacturing essential use inhalers. FDA's determination is based on the amount of CFC inhalers necessary to protect public health.

The transition to CFC-free inhalers is well underway and is part of a larger transition that has affected many other consumer and industrial products and sectors over the last several decades. Since 1996, EPA has significantly reduced the amount of CFCs allocated to pharmaceutical companies to manufacture essential use inhalers. In 1998, EPA allocated 4,365 metric tons, and in 2007, allocated 167.0 metric tons.

An important factor in the transition to CFC-free inhalers - although separate from today's CFC allocation rule – is an upcoming prohibition on the sale and distribution of CFC-propelled inhalers containing albuterol. After Dec. 31, 2008, EPA regulations will prohibit the sale and distribution of CFC-albuterol metered dose inhalers. There are now four albuterol inhalers available propelled by ozone-safe hydrofluoroalkanes (HFAs), rather than CFCs.

To foster coordination and education between patients and health-care providers, on May 30, 2008, FDA issued a public health advisory to alert patients, caregivers, and health care professionals that CFC-propelled albuterol inhalers will not be available after Dec. 31, 2008.

Raw Red Tomatoes Advisory (Do Not Eat!) Extends Nationwide

FOR IMMEDIATE RELEASE
June 7, 2008

Media Inquiries:
Kimberly Rawlings, 301-827-6253
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes

The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.

On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, Hawaii, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers. This list will be updated as more information becomes available.

FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached.

FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.

Since mid April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.

FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan, a scientific and risk-based approach to strengthen and protect the nation’s food supply.

FDA will continue to issue updates as more specific information becomes available.

Friday, June 06, 2008

Recallr: Health Canada Update on Foreign Toothpaste Containing Diethylene Glycol (DEG)

Diethylene Glycol (DEG) is a harmful chemical and was present in toothpastes that are illegal. Several Countries have recalled these toothpastes.
Recallr: Health Canada Update on Foreign Toothpaste Containing Diethylene Glycol (DEG)

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Recallr: Kraft Foods Recalls LiveActive Mixed Berry Crunch Cereal Under POST Brand.

Check your cupboards for this cereal, specially if you are allergic to nuts.
Recallr: Kraft Foods Recalls LiveActive Mixed Berry Crunch Cereal Under POST Brand.

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Heartworm Drug Return to U.S. Market, In A Limited Form.

FOR IMMEDIATE RELEASE
June 5, 2008

Media Inquiries:
Kimberly Rawlings and
Mike Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Announces Limited Return of Heartworm Drug to U.S. Market

The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.

ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.

"This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs," said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. "While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions."

Heartworm disease is a serious and potentially fatal condition for dogs. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.

The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product.

The return of ProHeart 6 to the market is based on results of additional toxicological and pharmacologic studies by Fort Dodge Animal Health coupled with the low adverse reaction frequency in international markets.

In 2004, Fort Dodge Animal Health agreed to voluntarily recall the product from the market based upon FDA's concerns regarding reports of serious adverse reactions in dogs following the use of ProHeart 6. In response to FDA's concerns, the manufacturer conducted additional testing of its product, which indicated that residues of the solvents used in the manufacture of ProHeart 6 may cause allergic reactions.

The manufacturer has improved the manufacturing specifications for ProHeart 6 to decrease the presence of those residues and has marketed the product in international markets. Few adverse events have been reported with this reformulated product.

The ProHeart 6 label and Client Information Sheet have been revised to include updated safety information. The new label includes warnings not to administer the drug within one month of vaccinations, and to use the product with caution in dogs with pre-existing allergic diseases including food allergies, allergic hypersensitivity, and flea allergy dermatitis. The label also warns against administering the drug to dogs who are sick, debilitated, underweight, or who have a history of weight loss. In addition, the label’s Post-Approval Experience section has been updated to include information about adverse reactions based on voluntary post-approval drug experience reporting.

Dog owners who suspect their dog is experiencing an adverse reaction to ProHeart 6 should immediately contact their veterinarian to initiate appropriate veterinary care. Veterinarians should contact Fort Dodge Animal Health to report any adverse events at (800) 533-8536.

KEMADRIN® (procyclidine hydrochloride) tablets Discontinued.

