Harvard Women's Health Watch

Managing irritable bowel syndrome without special drugs

Another IBS drug has been taken off the market because of serious side effects. Now what?

In March 2007, at the request of the FDA, the pharmaceutical company Novartis agreed to halt the sale of Zelnorm (tegaserod maleate), a drug used in the short-term treatment of irritable bowel syndrome (IBS) when the main symptom is constipation. Zelnorm was approved in 2002 for women with IBS and, later, for men and women under age 65 with chronic constipation. The FDA's request was based on an analysis showing that, compared with a placebo, Zelnorm slightly increased the risk for heart attack, angina, and stroke. But this wasn't the first sign of trouble for the drug. Its label had already been changed, in 2004, to include warnings about serious side effects, including ischemic colitis (lack of blood flow to the intestine).

Zelnorm is the second IBS drug to be recalled. Lotronex (alosetron hydrochloride), approved in early 2000 for women with diarrhea-predominant IBS, was pulled from the market within nine months, after studies linked it to ischemic colitis and bowel obstruction. Propulsid (cisapride), a heartburn drug often used by IBS sufferers, was also withdrawn that year because of cardiovascular risks.

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