Thursday, Dec. 09, 2010

The FDA Restricts Avandia

Eleven years after it hit the market and became a worldwide blockbuster, the diabetes medication Avandia (rosiglitazone) was slapped with the FDA's most stringent drug restrictions yet. Now, the medication that helps control blood sugar in patients with Type II diabetes can be prescribed only by physicians who are part of a registry certifying that they are aware of the increased risk of heart attack associated with the drug. These doctors may dispense Avandia only if their patients have exhausted all other treatment options, and patients must sign off on these risks as well.

The FDA's decision, according to some experts, was long overdue, considering that researchers first reported increased heart risks among Avandia users in 2007. At that time, the FDA instituted its first warning on the drug's label. And yet a government review of the drug's safety revealed that its manufacturer, GlaxoSmithKline, was aware of the heightened risks associated with its product not long after it hit the market in 1999.

The good news for patients who respond well to Avandia but are finding it difficult to keep their prescription filled under the new restrictions is that a similar drug, Actos (pioglitazone), does not seem to pose the same risks to the heart.