Alosetron was approved in 2000 for use in women with diarrhea-predominant irritable bowel syndrome (IBS-D), however infrequent serious adverse events (including ischemic colitis and serious complications of constipation, resulting in hospitalization, blood transfusion, surgery and death) prompted alosetron's voluntary withdrawal from the US market in November 2000. Public request prompted its reintroduction in 2002 under a Risk Management Plan, including a more restricted indication and a Prescribing Program for Lotronex.
Only licensed for use in female patients.
Contra-indicated in patients with constipation or a history of chronic or severe constipation or sequelae from constipation; intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; ischemic colitis; impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; Crohn’s disease or ulcerative colitis; diverticulitis; severe hepatic impairment.
- TRADE NAME: Lotronex (GSK)
- INDICATIONS: Irritable bowel syndrome
- CLASS: 5-HT3 antagonist, Serotonin type 3 receptor antagonist
- HALF-LIFE: 1.5 hours
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
Apomorphine, Conivaptan, CYP1A2 inhibitors, CYP3A4 inhibitors, Darunavir, Delavirdine, Eluxadoline, Fluvoxamine, Indinavir, Telithromycin, Teriflunomide, Viloxazine, Voriconazole
SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
See full prescribing information for complete boxed warning.
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Page last updated 07/31/2023
