What is the role of alosetron in IBS?
Although alosetron was approved in 2000 by the Food and Drug Administration (FDA) in the United States for adult women with IBS-D, it was removed from the market later that year because of concerns about its safety, particularly severe constipation and ischemic colitis. However, as a result of public demand, the FDA in June 2002 reinstated alosetron for women with chronic, severe IBS-D unresponsive to conventional therapy. This required adherence to the manufacturer’s prescribing program starting at a lower dose of 0.5 mg twice daily. This lower dose has been shown to be effective in achieving global improvement in bowel symptoms for women with severe IBS-D and produces less constipation, although the risk of ischemic colitis is similar (approximately 1 in 750-1000 patients).