/* mobile /* end mobile MEDDESKTOP: July 2009

Friday, July 31, 2009

FDA Issues Draft Guidelines To Eliminate Microbial Contamination In Tomatoes, Leafy Greens, And Melons.

The U.S. Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and melons.

The guidances are, in part, based on those originally developed by the produce industry with assistance from FDA. They represent the first step in a fundamental shift in strategy for the agency in the prevention of foodborne hazards associated with fresh fruits and vegetables.

“These guidances embody the Obama Administration’s and FDA’s prevention-oriented food safety strategy,” said FDA Commissioner Margaret A. Hamburg, M.D. “They will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

These commodity-specific guidances were called for by the President’s Food Safety Working Group, which recommends a new, public-health focused approach to food safety. In a report issued earlier this month, the working group made recommendations aimed at creating a stronger food safety system. The recommendations stem from three core food safety principles:

  • Prevent harm to consumers
  • Use good data and analysis to ensure effective food safety inspections and enforcement of the law
  • Identify outbreaks of foodborne illness quickly and stop them

Key elements of the draft guidances related to the working group’s strategies include:

  • An acceptable baseline standard of industry practices that help both domestic and foreign firms minimize the risk for microbial contamination of their products throughout the entire supply chain
  • Recommendations regarding growing, harvesting, packing, processing, transportation, and distribution of the product
  • Recommendations for recordkeeping, including some that will help the FDA determine more quickly the source of outbreaks that do occur.

Comments on FDA’s guidance documents may be submitted at any time. However, to ensure that comments are received in time for consideration in drafting final versions of these guidance documents, written or electronic comments should be submitted within 90 days of publication in the Federal Register. See http://www.regulations.gov for information.

Onglyza (saxagliptin), New Drug To Treat Type 2 Diabetes, Approved By FDA

For Immediate Release: July 31, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Thursday, July 30, 2009

Abbott Vascular Recalls POWERSAIL® Coronary Dilatation Catheters.

Abbott Vascular has recalled three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.
Recallr: Abbott Recalls POWERSAIL® Coronary Dilatation Catheters
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Wednesday, July 29, 2009

Guidance for Industry, Drug-Induced Liver Injury

FDA has released a guidance to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug or a product to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

This evaluation is important because most drugs that cause severe DILI do so infrequently; typical drug development databases with up to a few thousand subjects exposed to a new drug will not show any cases. Databases may, however, show evidence or signals of a drug’s potential for severe DILI if the clinical and laboratory data are properly evaluated for evidence of lesser injury that may not be severe, but may predict the ability to cause more severe injuries. This guidance describes an approach that can be used to distinguish signals of DILI that identify drugs likely to cause severe liver injury from signals that do not suggest such a potential. This guidance does not address issues of preclinical evaluation for signals of DILI, nor the detection and assessment of DILI after drug approval and marketing.
The guidance is available from FDA.
Follow the link below for a PDF file;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

New Abd Genetic Drug Approvals By FDA (July 28th 2009)

After being absent for a while, new and generic drug approvals by FDA will be listed again.

Following Drugs were Approved by FDA on July 28, 2009

Electronic Cigarettes (e-Cigarettes) Could Increase Nicotine Addiction, FDA Warns

Image From Wikipedia

If you are a smoker, please just stop! You can get help at Smokefree.Gov

FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

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For More Information
Electronic Cigarettes

National Institutes of Health Stops Viagra Trial

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns. In an interim review of safety data from 33 participants who completed 16 weeks of treatment, researchers found that, compared to participants on placebo (dummy pill), participants taking sildenafil (Revatio) were significantly more likely to have serious medical problems. The most common problem was episodes of severe pain called sickle cell crises, which resulted in hospitalization. No deaths have been associated with the drug in the clinical trial.

Known as walk-PHaSST, the study was the first multicenter, randomized clinical trial to test the safety and effectiveness of sildenafil for pulmonary hypertension in patients with sickle cell disease, one of the most common genetic blood disorders in the United States. Pulmonary hypertension is a debilitating condition of high blood pressure in the arteries that carry blood to the lungs, which can lead to heart failure and death. Approximately 30 percent of sickle cell disease patients develop pulmonary hypertension, and even mild levels of pulmonary hypertension have been associated with sudden death in people with sickle cell disease.

"The increase in sickle cell medical problems is concern enough for us to stop this clinical trial to protect the safety of our participants," said NHLBI Director Elizabeth G. Nabel, M.D. "We will continue to look into the possible causes of these preliminary results. In the meantime, we encourage patients with sickle cell disease who are taking sildenafil for pulmonary hypertension to talk with their physicians about the potential risks and benefits of the medication and what actions they should consider, including whether to taper off this medication and how to best manage both sickle cell disease and pulmonary hypertension."

Because the medical problems experienced in walk-PHaSST were complications specific to sickle cell disease, "The findings of the walk-PHaSST study should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective," Nabel added.