King Pharmaceuticals®, Inc. has decided to discontinue the manufacture of KEMADRIN® (procyclidine hydrochloride) tablets. KEMADRIN® tablets will remain available through pharmacies and wholesalers until current supplies are depleted.

KEMADRIN® tablets are distributed through King Pharmaceuticals®, Inc. No additional product will be available after King, pharmacy, and wholesaler supplies are exhausted.

If you have any questions or concerns, you may contact our Professional Information Services Department at 800-776-3637.

KEMADRIN® (procyclidine hydrochloride) is a synthetic antispasmodic compound indicated in the treatment of parkinsonism including the postencephalitic, arteriosclerotic, and idiopathic types. Partial control of the parkinsonism symptoms is the usual therapeutic accomplishment.

Letter from King Pharmaceuticals PDF document

CORTISPORIN® Ophthalmic Suspension Discontinued.

King Pharmaceuticals®, Inc. has decided to discontinue the manufacture of CORTISPORIN® Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension).
CORTISPORIN® Ophthalmic Suspension will remain available through pharmacies and wholesalers until current supplies are depleted.
CORTISPORIN® Ophthalmic Suspension is distributed through King Pharmaceuticals®, Inc. No additional product will be available after King, pharmacy, and wholesaler supplies are exhausted.
If you have any questions or concerns, you may contact our Professional Information Services Department at 800-776-3637. CORTISPORIN® Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) is a sterile antimicrobial and anti-inflammatory suspension indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Letter from King Pharmaceuticals PDF document

New Labeling Changes for Regranex Gel 0.01% (becaplermin)

FDA Announces New Labeling Changes for Regranex
Product to carry boxed warning

The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

To read about Regranex and FDA's follow-up communication go to:

Becaplermin (marketed as Regranex) Information

Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin)

Wednesday, June 04, 2008

Tyson Foods Culls Breeder Hens Exposed To A Low Pathogenic Strain Of Avian Influenza (LPAI).

June 3, 2008 -- Tyson Foods is working cooperatively with the USDA and the Arkansas Livestock and Poultry Commission to manage a flock of breeder hens that has been exposed to a low pathogenic strain of avian influenza (LPAI). Preliminary tests on the flock indicate the presence of antibodies for H7N3 avian influenza, however, there is no indication the birds currently have the virus.

The 15,000 chickens involved show no signs of illness and the situation poses no risk to human health.

The affected birds are at the farm of a contract poultry producer in northwest Arkansas. The discovery came as part of routine, pre-slaughter surveillance conducted by the company. The strain involved is low pathogenic H7N3. It is not the highly pathogenic H5N1 virus that has previously affected birds in Asia, Europe and Africa.

Even though the affected birds do not currently have the virus, the flock is being depopulated today as a precautionary measure and will not enter the human food chain. While the birds’ exposure to this strain of avian influenza poses no risk to human health, USDA’s policy is to eradicate all H5 and H7 subtypes.

As a preventative measure, Tyson is also stepping up its surveillance of avian influenza in the area. The company plans to test all breeder farms that serve the local Tyson poultry complex, as well as any farms within a ten mile radius of the affected farm.

The increased surveillance is in addition Tyson’s existing testing program, which involves the company checking all flocks for avian influenza before they leave the farm. The test results are known before the birds are shipped to a Tyson plant for processing.

Contact: Gary Mickelson 479-290-6111

Elderly Population Could Avoid Memory Loss With Active Social Life, Party Time!!

Active Social Life May Delay Memory Loss Among U.S. Elderly Population

Boston, MA -- One of the features of aging is memory loss, which can have devastating effects on the quality of life among older people. In a new study, Harvard School of Public Health (HSPH) researchers found evidence that elderly people in the U.S. who have an active social life may have a slower rate of memory decline. The study appears in the July 2008 issue of the American Journal of Public Health and appears in an advance online edition on May 29, 2008.

"We hope this study adds to and advances our growing understanding of the important role that social forces play in shaping health," said Karen Ertel, postdoctoral fellow in the Department of Society, Human Development and Health at HSPH.

