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Tuesday, 31 July, 2007

Rosiglitazone survives FDA inquest

GlaxoSmithKline’s controversial diabetes drug Avandia (rosiglitazone) will probably stay on the market despite near-unanimous consensus among an FDA drug advisory committee that it poses a cardiac risk.

The committee voted 20 to three yesterday that Avandia indeed boosts myocardial infarction (MI) risk, but voted 22 to one that it should remain on the market. The committee agreed that the product should be accompanied by a “black box” warning.

Drug safety officer and committee member Dr David Graham estimated that the drug may have caused between 66,000 and 200,000 "serious" cardiac problems in patients thus far. But the advisory committee was frustrated by the available data, on which such dour safety estimates are based.

Dr Steven Nissen (left), whose was responsible for kick-starting intense scrutiny of data on Avandia’s adverse effects, responded to the decision:

"I am very satisfied the committee voted to put a strong warning on the drug. This will allow patients and physicians to make decisions based on more information than we had."
It’s likely that the FDA will follow its advisors’ recommendations, . But committee chairman Dr Clifford J Rosen told the New York Times -- it shouldn’t be prescribed to patients with congestive heart failure, a history of cardiovascular disease, or patients taking nitrates or insulin.

For some background, see “” in NRM's current issue.

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