Researchers are conducting extensive analyses of the study results, which could contribute to recommendations for treating pulmonary hypertension in patients with sickle cell disease. They will prepare reports of their research for publication in peer-reviewed journals.

Walk PHaSST was conducted at the following locations:

  • Children's Hospital, Oakland, Calif.
  • University of Colorado, Denver
  • Howard University Hospital, Washington, D.C.
  • University of Illinois at Chicago
  • Johns Hopkins Medical Institutions, Baltimore
  • NIH Clinical Center, Bethesda, Md.
  • Albert Einstein College of Medicine, New York City
  • Columbia University, New York City
  • Children's Hospital, Pittsburgh
  • Imperial College London and Hammersmith Hospital, London, England

Rho Inc. of Chapel Hill, N.C., serves as the data coordinating center. Pfizer provided the treatment drug and placebo for the study.

NHI

FDA Warns Against Body-building Supplements Claiming To Be Steroids


The FDA is notifying the public about new safety information concerning products marketed for body building and increasing muscle mass. The FDA has sent a Warning Letter to a manufacturer of body building supplements that claim to contain steroid-like ingredients, but in fact contain synthetic steroids. The products named in the Warning Letter are marketed by American Cellular Laboratories, Inc., and include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme.”

The FDA has received reports of serious adverse events associated with the use of these products and other similar products. Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores. They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung).

Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine. The FDA also recommends that consumers talk with their health care professional about any body building supplements they are taking or planning to take, particularly if they are uncertain about a product’s ingredients.

Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements. Additionally, health care professionals should be alert to patients presenting with the warning signs that may be associated with the use of steroids or steroid-like substances, including liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.

Health care professionals and consumers are encouraged to report any adverse events related to the use of these products to FDA's MedWatch Adverse Event Reporting program, either online, by regular mail or by fax, using the contact information at the bottom of this page.

For more details about these products see FDA’s Consumer Information piece (Consumer Update)Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.

Tanning Beds, As Dangerous As Arsanic And Cigarettes.

An IARC Working Group has classified UV-emitting tanning devices as “carcinogenic to humans” (Group 1). The Working Group was convened by the IARC Monographs programme and the conclusions are reported in an article and press release issued today by The Lancet Oncology .

Combined analysis of over 20 epidemiological studies shows that the risk of cutaneous melanoma is increased by 75% when the use of tanning devices starts before age 30. There is also sufficient evidence of an increased risk of ocular melanoma associated with the use of tanning devices. Studies in experimental animals support these conclusions and demonstrate that ultraviolet radiation (UVA, UVB, and UVC) is carcinogenic to humans.

These findings reinforce current recommendations by the World Health Organization to avoid sunlamps and tanning parlours and to protect yourself from overexposure to the sun.

Further information can be found in the 2006 report of an earlier IARC Working Group and from WHO's website at http://www.who.int/mediacentre/factsheets/fs287/en/.

HealthCare Insurance Reform, What You Stand To Gain!

  • No Discrimination for Pre-Existing Conditions
  • Insurance companies will be prohibited from refusing you coverage because of your medical history.
  • No Exorbitant Out-of-Pocket Expenses, Deductibles or Co-Pays
  • Insurance companies will have to abide by yearly caps on how much they can charge for out-of-pocket expenses.
  • No Cost-Sharing for Preventive Care
  • Insurance companies must fully cover, without charge, regular checkups and tests that help you prevent illness, such as mammograms or eye and foot exams for diabetics.
  • No Dropping of Coverage for Seriously Ill
  • Insurance companies will be prohibited from dropping or watering down insurance coverage for those who become seriously ill.
  • No Gender Discrimination
  • Insurance companies will be prohibited from charging you more because of your gender.
  • No Annual or Lifetime Caps on Coverage
  • Insurance companies will be prevented from placing annual or lifetime caps on the coverage you receive.
  • Extended Coverage for Young Adults
  • Children would continue to be eligible for family coverage through the age of 26.
  • Guaranteed Insurance Renewal
  • Insurance companies will be required to renew any policy as long as the policyholder pays their premium in full. Insurance companies won't be allowed to refuse renewal because someone became sick.
Thank you President Obama!

Thursday, July 09, 2009

Summer, Barbecuing, And Food Safety


We all love to have a barbecue in this nice and warm sunny days of summer. What a better way to enjoy a day with friends and family. Usually these are the occasions that brings families together and rekindle family ties and friendships.
So you certainly do not want to get sick or make anyone sick during these happy occasions and I found this great and siple guide lines to having a super and safe barbecues and family outings at health Canada site. (link at the end of the article). Have a great summer and many a barbecues!

At the store

When you're at the grocery store, buy cold food at the end of your shopping. Make sure to keep raw meat separate from other products. You can put packages of raw meat in separate plastic bags to keep meat juices from leaking onto other foods. This helps avoid possible cross-contamination and prevents the spread of foodborne illness. Always refrigerate perishable foods within one to two hours, especially in warm weather.

