FDA places "black box" warning on antidiabetes drugs

doi:10.1136/bmj.39244.394456.DB

BMJ 2007;334:1237 (16 June), doi:10.1136/bmj.39244.394456.DB

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FDA places "black box" warning on antidiabetes drugs

Janice Hopkins Tanne

New York

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

The US Food and Drug Administration has asked the makers oftwo antidiabetes drugs—rosiglitazone (marketed as Avandia),made by GlaxoSmithKline, and pioglitazone (Actos), made by Takeda—toplace "black box" warnings, the most serious kind, on theirlabels.

The new labels warn of an increased risk of congestive heartfailure, because rosiglitazone and related drugs can cause fluidretention. Andrew von Eschenbach, the FDA's commissioner, announcedthe warning at a hearing of the US House of Representatives'Committee on Oversight and Government Reform last week to examinethe FDA's role in evaluating the safety of rosiglitazone.

The new labels do not address the question of whether thesedrugs pose an increased risk of heart attacks and strokes.

The cardiovascular risk was raised last month by an articleand accompanying editorial in the New England Journal of Medicine(doi: 10.1056/NEJMoa072761). Steven Nissen and Kathy Wolskiof the Cleveland Clinic did a . . . [Full text of this article]

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