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FDA advisers warn of more deaths if drug is relaunched

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7364.561 (Published 14 September 2002) Cite this as: BMJ 2002;325:561
  1. Ray Moynihan
  1. Washington, DC

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 It was withdrawn nine months later after reports of serious side effects leading to admission to hospital, surgery, and death.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

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