Alosetron: Ischemic Colitis and Serious Complications of Constipation
Authors: Gallo-Torres, Hugo1; Brinker, Allen2; Avigan, Mark1
Source: The American Journal of Gastroenterology, Volume 101, Number 5, May 2006 , pp. 1080-1083(4)
Publisher: Blackwell Publishing
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Abstract:
Drugs such as alosetron that modulate serotonin effects by stimulating or blocking its receptors may play an important role in the treatment of some patients with irritable bowel system. In the case of alosetron, a 5HT-3 antagonist, an analysis of data from randomized clinical trials and postmarketing experiences have demonstrated a causal relationship between this drug and ischemic colitis and serious complications of constipation. Because the mechanism(s) of drug-induced ischemic colitis and possibly other forms of intestinal ischemia associated with alosetron have not been elucidated, there is need to further assess risk with regard to patient susceptibility and other factors.(Am J Gastroenterol 2006;101:1080–1083)Document Type: Research article
DOI: 10.1111/j.1572-0241.2006.00650.x
Affiliations: 1: Division of Gastroenterology Products, Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Drug Evaluation III 2: Division of Drug Risk Evaluation, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Safety Silver Spring, Maryland
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