Diabetes Drug Avandia Now Under Harsher FDA Restrictions
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.