Previous studies have suggested that an active social life may reduce the risk of dementia and cognitive decline among the elderly. Memory loss is a strong risk factor for dementia, a syndrome estimated to affect up to 10% of the U.S. population 65 years and older. The researchers wanted to test whether memory loss might also be associated with social connectedness.

Ertel and her HSPH colleagues, senior author Lisa Berkman, chair of the Department of Society, Human Development and Health, and Maria Glymour, assistant professor, Department of Society, Human Development and Health, used data gathered from 1998 to 2004 from the Health and Retirement Study, a large, nationally representative population of U.S. adults 50 years and older. (Previous studies were conducted outside of the U.S. or using smaller, non-representative population samples.) Memory was assessed in 1998, 2000, 2002 and 2004 by reading a list of ten common nouns to survey respondents, then asking them to recall as many words as possible immediately and after a five-minute delay. Social integration was assessed by marital status, volunteer activities, and contact with parents, children and neighbors.

The results showed that individuals with the highest social integration had the slowest rate of memory decline from 1998 to 2004. In fact, memory decline among the most integrated was less than half the rate among the least integrated. These findings were independent of sociodemographic factors (such as age, gender, and race) and health status in 1998. The researchers found that the protective effect of social integration was largest among individuals with fewer than 12 years of education.

The researchers found no evidence that the results could be due to reverse causation, that is, poor memory or memory decline causing social withdrawal.

"Social participation and integration have profound effects on health and well being of people during their lifetimes," said Berkman. "We know from previous studies that people with many social ties have lower mortality rates. We now have mounting evidence that strong social networks can help to prevent declines in memory. As our society ages and has more and more older people, it will be important to promote their engagement in social and community life to maintain their well being."

Memory loss and dementia pose a major public health burden among the elderly U.S. population. The results suggest that increasing social integration may help slow memory decline among older Americans and could help alleviate the public health burden, particularly because the aging population in the U.S. is expected to increase substantially. "We need to understand more about how social integration reduces the risk of memory decline in order to target interventions that can help slow the decline," said Ertel. "Future research should focus on identifying the specific aspects of social integration most important for preserving memory."

Support for the study was provided by the National Institute of Aging.

"Effects of Social Integration on Preserving Memory Function in a Nationally Representative U.S. Elderly Population," Karen A. Ertel, M. Maria Glymour, Lisa F. Berkman, American Journal of Public Health, July 2008, Vol. 98, No. 7.

For more information, contact:

Todd Datz

617-432-3952

tdatz@hsph.harvard.edu

FDA Warning, New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes, Salmonella Outbreak

FOR IMMEDIATE RELEASE
June 3, 2008

Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes

The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma, or round red tomatoes are the cause. At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, and tomatoes grown at home.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers in New Mexico and Texas who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

From April 23 though June 1, 2008, there have been 57 reported cases of salmonellosis caused by Salmonella Saintpaul in New Mexico and Texas, including 17 hospitalizations. Approximately 30 reports of illness in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas, and Utah are currently being investigated to determine whether they are also linked to tomatoes. There are no reported deaths.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source and type of the contaminated tomatoes. As more information becomes available, FDA will update this warning.

Last year FDA began a multi-year Tomato Safety Initiative to reduce the incidence of tomato-related foodborne illness. The Initiative is a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry.

A key element of the Food Protection Plan -- a scientific and a risk-based approach to strengthen and protect the nation's food supply—is prevention. FDA encourages producers to critically reexamine their operations and apply the scientific principles and regulations established decades ago to provide a safe product for the consumer.

Information on safe handling of produce can be found at www.cfsan.fda.gov/~dms/prodsafe.html.

Tomato consumer page can be found at http://www.fda.gov/oc/opacom/hottopics/tomatoes.html

Updates from the Centers for Disease Control and Prevention can be found at http://www.cdc.gov/

Monday, June 02, 2008

Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

Click On The Image Above To Download A PDF Version Of This Report

Albuterol is a quick-relief medication that's used to open up the airways so that it's easier to breathe. The medication is used by people with certain airway diseases, such as asthma and chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema.

