May 19, 2011

Avandia: FDA Puts End to a Drug Problem (Almost)

The rumors of Avandia's total removal from the retail market became a reality this week, when the U.S. Food and Drug Administration (FDA) announced that starting in November, the once-popular type 2 diabetes drug will no longer be available to almost all patients.

Avandia (or rosiglitazone maleate), manufactured by GlaxoSmithKline, earned FDA approval in 1999. Since then, it's been a popular prescription option for controlling blood sugar in adults with type 2 diabetes.

But Avandia has also been linked to an increased risk of heart attack since 2007, and the FDA hasn't been shy about limiting sales of the drug since that time. Avandia's complete removal from the market became a distinct possibility in September 2010, when the FDA ordered severe restrictions on the drug.

This week's action doesn't amount to a complete FDA recall of Avandia, but it's about as close as it gets. According to the FDA's announcement, after November 18, 2011 Avandia (and its companion rosiglitazone medicines Avandamet and Avandaryl) will no longer be available through retail pharmacies. Only a very limited number of patients will still be able to receive these drugs, and they must be enrolled in a special program before they'll receive the medicine via mail order, from specially-certified pharmacies.