Market Name: Lotronex

Generic Name: Alosetron HCl

Lotronex is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms lasting six months or longer and have not responded to traditional therapies.

Infrequent but serious gastrointestinal adverse events have been reported with the use of Lotronex. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death. A black box warning was added to Lotronex’s prescribing information by the FDA in February of 2005.

Black Box Warning Date: February 2005

FDA Link: Lotronex