MEDLaw Legal Team Attorneys / Physician - Lawyers representing those injured by Zelnorm. Prescription lawsuit litigation.

Reports State that Irritable Bowel Syndrome (IBS) Medication Zelnorm May Increase Risk of Heart Attack and Stroke.

On March 30, 2007 the U.S. Food and Drug Administration (FDA) announced that Novartis Pharmaceuticals had agreed to the FDA's request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate).

According to the FDA, Zelnorm has been associated with an €śincreased risk of serious cardiovascular adverse events (heart problems).€ť In addition to heart problems, risks included ovarian cysts and fainting spells.

"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

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.

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.

Zelnorm was approved on July 24, 2002, as a medicine used for the short-term treatment of women who have irritable bowel syndrome with constipation (IBS-C) as their main bowel problem. On August 21, 2004, FDA approved Zelnorm or another use, the indication of chronic idiopathic constipation.

Our in-house legal team consists of a physician-attorney, five registered nurses, 11 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 medications, including Zelnorm.*

We have the experience to protect your legal rights and to help you obtain the compensation you deserve.  If you or a loved one have suffered serious side effects from the use of Zelnorm, please contact us for an immediate case evaluation.

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