FDA Restricts Access to the Diabetes Drug Avandia

The FDA announced that it will significantly restrict the use of the diabetes drug, Avandia (rosiglitazone), to patients with type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke in patients treated with rosiglitazone. Rosiglitazone also is available in combination with other diabetes medications, such as metformin under the brand name Avandamet, or glimepiride under the brand name Avandaryl. The FDA will require that the manufacturer of Avandia develop a REMS (risk evaluation and mitigation strategy) restricted access program for the drug. Under this program, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do. See the FDA drug safety annoucement..