Alosetron for irritable bowel syndrome

摘要

On 9 February 2000 alosetron (marketed as Lotronex by GlaxoSmithKline), a type 3 serotonin (5-HT_3) 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. 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. The drug was withdrawn from the market by its sponsor.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.