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Zelnorm Public Health Advisory Issued by FDA

May 8th, 2007

"Zelnorm Health Advisory"

The Food and Drug Administration (FDA) released a public health advisory on May 3, 2007, notifying healthcare professionals and patients that Zelnorm , a prescription drug used to treat irritable bowel syndrome and constipation, has been taken off the market and will no longer be sold.

Zelnorm (tegaserod maleate) was pulled from the United States market on March 30, 2007 after safety analyses, sponsored by Novartis Pharmaceuticals—the drug's maker—found that patients treated with Zelnorm have a significant risk of experiencing a heart attack, chest pain, or stroke.

FDA Recommendations

The FDA's public health advisory includes the following recommendations:

Patients who have been treated with Zelnorm should contact their doctors to discuss an alternative treatment regimen.
Patients who are currently taking Zelnorm should get medical care immediately if they experience shortness of breath, chest pain, dizziness, any symptoms suggesting a stroke or heart attack, or sudden difficulty walking or talking.
Physicians who have prescribed Zelnorm for any reason should switch to other treatments as appropriate to their patients' needs.

Clinical Studies of Zelnorm Risks

Novartis Pharmaceuticals provided the FDA with the results of 29 clinical studies of Zelnorm that were combined to assess the side effects and risks presented by Zelnorm treatment. The data from more than 11,000 patients given Zelnorm were studied and compared with data obtained from more than 7,000 control subjects given a placebo. It was found that the group given Zelnorm had a significantly higher chance of developing severe and life-threatening effects such as adverse cardiovascular events.

(Source: FDA website)

Have you been treated with Zelnorm? Contact us today to discuss your legal rights and options.

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