FDA to allow GSK’s Avandia, with restrictions

SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.

The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.

The FDA is requiring GSK to develop a restricted access program for the drug under a risk evaluation and mitigation strategy. Under the REMS, Avandia will be available to patients only if they cannot control their glucose levels with Actos (pioglitazone), a drug made by Takeda in the same class as Avandia.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” FDA commissioner Margaret Hamburg said. “We are seeking to strike the right balance to support clinical care.”

Actos has some issues of its own. Last week, the FDA said it would conduct a safety review of the drug after receiving data from a study conducted by Takeda suggesting that some patients taking the drug for the longest periods of time and in the highest dosage could be at risk for bladder cancer. The study did not show an overall association between taking Actos and the risk of bladder cancer, and the FDA said it had not concluded that a risk existed.