The diabetes drug Avandia (rosiglitazone) is to be significantly restricted due to research suggesting it increases the risk of heart attack and stroke.
Avandia is manufactured by GlaxoSmithKline (GSK), in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
It also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
The U.S. Food and Drug Administration will require that GSK develop a restricted access program for Avandia. Under the new rules, 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 so. Doctors will have to confirm their patients’ eligibility and patients will have to acknowledge they understand the cardiovascular safety concerns associated with this drug.