FDA drops REMS requirement for alosetron (Lotronex)

Although safety risks for alosetron hydrochloride (Lotronex) 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 risks of ischemic colitis and serious complications of constipation. Info about ischemic colitis, serious complications of constipation, and mitigation of these risks will remain in the prescribing information, including the existing Boxed Warning, and the Medication Guide. Tap for more info for clinicians and patients ...