The FDA has determined Risk Evaluation and Mitigation Strategies for the irritable bowel syndrome drug alosetron, originally marketed as Lotronex (Sebela), are no longer necessary to ensure the benefits outweigh the risk for ischemic colitis or other serious complications of constipation.
While safety risks still exist for women with IBS taking the drug, the elimination of the alosetron REMS programs is supported by data, the agency said. Reporting of alosetron-associated adverse events to the