May 22, 2007FDA review confirms Avandia’s heart risks
A safety alert has been issued by the Food and Drug Administration regarding the diabetes drug Avandia, which is made by GlaxoSmithKline. The agency had approved it in 1999 to treat type 2 diabetes, which afflicts 18–20 million Americans.New data suggests that patients using Avandia may be at a significant risk of heart attack or stroke. The FDA urges people taking Avandia to talk to their doctors. Even so, the FDA notes that switching from one diabetes treatment to another can create problems. Thus, physicians and patients should make careful decisions about treatment.
It is well known that diabetics are already at an increased risk of heart disease. Since Avandia has been on the market, the FDA has repeatedly updated its labeling to inform patients about its potential to cause adverse heart-related events (such as congestive heart failure and fluid retention). This, the most recent labeling change, includes a new warning about the heightened risk of heart attack and chest pain and other such Avandia side effects.
According to Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, “The FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened.” GSK has not yet been asked to recall Avandia, but that could change.