Further restrictions put on Avandia

WASHINGTON, May 19 (UPI) -- The U.S. Food and Drug Administration is putting further restrictions on the type 2 diabetes drug Avandia, officials say.

The FDA is requiring healthcare providers and patients to enroll in a special program to be able to prescribe and receive drugs containing rosiglitazone -- sold under the names Avandia, Avandamet and Avandaryl.

The restrictions are based on data that suggest patients treated with rosiglitazone have higher levels of heart attacks than others. The FDA restricted the use of rosiglitazone eight months ago to patients for whom other medications did not work.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia, but it is also sold as a combination product under the brand name Avandamet -- containing rosiglitazone and metformin -- and under the brand name Avandaryl -- containing rosiglitazone and glimepiride, FDA officials say.

Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program to be able to prescribe and receive rosiglitazone medicines.

Rosiglitazone medicines will no longer be available through retail pharmacies after Nov. 18, but patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program, the FDA says.