BRIEF—FDA eliminates REMS for Lotronex (alosetron hydrochloride)

Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, the US Food and Drug Administration (FDA) has determined the risk evaluation and mitigation strategy (REMS) for the drugs are no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation.

Prescribers can continue to prescribe, and patients can continue to take Lotronex and alosetron hydrochloride as they have been doing.

The Lotronex brand was first approved by the FDA in 2000 as a treatment for irritable bowel syndrome and was developed by Glaxo Wellcome, a legacy company of UK pharma major GSK.