-On March 30, Novartis announced that it is complying with an FDA request to suspend marketing of Zelnorm.
-Patients who are taking Zelnorm should call our office at (305) 913-0666 to schedule an
appointment
in order to discuss other treatment options with their doctor.
-According to Novartis, patients can return any unused and unexpired Zelnorm tablets to Novartis for reimbursement of out-of-pocket costs. More information can be obtained by calling the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682). For more information from Novartis, please visit www.novartis.com
-FDA announces the following, effective immediately - for more information from the FDA, please visit: http://www.fda.gov/cder/drug/infopage/zelnorm/default.htm
The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States. Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was then approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.
FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. "This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."
Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks. The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.
FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks. Any such proposal would be the subject of a public advisory committee meeting before an FDA decision.