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March 31, 2007: Novartis to Discontinue Sales of Zelnorm, an IBS drug, After FDA Request

Due to the increased risk of heart attack and stroke associated with Zelnorm, the FDA has requested that the drug be taken off the market. The drug’s maker, Novartis Pharmaceuticals Corporation of East Hanover, NJ, has complied with that request with regard to sales in the U.S. Zelnorm is sold in 55 countries.

Zelnorm, a prescription drug on the market since July 2002, is used to treat women experiencing irritable bowel syndrome with constipation. The drug was approved in August 2004 to treat chronic constipation in men and women under age 65.

The FDA’s March 30 request regarding Zelnorm came in response to new information from 29 short-term, randomized, controlled clinical trials. The information was provided to the FDA by Novartis. According to an FDA press release, “FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.”

The data were taken from 11,600 patients receiving Zelnorm and over 7000 receiving a placebo. According to the FDA press release, 13 Zelnorm patients (0.1%) had cardiovascular ischemic events, while only one placebo-treated patient (0.01%) had an event. Cardiovascular ischemic events include angina, heart attach and stroke.

The FDA recommends that patients taking Zelnorm get in touch with their healthcare practitioners to discuss alternative treatments. Any patient experiencing severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of heart attack or stroke should seek emergency care.

If you or a loved one has been harmed by Zelnorm, you may request a free case evaluation from our firm. We also can be reached toll-free at 1-877–934-6271. For more information about how the Law Offices of Eric H. Weinberg have helped clients who have been harmed by pharmaceutical drugs, please visit Our Firm and Our Successful Cases on this website.

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