FDA committees say keep rosiglitazone available but increase warnings

doi:10.1136/bmj.39294.417442.DB

BMJ 2007;335:223 (4 August), doi:10.1136/bmj.39294.417442.DB

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FDA committees say keep rosiglitazone available but increase warnings

Janice Hopkins Tanne

New York

The first 150 words of the full text of this article appear below.

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

Warnings will be increased, however, about use in subgroupsof patients. Whether the warnings will be of the most serious"black box" type is yet to be determined. The FDA usually followsthe advice of advisory committees but is not required to. TheFDA will consider the committees' discussion and make recommendationsfor changes to labelling.

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

The FDA brought forwards its meeting to consider rosiglitazone'srisks in light of a paper by researchers . . . [Full text of this article]

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