FDA sets new Avandia limits: Latest in series of restrictions on diabetes drugs linked to heart risks

By Kimberly Atkins

The Daily Record Newswire

The Food and Drug Administration has set new restrictions on the distribution and use of controversial diabetes drugs Avandia, Avandamet and Avandaryl, which have been linked to a higher risk of heart attacks.

Under the new rules, the medications will not be available through retail pharmacies after Nov. 18.

Health care providers and patients must enroll in a special program in order to prescribe and receive these drugs under the rules.

Patients enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.

In September 2010, the FDA imposed tight restrictions on the drug, requiring its manufacturer, GlaxoSmithKline, to make it available to new patients only if they are unable to control their Type 2 diabetes with other drugs and if they are made aware of the serious potential heart risks associated with the drug.

Patients who were taking the drug at the time were allowed continue to do so if they chose.

In February of this year, the company announced that it would put a new warning label, which would provide information about heightened FDA restrictions on Avandia and warn of potential heart failure linked to the drug.

Since then, thousands of suits involving Avandia and related diabetes drugs have been settled, and the company has reportedly set aside more than $6 billion for future settlements.

Published: Thu, May 26, 2011