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Lotronex (Alosetron) & Ischemic Colitis

    Basic Details
    Last Updated
    Monday, March 4, 2024
    Original Posting Date
    Health Outcome(s)
    ischemic colitis
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Alosetron (brand name Lotronex) is approved for the treatment of women with severe diarrhea-predominant irritable bowel syndrome (IBS-D). U.S. Prescribing Information for alosetron presents a boxed warning for serious gastrointestinal adverse reactions, including ischemic colitis. In addition, the Food and Drug Administration (FDA) required a Risk Evaluation and Mitigation Strategy (REMS) program for Lotronex and approved generics to mitigate the risks of ischemic colitis and serious complications of constipation.

    To support an evaluation of the REMS programs for Lotronex and alosetron, FDA conducted an analysis in the Sentinel System to provide contemporary estimates of the incidence of ischemic colitis during alosetron use. Among women without pre-index intestinal ischemia, the incidence of ischemic colitis was estimated to be 3.08 (95% confidence interval, 1.80-5.26) per 1,000 in the first six months after a new pharmacy dispensing for alosetron. The estimated rate of ischemic colitis was consistent with that described in the alosetron Prescribing Information. These data supported FDA’s decision to eliminate the Lotronex and alosetron REMS programs.