Lotronex (alosetron hydrochloride) and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea.
Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, FDA has determined the risk evaluation and mitigation strategies (REMS) programs for these drugs are no longer necessary to ensure the benefits outweigh the risks of ischemic colitis and serious complications of constipation.