Storing raw meat

In the refrigerator

At home, store raw meat in the refrigerator immediately after you return from the grocery store. Freeze raw poultry or ground beef that won't be used within one to two days. Freeze other meats within four to five days.

Marinate meat in the refrigerator, not on the counter. Remember to set some marinade aside in the fridge if you want to use it later to baste meat or use it as a dipping sauce. Do not use leftover marinade from the raw food on the cooked food.

In the cooler

If you are storing your meat in a cooler before barbecuing, make sure that the cooler is kept cold with ice packs. Keep the cooler out of direct sunlight and avoid opening it too often, because it lets cold air out and warm air in. You may also want to use two coolers, one for drinks (as it may get opened more often) and another one for food.

Whether you are storing the meat in the refrigerator or a cooler, always remember to keep food out of the temperature danger zone of 4°C to 60°C (40°F to 140°F). Bacteria can grow in this temperature range. After only two hours in this range, your food can become dangerous.

Cross-contamination

To avoid potential cross-contamination and the spread of foodborne illness, follow the following steps:

  • Make sure to keep raw meat away from other foods, including vegetables such as lettuce and tomatoes. You can do this by packing meats separately or by making sure they are wrapped separately, so that juices don't leak out onto other foods.
  • Wash your hands carefully with soap and warm water for at least 15- 20 seconds before and after handling raw meat.
  • Clean all your cooking equipment, utensils and work surfaces, and then sanitize them with a mild bleach solution, in the following manner:
    • Combine 5 mL (1 tsp) of bleach with 750 mL (3 cups) of water in a labelled spray bottle.
    • Spray the bleach solution on the surface/utensil and let stand briefly.
    • Rinse with lots of clean water and air dry (or use clean towels).

Thawing

Thawing should be done in the refrigerator. Sealed packages can be thawed in cold water. Microwave defrosting is acceptable if the food item is placed immediately on the grill. Meat should be completely thawed before grilling so that it cooks more evenly.

Cook thoroughly and use a digital food thermometer

Bacteria such as E. coli , Salmonella and Listeria can only be killed by heat. Raw meat must be cooked properly to a safe internal temperature (see chart below) to avoid foodborne illness. Colour alone is not a reliable indicator that meat is safe to eat. Meat can turn brown before all the bacteria are killed, so use a digital food thermometer to be sure.

To check the temperature of meat that you are cooking on the barbecue, take it off the grill and place it in a clean plate. Insert the digital food thermometer through the thickest part of the meat. For hamburgers, you should insert the digital food thermometer through the side of the patty, all the way to the middle. Make sure to check each piece of meat or patty because heat can be uneven.

Do not use the same plate or utensils for raw and cooked meat because cross-contamination can occur. Raw juices can spread bacteria to your safely-cooked food and cause foodborne illness.

Remember to always clean your digital food thermometer in warm, soapy water between temperature readings to avoid cross-contamination.

Internal Cooking Temperatures

You can't tell by looking. Use a digital food thermometer to be sure!

Food Temperature
Beef, veal and lamb (pieces and whole cuts)

  • Medium-rare
  • Medium
  • Well done


  • 63°C (145°F)
  • 71°C (160°F)
  • 77°C (170°F)
Pork (pieces and whole cuts)
  • 71°C (160°F)
Poultry (e.g. chicken, turkey, duck)

  • Pieces
  • Whole


  • 74°C (165°F)
  • 85°C (185°F)
Ground meat and meat mixtures
(e.g. burgers, sausages, meatballs, meatloaf, casseroles)

  • Beef, veal, lamb and pork
  • Poultry



  • 71°C (160°F)
  • 74°C (165°F)
Egg dishes
  • 74°C (165°F)
Others
(e.g. hot dogs, stuffing, leftovers)

  • 74°C (165°F)

Keep hot food hot

Remember to keep hot food hot until served. Keep cooked meats hot by setting them to the side of the grill, not directly over coals where they can overcook.

Serving food

Use a clean plate when taking food off the grill. Remember not to put cooked food on the same plate that held raw meat. This prevents it from being re-contaminated by raw juices.

Leftovers

Cool food by using shallow containers, so that it cools quickly. Discard any food left out for more than two hours. On hot summer days, don't keep food at room temperature for more than one hour. Remember to keep food out of the temperature danger zone of 4°C to 60°C (40°F to 140°F). When in doubt, throw it out!

For more information on food safety, please visit Health Canada's website,

Wednesday, July 01, 2009

Chantix (varenicline) and Zyban (buproprion) Label Change Required To Indicate Serious Mental Health Events.

FDA earlier in may 2008 approved a label change for smoking cessation aid, Chantix but now have released another request for label change. This time it has added Zyban to the list as well. The labeling approval came after an Advisory on Chantix by FDA, which was issued in February 2008.

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

For Immediate Release: July 1, 2009

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking.
In addition to the Boxed Warning, the FDA also is requesting more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using these products.

Manufacturers also will be required to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders. The FDA’s review of adverse events for patients using nicotine patches did not identify a clear link between those medications and suicidal events.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

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