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FDA committees say keep rosiglitazone available but increase warnings

BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39294.417442.DB (Published 02 August 2007) Cite this as: BMJ 2007;335:223
  1. Janice Hopkins Tanne
  1. New York

    Two Food and Drug Administration advisory committees recommended this week that the FDA should keep rosiglitazone (Avandia), which is used to treat type 2 diabetes, on the market, despite concerns about the raised risk of heart attack in some patients.

    Warnings will be increased, however, about use in subgroups of patients. Whether the warnings will be of the most serious “black box” type is yet to be determined. The FDA usually follows the advice of advisory committees but is not required to. The FDA will consider the committees' discussion and make recommendations for changes to labelling.

    The FDA's advisory committees on endocrinological and metabolic drugs and the drug safety and risk management advisory committees met jointly at a crowded public meeting in a hotel near the FDA headquarters, outside Washington, DC, on Monday.

    The FDA brought forwards its meeting to consider rosiglitazone's risks in light of a paper by researchers at the Cleveland Clinic that showed …

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