ZELNORM RECALL LINKED TO CARDIOVASCULAR AND STROKE RISKS

3.30.07: Zelnorm is voluntarily taken off the market at the request of the FDA after recent findings identified an increased risk of serious heart problems or stroke associated with its use.

Background:

Zelnorm, also known as tegaserod maleate, is a prescription medicine approved for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Zelnorm has been prescribed to about 500,000 patients. Zelnorm is being taken off the market after a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm. The FDA has notified patients and healthcare professionals of these risks.

A recent analysis was conducted on the data collected before the drug was approved by the FDA in 2002. The study revealed a significant imbalance of cardiovascular risks in people taking Zelnorm compared to those taking the placebo. Data reveals that 0.11% of patients taking Zelnorm experienced cardiovascular risks such as heart attack, stroke, and reoccurring heart pain and discomfort, compared to 0.01% of patients treated with the placebo.

The FDA approved Zelnorm, made by Swiss pharmaceutical company Novartis International, in July 2002. The decision to approve Zelnorm was based on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks. In light of these recent reports linking Zelnorm to heart problem, the FDA is advising patients who are using the prescription drug 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.

The FDA has also received 21 reports of patients with diarrhea so severe that it caused complications such as low blood pressure and fainting. The FDA has also received 20 reports of ischemic colitis (reduced blood flow to the intestines), and 3 reports of patients with a similar intestinal problem. In some patients, these serious side effects have led to hospitalization, surgery and even death.

Additional Information:

What can you do?

Zimmerman Reed is investigating claims of patients who have had heart attacks or strokes that are believed to be associated with their use of Zelnorm. If you have experienced any serious side effects, you are urged to see your doctor. It may also be important to contact an attorney who can help you protect your potential legal claim. If you would like more information, or would just like to talk with a lawyer experienced in this litigation, please call attorney Stacy Hauer at 1.800.755.0098 for a free consultation or click here to fill out a confidential, free online case review. We welcome any questions you may have.