DiabetesDrugReport
Your INDEPENDENT source of news about diabetes drugs
 
Diabetic Drug Information
Oral Diabetes Drugs
Drugs for Diabetic Complications

 
 

 

Diabetes Drug Report for July 2007-- News About Diabetes
 
Diabetes Drug Avandia Should Remain on U.S. Market, According to FDA Expert Panel

The widely used diabetes drug Avandia (rosiglitazone) should remain on the U.S. market, independent medical experts near-unanimously concluded July 30th, deciding that evidence of an increased risk of heart attack does not merit withdrawing the drug from sale.

Avandia is the top-selling diabetes drug in the world, and about 1 million Americans with Type 2 diabetes use Avandia to help control blood sugar by increasing the body's sensitivity to insulin.

The members of two FDA advisory panels concluded on an overwhelming 20-to-3 vote that available data shows Avandia increases heart risks for diabetics more than other drugs, and urged that warnings on the diabetes drug's label be strengthened.

Data "does suggest there is an increased risk," said Dr. Clifford Rosen of Bangor, Maine, who chaired the meeting.

But only one member of the FDA's Endocrinologic and Metabolic Drugs advisory committee and the Drug Safety and Risk Management advisory panel voted to pull Avandia from the market. While the FDA does not have to follow recommendations of its advisory panels, a 22-to-1 vote usually carries the day.

Experts on the panels were clearly frustrated by conflicting data presented at the meeting and skeptical of some of the studies showing a link between Avandia and heart disease.

"The quality of the analysis far exceeds the quality of the data," said Nancy Geller, a panel member who is chief of biostatistics research at the National Institutes of Health.

During the meeting, two FDA officials urged the removal of the Avandia from the market, citing concerns that it promotes heart failure among patients with type 2 diabetes.

"Rosiglitazone should be removed from the market," said Dr. David Graham, the FDA's associate director for science and medicine in the office of surveillance and epidemiology. Graham said Avandia is no more effective than a similar drug, Actos, which appears to pose a lesser cardiac risk.

Graham was supported by his boss, Dr. Gerald Dal Pan, who told the experts he also believes Avandia should be taken off the market.

During the daylong meeting, GlaxoSmithKline strongly defended the safety of Avandia, saying that there is no difference in heart-attack rates in patients taking Avandia compared to those taking other diabetes drugs.

Safety questions about Avandia burst into the headlines in May when Cleveland Clinic cardiologist Dr. Steven Nissen published an analysis of 42 relatively short-term studies showing Avandia increased the risk of heart attacks by 43 percent.

 

Diabetes Resources
Privacy Policy | Terms and Disclaimers | About the Diabetes Drug Report
Click to VerifyWe subscribe to the HONcode principles of the HON Foundation.
This is an independent news site reporting on prescription and over-the-counter diabetes drugs and on the many additional diet drugs currently in various stages of development. . Nothing on this site is intended to infringe on any trademarks. Nothing on this site is intended as medical advice. The information provided is for informational purposes only. Always consult a doctor or medical professional with questions regarding a medical condition.

Last Updated: 07/30/2007 Copyright 2004-2006 Medical Week News, Inc. All Rights Reserved