Studies Lead to Withdrawal of Drug for Bowel Ailment

By GARDINER HARRIS
WASHINGTON, March 30 — The maker of Zelnorm, a medicine that treats constipation-related irritable bowel syndrome, stopped selling the drug Friday after federal drug officials concluded that it might cause heart attacks and strokes.
In 29 studies, 13 of 11,614 patients given Zelnorm had heart problems, including one who died. Just one of 7,031 patients given placebos had similar problems.
Officials at the Food and Drug Administration said the drug was not effective enough to merit such risks.
Executives at the drug’s maker, Novartis, the giant Swiss drug concern, said the studies’ findings could be a fluke and vowed to continue selling Zelnorm in Europe.
Driven by aggressive advertising, Zelnorm had $561 million in sales last year, up 34 percent from 2005. About 500,000 people are currently taking the medicine for the ailment, which is also known as I.B.S.
Patients criticized the food and drug agency’s decision.
“I can’t believe the F.D.A. would do such a thing. Why are they being so cruel?” asked Lori Egan, 39, of Fredericksburg, Va. “I would rather take my chances of having a heart attack than live in I.B.S. hell.”