Navigation Links
FDA to Pull Diabetes Drug Avandia From Pharmacy Shelves
Date:5/19/2011

By Steven Reinberg
HealthDay Reporter

THURSDAY, May 19 (HealthDay News) -- The U.S. Food and Drug Administration has announced that the controversial diabetes drug Avandia will no longer be sold at retail pharmacies beginning this November, due to the cardiovascular risks it poses to patients.

According to the new rules, which will go into effect on Nov. 18, the medication will only be available to patients who've been safely using the drug, those who have had no success in controlling their blood sugar with other diabetes medications or patients who have been informed of the risks and still choose to take Avandia (rosiglitazone).

These patients must be enrolled in a special program to qualify to receive the drug, according to the FDA.

"Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program," the agency said in a statement released Wednesday. "The drug manufacturer, GlaxoSmithKline, will withdraw rosiglitazone medicines from the current supply chain and will provide pharmacies with instructions on returning the medicines."

Rosiglitazone is also sold under the names Avandamet (where the drug is combined with metformin) and Avandaryl (rosiglitazone plus glimeperide). The new rules apply to those combination drugs as well.

According to Bloomberg News, GlaxoSmithKline said it plans to inform pharmacists and doctors about the new access program over the next two months, company spokeswoman Mary Anne Rhyne said. In the meantime, patients should discuss their options with their doctors before making any changes to their diabetes treatment.

The withdrawal of Avandia and related products from drugstore shelves comes eight months after the FDA severely restricted use of rosiglitazone to those patients with type 2 diabetes for whom other medications do not work.

"It's like a decade-long nightmare coming to an end," Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, told USA Today. "Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."

Nissen has long urged the action taken by the FDA this week. He led a study, published in 2007, that found that people with type 2 diabetes who took the drug had a 40 percent increase in heart attack risk. That increase in risk was supported in subsequent trials.

More than 23 million Americans are thought to have type 2 diabetes and, according to the FDA, almost a half-million Americans filled a prescription for rosiglitazone in the first 10 months of 2010. That number has since been on the decline, however, the agency added.

In fact, the new decision "reflects the declining number of physicians and patients who are willing to use the medication in clinical practice," said Dr. Ronald Tamler, assistant professor of medicine and clinical trials leader at the Mount Sinai Diabetes Center in New York City. "Those patients that are still taking the medication can be reevaluated by a certified prescriber or may be transitioned to a safe, efficacious alternative," he said.

As part of restrictions put in place by the FDA back in September, doctors have had to state and document a patient's eligibility to use Avandia. They also have to tell patients about the cardiovascular safety risks associated with Avandia, and patients have to acknowledge that they understand those risks.

In Europe, the European Medicines Agency last year suspended marketing of the drug, forcing patients to find other medications to control their blood sugar levels.

Rosiglitazone belongs to a class of drugs known as thiazolidinediones. It is intended to be used along with diet and exercise to control blood sugar levels in patients with type 2 diabetes.

The latest FDA action does not affect the other major thiazolidinedione, Actos (pioglitazone), made by Takeda Pharmaceuticals. That drug has not shown the heart risks seen in the Avandia trials.

Speaking at the time of the FDA's action back in September, Dr. Ronald Goldberg, a professor at the Diabetes Research Institute of the University of Miami Miller School of Medicine, saw little use for Avandia. Since a similar, safer alternative -- Actos -- exists, "you would think there would be very little place for Avandia," he said at the time.

Goldberg also said he would no longer prescribe Avandia, except to patients who have been using it for many years.

More information

For more information on diabetes, visit the U.S. National Library of Medicine.

SOURCES: Ronald Goldberg, M.D., professor, Diabetes Research Institute, University of Miami Miller School of Medicine; Sept. 23, 2010; Ronald Tamler, M.D., Ph.D., assistant professor, medicine and clinical trials leader, Mount Sinai Diabetes Center, New York City; May 18, 2010, USA Today, Bloomberg


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Breakthrough medical food reverses risk of heart disease and diabetes
2. Fat Cats, Dogs Developing Diabetes, Report Finds
3. Fever During Pregnancy, Diabetes and Obesity May Raise Autism Risk
4. Poor Sleep Might Worsen Diabetes
5. Diabetes in Kids Comes With Hefty Price Tag
6. Multiple Pregnancies May Up Risk of Obesity, Diabetes: Animal Study
7. New frontiers in diabetes: The oral health connection
8. New Clues to How Gastric Bypass Surgery Combats Diabetes
9. Protein levels could signal that a child will develop diabetes
10. Treat Depression to Boost Diabetes Self-Care: Study
11. Do Immune System Ills Help Drive Type 2 Diabetes?
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA to Pull Diabetes Drug Avandia From Pharmacy Shelves
(Date:12/8/2016)... ... 2016 , ... David J. Dykeman , Ginger Pigott , and ... speak at DeviceTalks West, Dec. 12, 2016, at the Fairmont Newport Beach in California. ... firm’s global Life Sciences & Medical Technology Group have been featured speakers at every ...
(Date:12/8/2016)... Tampa, Fla (PRWEB) , ... December 08, 2016 ... ... offering smarter modes of access for customers and employees that are both engaging ... ChangeGear 7 with Service Smart Technology, the software company revealed today its plans ...
(Date:12/8/2016)... ... 2016 , ... Catalent Pharma Solutions, the leading global provider ... products, today announced that it had joined the Pharmaceutical Supply Chain Initiative (PSCI). ... unite pharmaceutical and healthcare companies that share a vision of better, social, environmental ...
(Date:12/8/2016)... ... December 08, 2016 , ... STAT courier is pleased ... a convenient service for Texas, they are expanding their presence in Dallas. One of ... spree that will bring new jobs to the Dallas and Forth Worth market. STAT ...
(Date:12/8/2016)... ... December 08, 2016 , ... Today’s patients are encouraged to ... mind, SIGVARIS has created a new line of anti-embolism stockings to help prevent ... the benefits of graduated compression when transitioning from recovery to early rehabilitation. , ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... AMSTERDAM , December 8, 2016 Information ... TM metrics in Scopus , the world,s largest ... free access to comprehensive metrics for journals from over 5,000 publishers. ... publish, which journals to subscribe to and when to adjust a ... , , ...
(Date:12/8/2016)... 2016 According to the research report, ... is expected to be worth US$9.7 bn by the ... Between the forecast years of 2016 and 2024, the global ... The leading players operating in the global diabetes injection pens ... plc., Biocon Ltd., and Sanofi S.A. Transparency Market Research reports ...
(Date:12/8/2016)... 2016 According to a new market research report ... Therapeutic (Pain, Insulin)), End Use (Sports, Fitness, RPM), Type (Smart watch, Patch), ... global market, in terms of value, is projected to reach 12.14 Billion ... 18.0% during the forecast period. Continue Reading ... ...
Breaking Medicine Technology: