
New FDA mandates will make it far more difficult for doctors to prescribe the diabetes drug Avandia. Although the European Medicines Agency has suspended European sales of Avandia-containing drugs, the FDA has NOT banned Avandia in the United States. Regulators say the heart attack risks associated with the drug are ju great a safety concern
Avandia will be available to new patients only if they cannot achieve [blood sugar] control on other agents and cannot take Actos," FDA commissioner Margaret A. Hamburg, MD, said at a news conference. "Current patients can continue taking Avandia only if they benefit and understand the risks."
Avandia maker GlaxoSmithKline will be required to establish a Risk Evaluation and Mitigation Strategy (REMS) program. Patients, their doctors, and their pharmacists will have to enroll in the program in order to receive, prescribe, or sell Avandia.
In a statement, GlaxoSmithKline says it "continues to believe that Avandia is an important treatment for patients with type 2 diabetes," but that it will work with the FDA and the European Medicines Agency to implement their decisions.