Mar. 23 -- FRIDAY, March 30 (HealthDay News) -- Zelnorm, a drug to treat constipation associated with irritable bowel syndrome, has been taken off the market because of an increased risk of heart attack, stroke and death, U.S. health officials said Friday.
"Novartis, the maker of Zelnorm, has voluntarily agreed to stop marketing the drug in the U.S.," Dr. John K. Jenkins, director of the Office of New Drugs, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said during a teleconference.
Zelnorm (generic name tegaserod maleate) was first approved by the FDA in 2002 for the short-term treatment of women with irritable bowel syndrome whose primary symptom was constipation. Two years later, the drug was approved for the treatment of chronic constipation in men and women under age 65, Jenkins said.
The withdrawal was prompted by a recent review of 29 studies. The review was undertaken by Novartis at the request of a Swiss health agency. The FDA reviewed that data and decided that the risk-to-benefit profile of Zelnorm was no longer favorable, Jenkins said.
The review found that 13 out of 11,614 patients taking the drug had a cardiac event, including one death, compared with one case among 7,031 patients who took a placebo, he said.
"While the absolute risk was small, the relative risk was significantly greater," Jenkins said.
The FDA is advising patients who take the drug to see their doctor to discuss alternative treatments, Jenkins said. "There may be some patients with severe symptoms that do not have other effective treatment options," he said.
The agency has agreed that Novartis can make a new drug application to allow patients with no other treatment options to get Zelnorm, Jenkins said. "For these patients, the benefits may outweigh the risks," he said.
The FDA has also agreed to consider a re-introduction of Zelnorm, provided there is data that indicate that, for some patients, the benefits of the drug outweigh the risks, Jenkins said.
The withdrawal of Zelnorm follows Thursday's withdrawal of the Parkinson's drug Permax, which was taken off the market, because it was linked to an increased risk of heart valve problems.
Dr. Roshini Rajapaksa, a gastroenterologist at New York University Medical Center, said, "This is very big and disturbing news, because Zelnorm was really the only effective and approved drug available for irritable bowel syndrome (IBS) with constipation.
"IBS is the most commonly diagnosed gastrointestinal condition and is second only to the common cold as a cause of absence from work," he added. "People, mostly women, really suffer from this condition, and Zelnorm offered real relief to many. I think patients are going to be very reluctant to give up the Zelnorm, but strokes and heart attacks are much more deadly than IBS, so it is appropriate to pull the drug."
For more information on IBS, visit the U.S. National Digestive Disease Clearinghouse.
SOURCES: Roshini Rajapaksa, M.D., a gastroenterologist at New York University Medical Center and assistant professor at the NYU School of Medicine, New York City; March 30, 2007, teleconference, John K. Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration