Alosetron - New Drug for Irritable Bowel

Alosetron (Lotronex) was approved for marketing by the FDA in February, 2000, but was withdrawn from the market in November, 2000, because of serious, life-threatening, gastrointestinal side effects. In June 2002, it was approved again by the FDA for marketing but in a restricted manner as part of a drug company-sponsored program for managing the risks associated with treatment. Use of alosetron is allowed only among women with severe, diarrhea-predominant, irritable bowel syndrome (IBS) who have failed to respond to conventional treatment for IBS.

This article was written at the time of the first FDA approval.

--Medical Editors,

Irritable Bowel Syndrome (IBS) is a complex gastrointestinal disorder of unknown cause that afflicts approximately one out of every five adult Americans and three times as many women as men. The symptoms of IBS include abdominal pain, bloating, mucous in stools, and diarrhea and/or constipation. Commonly, more than one symptom is present. Psychological features such as depression, anxiety or stress may accompany IBS. There are no tests for IBS. In fact, the diagnosis of IBS is based on the presence of compatible symptoms and normal tests for gastrointestinal disorders (for example, x-rays and endoscopic examination of the intestines). It is theorized that the cause of IBS is dysfunction of intestinal nerves and/or muscles.

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