Harvard Women's Health Watch

In the news: FDA approves one drug for irritable bowel syndrome but suspends another

In the news

FDA approves one drug for irritable bowel syndrome but suspends another

Irritable bowel syndrome (IBS) is a chronic condition characterized by recurrent bouts of constipation or diarrhea (or both, alternating), abdominal pain, gas, and bloating. It's a functional disorder — that is, one that isn't attributable to any underlying disease or structural abnormality. Though there's no cure, there are many treatment methods that vary depending on the predominant symptoms. Several medications are available, but the prescription drugs approved for IBS have had a checkered history.

In April 2008, the FDA approved Amitiza (lubiprostone) for use in women ages 18 or over who have constipation-predominant IBS (IBS-C). Amitiza, which belongs to a class of drugs called prostones, is now the only widely available prescription medication for IBS-C. In March 2007, another IBS-C drug, Zelnorm (tegaserod), was taken off the market because of a slightly increased risk for heart attack, angina, and stroke. It came back in July 2007 under a special program that made it available to women under age 55 for whom nothing else worked. But in March 2008, the program was suspended by Zelnorm's manufacturer, Novartis Pharmaceuticals. Now, the drug can be used only in life-threatening situations or when hospitalization is necessary.

Another IBS drug, Lotronex (alosetron), has also had a rocky regulatory history. Approved in 2000 for women with diarrhea-predominant IBS (IBS-D), Lotronex was taken off the market nine months later because of reduced blood flow to the intestine (ischemic colitis) and severe constipation that resulted in 44 hospitalizations and five deaths. Two years later, it was back on the market, under a restricted prescribing program that's still in effect.

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