Rosiglitazone Leaves Retail Shelves November 17

Reed Miller

November 17, 2011

November 16, 2011 (Silver Spring, Maryland) — The FDA is reminding patients and doctors that diabetes drugs with rosiglitazone will be available only through certified mail-order pharmacies after November 17. Doctors wishing to prescribe the drugs and patients planning to continue taking them should enroll in GlaxoSmithKline's Avandia Rosiglitazone Medicines Access Program by November 17 [1].

As of November 18, Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride) will no longer be available from retail pharmacies. The FDA is advising patients to ask their doctor whether they should continue taking any of these medications.

As reported by heartwire , in September 2010, the European Medicines Agency suspended marketing of rosiglitazone drugs, and the FDA insisted that GlaxoSmithKline implement a stringent restricted-access program for the drugs after a meta-analysis of 52 studies showed that the drug is associated with a significantly increased risk of MI. The restricted-access program confines rosiglitazone prescriptions to patients who failed to control their blood glucose levels with other drugs and have decided, in consultation with their doctor, not to take pioglitazone (Actos, Takeda Pharmaceuticals).


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