On March 30, 2007 the FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.
Zelnorm (tegaserod) is a prescription drug for the short-term treatment of women with irritable bowel syndrome (IBS). Zelnorm is intended primarily to treat the constipation that accompanies IBS. (It has never been tested in men.)
The FDA based its decision to approve Zelnorm on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks. In these clinical trials, the most common possible side effects of Zelnorm were: abdominal pain; headache; diarrhea; nausea; gas; back pain; indigestion; upper respiratory tract infection; flu-like symptoms; sinusitis; urinary tract infection. A slight increase in abdominal surgeries (particularly gall-bladder removal) among Zelnorm users was noted during one of the trials.
The FDA was expected to approve Zelnorm one whole year before it actually did. This anticipated approval was abruptly halted as a result of concerns about an increase in gallbladder and other abdominal operations among patients testing the drug. European regulators raised similar concerns. Post-approval, the FDA has ordered Novartis to study how patients fare as sales begin, and pledged to closely monitor any reports of side effects.
In March 2006, a panel of European experts rejected Zelnorm for the European market for the second time, after re-examining the evidence following the initial December 2005 rejection of the drug.
The CHMP was concerned that the results of the study would not translate into real benefit to the patient treated to relieve the symptoms of this disorder in standard health care setting. The CHMP was of the opinion that Zelnorm’s benefits are not greater than its risks. Hence, the CHMP recommended that Zelnorm be refused marketing authorisation.
The London-based European Medicines Agency said the committee had reiterated the decision from December not to recommend Zelnorm for the relief of irritable bowel syndrome in women with constipation.
