Withdrawn IBS drug to be available on limited basis
NEWS IN BRIEF — Posted Aug. 20, 2007
Some patients will now be allowed access to the drug Zelnorm (tegaserod maleate), according to statements issued by the Food and Drug Administration last month. Women younger than 55 who have irritable bowel syndrome with constipation or chronic idiopathic constipation, but lack other options and do not have known heart problems, will be permitted to take it. Patients must also sign consent materials to assure that they are informed of the risks and benefits of taking this drug.
This medication was pulled from the market in March because of evidence associating it with an increased risk of heart attack, stroke and worsening of chest pain.
"These patients must meet strict criteria and have no known or preexisting heart problems and be in critical need of this drug," said Steven Galson, MD, MPH, director of the agency's Center for Drug Evaluation and Research. "Zelnorm will remain off the market for general use."
Physicians who want to get this drug for their patients should contact the manufacturer, Novartis Pharmaceuticals, at 866-248-1348 or 888-669-6682.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/08/20/hlbf0820.htm.