Experts advise against using diabetes drug Avandia
A panel of experts convened by the American Diabetes Association and the European Association for the Study of Diabetes has “unanimously advised against using” the diabetes drug Avandia.
The recommendation appears in updated guidelines which have been published online and will be appear in print in the journal Diabetes Care in its January 2009 issue.
Avandia, whose chemical name is rosiglitazone maleate, is used to treat type 2 diabetes but has been linked to an increased risk of heart attacks and other cardiovascular problems.
The drug is also marketed under the names Avandamet and Avandaryl.
The panel said that while studies linking the drug to heart attacks and other cardiovascular complications are not “conclusive” the fact that there are other effective treatment options led to the unanimous decision to advise against the drug’s use.
In related news, the consumer watchdog group Public Citizen has filed a petition with the U.S. Food and Drug Administration (FDA) calling on the agency to ban the drug.
In addition to concerns about cardiovascular complications, the group alleges that Avandia has been linked to 14 cases of liver failure.
Our petition is based on rosiglitazone’s multiple, serious risks, including one just documented by our new analysis of 14 cases of liver failure, of which 12 resulted in death. In addition there is clear previous evidence of increased risk of heart attacks, heart failure, bone fractures, anemia and macular (retinal) edema with vision loss. The evidence for this unique combination of toxicities is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for diabetes, such as metformin, insulin and sulfonylureas.
To learn more:
- Read the National Library of Medicine’s information page on rosiglitazone (Avandia), which includes information about its uses and side effects.
- Read the guidelines from the American Diabetes Association and the European Association for the Study of Diabetes. (The warning on Avandia appears at the bottom of the first column on page 5.)
- Read Public Citizen’s letter to the FDA calling for a ban on Avandia.
- Visit the website of Avandia’s manufacturer, GlaxoSmithKline
Other resources for information about diabetes:
- Visit website of the American Diabetes Association: www.diabetes.org
- Juvenile Diabetes Research Foundation Northwest Chapter: www.jdrfnorthwest.org
On Thursday, the consumer group Public Citizen asked the U.S. Food and Drug Administration to ban the drug. Public Citizen said that in addition to the risk of heart attack, which is already cited in a “black box” warning on the drug’s label, it identified 14 cases of Avandia-induced liver failure. The group said that a review of adverse-event reports filed with the FDA indicated that 12 of the 14 cases resulted in liver-related deaths.
Category: Diabetes, Drugs & Medicines, Metabolic Health
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