FDA places greater restrictions on access to rosiglitazone

BMJ 2010; 341 doi: (Published 24 September 2010) Cite this as: BMJ 2010;341:c5287

The US Food and Drug Administration (FDA) has recommended that an independent review is conducted of key data on the cardiovascular effects of the diabetes drug rosiglitazone to try to determine the drug’s safety along with a package of measures to further restrict its use.

Margaret Hamburg, FDA commissioner, said the agency was “significantly restricting” products containing rosiglitazone because of concerns about cardiovascular safety.

It has asked rosiglitazone manufacturer GSK to submit a “risk evaluation and mitigation strategy”—a step that allows access to the drug under restricted conditions.

Unlike the European Medicines Agency, which announced the suspension of rosiglitazone on 23 September (BMJ 2010;341:c5291, doi:10.1136/bmj.c5291), the US drugs regulator does not have the legal means to suspend a drug, although it did not rule out removing the drug from the market at …

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