The Food and Drug Administration Thursday limited the diabetes drug rosiglitazone (Avandia, Avandamet, and Avandaryl) to people who can't use other medications due to concerns it could cause a heart attack or stroke. The FDA's action falls short of its counterpart across the ocean, the European Medicines Agency, which decided Avandia was too risky and have recommended that it be withdrawn from the market. We have long advised that Avandia carries too many risks and should be avoided if at all possible.
“The evidence we have to date does not support the use of Avandia as a first, second, or even third line drug for treating type 2 diabetes,” according to John Santa, M.D., M.P.H., Director, Consumer Reports Health Ratings Center. “This latest effort on the part of the FDA to deal with a drug that’s unsafe will only confuse consumers. We’ve long advocated for metformin as the safest and most effective option.”
The FDA made its decision in response to earlier studies (see here, here and here for our previous coverage) that show Avandia increases the risk of heart attack and stroke. The agency said that given these risks, people will only be allowed to start on Avandia if other medications fail to keep their blood sugar levels under control and they are unable to take a similar drug to Avandia called pioglitazone (Actos).
People who are already taking Avandia—and that number could be as high as 700,000 according to FDA estimates—will be allowed to continue taking it. The FDA also halted an ongoing clinical trial called “TIDE” that was comparing the heart risks of Avandia to Actos and other diabetes drugs.
In addition to the heart risk, our free Best Buy Drugs report notes that Avandia has also been associated with an increased risk of bone fractures and other concerns. Instead, we recommend the drug metformin, either alone or with glipizide or glimepiride, as your first option. Metformin has a well-established safety profile and it is available as an inexpensive generic.
—Steve Mitchell, associate editor, Consumer Reports Health Best Buy Drugs
Photo: Ian Wilson