FDA Announces New Restrictions on Rosiglitazone, Europe Suspends the Drug

The FDA has restricted use of the diabetes drug rosiglitazone (Avandia), while the European Medicines Agency has recommended suspending use of the drug entirely over concerns about increased cardiovascular risk.

The FDA says that the manufacturer, GlaxoSmithKline, will develop a risk evaluation and mitigation strategy (REMS) and that access to the drug will be limited to new patients whose diabetes is not controlled by other treatments and who cannot tolerate pioglitazone. Current U.S. users may continue taking rosiglitazone if they appear to benefit and understand the risks.

Simultaneously, the European Medicines Agency recommended suspending sales of rosiglitazone in Europe.

The actions affect Avandia as well as the combination drugs, Avandamet (metformin/rosiglitazone) and Avandaryl (glimepiride/rosiglitazone; marketed as Avaglim in Europe).

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