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July 13th, 2005
"FDA advisory committee recommends Serevent, Advair, Foradil remain on market"
An FDA advisory committee unanimously recommended three asthma medications – Serevent, Advair and Foradil – remain on the market, but urged more research to determine whether the medications might worsen asthma in certain patients.
The panel was asked to review the safety of GlaxoSmithKline’s Serevent and Advair and Novartis’ Foradil. The agency received reports of life-threatening respiratory problems and deaths in Serevent users within the first six months of its approval in 1994. In a post- marketing study of Serevent and the final phase of Foradil’s pre-approval studies, a small number of patients experienced severe exacerbations of their asthma.
The Serevent study suggested African-Americans were particularly at risk, and in response to the post-marketing study’s findings, a black box warning was added to Serevent and Advair labels in 2003 – the FDA’s strongest drug warning. Foradil’s label does not contain a comparable black-box warning, which the FDA panel also unanimously recommended be changed to reflect the possible risks.
Last November, FDA whistle-blower David Graham named Serevent as one of five drugs that might end up like the once popular Vioxx drug. Vioxx was a blockbuster arthritis drug that was recalled in September because of potentially fatal cardiovascular safety risks, resulting in thousands of lawsuits and raising serious concerns about how effectively drugs already on the market were being regulated.
An FDA spokeswoman said Graham’s comments about Serevent were not why the agency convened the meeting.
