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New Bowel Drug OKd

July 29, 2002|From Associated Press

WASHINGTON — Women who suffer constipation-causing irritable bowel syndrome won their first government-approved treatment on Wednesday. But while its maker predicts Zelnorm will prove a big hit, a critic already is charging that health authorities shouldn't have let it sell.

Zelnorm's approval comes just weeks after the Food and Drug Administration let another controversial bowel drug, Lotronex, back on the market, two years after serious side effects halted its sales.

The two drugs are for different types of irritable bowel syndrome, a mysterious disorder that gives millions of Americans, mostly women, abdominal pain and either severe diarrhea or constipation or both. Lotronex is for the diarrhea type, while Zelnorm on Wednesday became the only FDA-approved therapy for women with constipation-predominant IBS.

Laxatives don't relieve the cause of IBS. Zelnorm appears to go a step further, acting on nerve cells to speed the colon's movement of stools.

Public Citizen, a consumer advocacy group, attacked the FDA's decision, saying it was ignoring early signals of Zelnorm risks just as the agency two years ago downplayed complaints that eventually derailed Lotronex.

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