Alosetron for irritable bowel syndrome

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7364.555 (Published 14 September 2002) Cite this as: BMJ 2002;325:555

Some patients may pay a high price for the FDA's decision to put the drug back on the market

  1. Michel Lièvre, associate professor (ml@upcl.univ-lyon1.fr)
  1. Clinical Pharmacology Unit, Faculté de Médecine Laënnec, BP 8071, 69376 Lyons Cedex 08, France

    News p 561Education and debate p 592

    On 9 February 2000 alosetron (marketed as Lotronex by GlaxoSmithKline), a type 3 serotonin (5-HT3) receptor antagonist, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with irritable bowel syndrome, a benig though unpleasant disorder that affects one in five adults in the industrialised world.1 By November 2000, the FDA had received 49 reports of ischaemic colitis and 21 of severe constipation related to the drug, resulting in 44 admissions to hospital, 10 surgical interventions, and 3 deaths.2 The drug was withdrawn from the market by its sponsor. Severe adverse events continued to be reported for some time, with a final total of 84 instances of ischaemic colitis, 113 of severe constipation, 143 admissions to hospital, and 7 deaths.3

    On 7 June 2002, however, the FDA issued a supplemental new drug application that permits marketing of alosetron through a prescribing programme for treating women with irritable bowel syndrome whose main symptom is severe diarrhoea (5% of patients). Doctors will have to sign an attestation of qualification and acceptance of …

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