BMJ 2002;325:561 ( 14 September )

News

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---returns to the market later this year.

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 It was withdrawn nine months later after reports of serious side effects leading to admission to hospital, surgery, and death.

Urged by patient groups, the FDA and the manufacturer worked together to bring alosetron back to the market, and in April this year a special FDA advisory committee meeting recommended re-approval, based on a "risk management" programme. One of the key conditions of that programme, debated at the meeting and supported by a majority of committee members, was that physicians should be specially trained and certified before they could prescribe alosetron.

However, when . . . [Full text of this article]
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This article has been cited by other articles:

  • Moynihan, R. (2002). Alosetron: a case study in regulatory capture, or a victory for patients' rights?. BMJ 325: 592-595 [Full text]  

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Relationships?
Verna E. Radcliffe
bmj.com, 15 Sep 2002 [Full text]
More Doctor education,not deaths.
Donna M Logan
bmj.com, 16 Sep 2002 [Full text]
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