FDA advisers warn of more deaths if drug is relaunched

doi:10.1136/bmj.325.7364.561

BMJ 2002;325:561 ( 14 September )

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FDA advisers warn of more deaths if drug is relaunched

Ray Moynihan, Washington, DC
The first 150 words of the full text of this article appear below.

Advisers to the US Food and Drug Administration are warning of more serious injuries and drug related deaths if alosetron(Lotronex) $---$ a drug for bowel disorders manufactured by GlaxoSmithKline $---$ returnsto the market later thisyear.

Once considered a potentially top selling drug, it was first approved in February 2000 for women with "diarrhoea- predominant"irritable bowel syndrome. It was withdrawn nine months later afterreports of serious side effects leading to admission to hospital,surgery, anddeath.

Urged by patient groups, the FDA and the manufacturer worked together to bring alosetron back to the market, and in Aprilthis year a special FDA advisory committee meeting recommendedre-approval, based on a "risk management" programme. One of thekey conditions of that programme, debated at the meeting and supportedby a majority of committee members, was that physicians shouldbe specially trained and certified before they could prescribealosetron.

However, when . . . [Full text of this article]

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