BMJ 2002;325:555-556 ( 14 September )

Editorials

Alosetron for irritable bowel syndrome

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

News p 561 Education and debate p 592

The first 150 words of the full text of this article appear below.

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 benign 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related to the drug, resulting in 44 admissions to hospital, 10 surgical interventions, and 3 deaths.² The drug was withdrawn from the market by its sponsor.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). . . . [Full text of this article]

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• Baker, D. E. (2005). Rationale for using serotonergic agents to treat irritable bowel syndrome. Am J Health Syst Pharm 62: 700-711 [Abstract] [Full text]  
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Rapid Responses:

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Doctors & Patients are Too Stupid?

Verna E. Radcliffe
bmj.com, 15 Sep 2002 [Full text]

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Author's response

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