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Novartis' Zelnorm recalled in US

Novartis suspends sales of IBS drug Zelnorm in US.


24 April,2007:

A commonly used drug to treat irritable bowel syndrome has been recalled in US following reports on serious heart problems. The drug in question, Zelnorm produced by the Swiss drug giant Novartis, is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation.

Subsequently Zelnorm got approved in for treatment of chronic constipation for men and women under age 65 in August 2004.Currently Zelnorm is marketed in 55 countries across the world.

The drug which contains tegaserod as active agent has been implicated to an increased risk of serious cardiovascular adverse events associated with its use by a study. The federal drug watchdog the Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. Novartis has agreed to voluntarily suspend marketing of the drug in theUnited States.

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.

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.

An estimated 12 million Americans suffer from the painful and disruptive symptoms of IBS with constipation. Many have symptoms for five to 10 years, which trigger missed work-days and often prevent them from participating in everyday activities with their family and friends.

Novartis markets the therapy under the trademark Zelnorm (tegaserod maleate) in the US, Canada, Philippines and South Africa; and as Zelmac (tegaserod) in Switzerland, Latin America and the Asia-Pacific region.





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