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Insiders criticise FDA’s decision not to withdraw rosiglitazone

BMJ 2010; 341 doi: (Published 29 September 2010) Cite this as: BMJ 2010;341:c5333
  1. Deborah Cohen
  1. 1BMJ

    The decision of the US Food and Drug Administration to place more restrictions on GlaxoSmithKline’s diabetes drug rosiglitazone (Avandia) rather than withdraw it has drawn criticism from senior officials within the agency.

    In simultaneous statements last week both the FDA and the European Medicines Agency (EMA) suggested that the drug was associated with important safety concerns and that data pointed to a raised risk of cardiovascular events, such as heart attack and stroke, in patients taking rosiglitazone.

    Unlike the EMA—which said that the “benefits of rosiglitazone no longer outweigh its risks” and recommended its suspension from the market in Europe—the FDA has recommended a package of measures to try to determine the safety of the drug and further restrict its use.

    The US drug regulator does not have the legal means to suspend a drug, although it did not rule out removing the drug from the market at a later date. In Europe suspension means that rosiglitazone’s manufacturer, GlaxoSmithKline (GSK), has scope to “provide convincing data” to identify a group of patients in whom the drug’s benefits outweigh the risks.

    The FDA will implement a risk evaluation and mitigation strategy. This will mean that rosiglitazone will be available to new …

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