The Food and Drug Administration will allow limited use of the irritable bowel syndrome drug tegaserod.
The agent, marketed by Novartis Pharmaceuticals as Zelnorm, will now be available under a treatment investigational new drug (IND) protocol to treat IBS with constipation and chronic idiopathic constipation in women under age 55 who meet specific guidelines, according to the FDA.
“These patients must meet strict criteria and have no known or preexisting heart problems and be in critical need of this drug,” Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a written statement. “Zelnorm will remain off the market for general use,” he added.
The drug was pulled off the U.S. market in late March in response to an FDA request. At the time, the FDA said that patients taking Zelnorm had a higher risk of adverse cardiovascular events. The relative risk of serious and life-threatening events was 0.1% for Zelnorm and 0.01% for those taking placebo. However, the agency also said it would work with Novartis to find a way to make the drug available to patients who had no other alternatives.
Zelnorm was approved in the United States in 2002 for short-term treatment of women with irritable bowel syndrome with constipation. A supplemental approval was granted in 2004 for chronic constipation in men and women under age 65.
Physicians who think their patients meet the IND criteria should call Novartis at 888-669-6682. Patients or physicians can also contact the FDA's Division of Drug Information at 888-463-6332 for other options.