Zelnorm, a drug that is used to treat constipation associated with irritable bowel syndrome (IBS), has been taken off the market because of an increased risk of heart attack, stroke and death, US health officials said recently.
People who suffer from IBS have bowels that do not function properly and may experience symptoms such as abdominal pain or discomfort (often reported as cramping, bloating, gas, diarrhea, and/or constipation.
"Novartis, the maker of Zelnorm, has voluntarily agreed to stop marketing the drug in the United States," said Dr. John K. Jenkins, director of the Office of New Drugs, Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA).
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.
What The Review Found
It was discovered 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.
"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 reintroduction of Zelnorm, provided there is data that indicate that, for some patients, the benefits of the drug outweigh the risks, Jenkins said.
Patients Don’t Have Many Options
Dr. Roshini Rajapaksa, a gastroenterologist at New York University Medical Center and assistant professor at the NYU School of Medicine, said, "This is very big and disturbing news, because Zelnorm was really the only effective and approved drug available for irritable bowel syndrome 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."