One method of delivering albuterol is the metered dose inhaler, a hand-held device that delivers a specific amount of medication directly into the lungs. Traditionally, inhalers have contained chlorofluorocarbons (CFCs), a type of propellant that helps the albuterol reach the lungs. But inhalers with CFCs are being phased out because they are harmful to the environment.

Here are facts you should know about switching from your CFC-propelled albuterol inhaler to inhalers that contain propellants called hydrofluoroalkanes (HFAs).

CFCs deplete the ozone layer.

CFCs deplete ozone high up in the stratosphere--the part of the earth's atmosphere that protects us from the sun's harmful ultraviolet radiation. In the stratosphere, the ozone layer serves as a shield that absorbs ultraviolet radiation and keeps it from reaching the earth's surface. CFCs are among the substances that damage the ozone layer. This leads to higher levels of ultraviolet B radiation, which has negative effects, including increases in skin cancers and cataracts. Under an international agreement, the United States, along with almost all countries of the world, agreed to phase out CFCs and other ozone-depleting substances.

CFC-propelled albuterol inhalers will no longer be available after Dec. 31, 2008.

In accordance with an FDA Final Rule and under the authority of the Clean Air Act of the U.S. Environmental Protection Agency, no CFC-propelled albuterol inhalers can be produced, marketed, or sold in the United States after Dec. 31, 2008. Manufacturers have been increasing production of HFA-propelled albuterol inhalers so that sufficient supplies exist to replace the CFC-containing inhalers. If you haven't done so already, you should talk with your health care professional about switching to an HFA-propelled albuterol inhaler.

Albuterol inhalers containing HFAs deliver the same medicine, but there are some differences.

The HFA-propelled albuterol inhalers are still convenient and have been shown to be safe and effective in studies with patients. But you may find that the spray from an HFA inhaler tastes and feels different than the spray from the CFC-propelled albuterol inhalers. The spray from an HFA inhaler may feel less forceful, but this does not mean that the medication is not working.

Cleaning and priming your HFA inhaler are especially important.

Cleaning and priming helps prevent medication build-up and blockages, and ensures that the inhaler works properly. Priming an inhaler involves shaking it well and then releasing test sprays into the air. Be sure to hold the inhaler away from your face so that you don't get medication in your eyes. Each inhaler has specific instructions for cleaning and priming that you should follow. Refer to the patient information that accompanies the product.

Four alternative HFA-propelled inhalers are approved by FDA.

There are four products available that can be used to replace your CFC-propelled albuterol inhaler:

  • Proair HFA Inhalation Aerosol (Ivax Corp.)
  • Proventil HFA Inhalation Aerosol (Schering-Plough)
  • Ventolin HFA Inhalation Aerosol (GlaxoSmithKline)
  • Xopenex HFA Inhalation Aerosol (Sepracor)

While they have all been shown to be effective, there are some differences between the products. You may need to talk with your health care professional and try different inhalers to find the product that is right for you.

For More Information

Metered Dose Inhalers (MDIs)
www.fda.gov/cder/mdi/default.htm

FDA Safety Update: Asthma Medications
www.fda.gov/consumer/updates/asthmameds051308.html

FDA's Web Page on Eliminating Ozone-depleting Substances from Metered-Dose Inhalers
www.fda.gov/cder/mdi/albuterol.htm

Pregnancy and Lactation Labeling

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

  • The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
  • Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
  • The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

Switch to HFA-Propelled Albuterol Inhalers Now As CFC-propelled inhalers no longer available as of Dec. 31, 2008, FDA!

FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
CFC-propelled inhalers no longer available as of Dec. 31, 2008

The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.

CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

"Concern about the environment stimulated the need to phase out CFCs," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers."

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

Manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now.

HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.

The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of ozone depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, 2008.

For more information:
http://www.fda.gov/cder/mdi/albuterol.htm

Calcilo XD Infant Formula Recalled Worldwide By Abbott. : Recallr

Abbott today announced a voluntary worldwide recall of two lots of Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD® is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order.

Abbott is voluntarily recalling two lots of product because small amounts of air may have entered the can, resulting in product oxidation. A common sign of oxidation is an off aroma. The problem is isolated to these two lots of Calcilo XD Powder in 14.1-ounce (400g) cans.
Recallr: Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder Recalled Worldwide By Abbott.

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