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Monday, April 30, 2007

Irritable Bowel Syndrome Drug ZELNORM

On April 2, 2007 the FDA removed Zelnorm from the market after analyzing the results of an extensive study of the drug’s performance. The analysis included data from more than 18,000 patients. The conclusion was that the benefits of the drug do not outweigh the risks. Those risks include serious cardiovascular events such as severe angina, heart attacks and strokes. Zelnorm has also been linked to severe cases of diarrhea, ischemic colitis and some deaths.

Since being approved by the FDA in 2002, Zelnorm, manufactured by Swiss drug maker Novartis AG, was initially approved to treat irritable bowel syndrome coupled with constipation for women under age 65. Zelnorm had no effect on men and was not prescribed for them. The primary symptom is constipation. The drug increases the movement of stools through the bowels. It does not cure irritable bowel syndrome but it had been shown to help the condition. The drug has also been used to treat ischemic colitis and irritable bowel syndrome with diarrhea.

Prior to being recalled it was under prescription to about 500,000 people and in 2006 alone the drug generated just under five hundred million dollars in revenues for Novartis.

If you or someone you know has been taking Zelnorm, we suggest that you follow up with your health care provider to discuss alternative treatment options. If you have suffered any of the risks we’ve noted, you can call us to discuss your legal rights and we will guide you as to how to ensure that they are adequately protected. Time is of the essence in matters such as these so don’t delay. It is crucial that you act immediately so that medical evidence is preserved and your legal rights protected.

For more information, contact the Law Offices of Michael J. O'Connor & Associates at 800-518-4529 or visit our website to fill out one of the contact forms (http://www.oconnorlaw.com/). The initial consultation is free and the firm works on a contngency fee basis, so you pay nothing unless we recover money for you.

posted by Michael J. O'Connor & Associates at 10:14 AM

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