In March 2007, the U.S. Food and Drug Administration issued a health advisory to inform the public that Zelnorm was being taken off the market because it has been found to increase the risk of heart attack, stroke, and worsening heart chest pain. The benefits no longer outweighed its risks.

Zelnorm is a prescription drug manufactured by Novartis Pharmaceuticals that is approved for short-term treatment of women with irritable bowel syndrome (IBS) with constipation. It's also given to people under 65 with chronic constipation.

DID YOU KNOW?

At the time it was pulled from the market, more than half a million people were taking Zelnorm.

Studies have linked Zelnorm (tegaserod maleate) to an increased risk of adverse cardiovascular events including heart attacks, strokes, angina and other side effects. Safety data from 29 clinical trials involving over 18,000 patients showed that cardiovascular ischemic events occurred in 13 out of 11,614 patients treated with Zelnorm (0.11%), compared with one case in 7,031(0.01%) patients treated with a sugar pill they thought was Zelnorm. All patients affected had pre-existing cardiovascular disease and/or cardiovascular risk factors.

Based on those results, the FDA advised patients taking Zelnorm to contact their physician to discuss alternative treatments for their condition, and recommended that physicians work with their patients to transition them to other therapies as appropriate to their symptoms and need.

In addition, the FDA stated that patients who were taking Zelnorm should seek emergency medical care right away 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.

In 2001, at the urging of the consumer group Public Citizen, the FDA refused to approve Zelnorm. Public Citizen said the drug increased the risk of ovarian cysts. The FDA requested more information regarding the effects of Zelnorm on patients undergoing gall-bladder surgery.

The FDA approved Zelnorm in 2002 for the short-term treatment of irritable bowel syndrome in women. Two years later, it requested that warnings about diarrhea and ischemic colitis be added to the label. According to the FDA, several Zelnorm deaths were reported among patients with these conditions.

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If you or a loved one has take Zelnorm and suffered from a heart attack or stroke, contact us today. The MEDLAW legal team at Janet, Jenner & Suggs, LLC, consists of a physician, five registered nurses, 13 attorneys, and more than 30 staff members. As one of the nation's premier pharmaceutical liability law firms, we represent consumers nationwide who have been victimized by defective pharmaceutical drugs and over-the-counter products, including Zelnorm.

In addition to our medical experience, we have received the highest rating for ethical conduct and professional excellence offered by Martindale-Hubbell® ("AV"). We are recognized in the Best Lawyers in America, and have been long-recognized as leaders in our profession.

Please feel free to contact us at 1-888-4-MEDLAW if you have questions or concerns.