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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.


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


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.


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.

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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

Adverse Reactions Linked to Botox

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Medical Device Approvals: Wrinkle Fillers

Laser Facts: Wrinkle Treatment

Your Guide to Reporting Problems to FDA

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
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
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
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
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
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.

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.

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


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.

June 19, 2008

Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:

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

June 18, 2008

Media Inquiries:
Peper Long, 301-827-0599
Consumer Inquiries:

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

June 17, 2008

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

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.

June 16, 2008

Media Inquiries:
Sandy Walsh, 301-827-3418
Consumer Inquiries:

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

FDA Historical Information on Atypical Antipsychotic Drugs


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