Zelnorm (tegaserod maleate) Sales Discontinued at Request of FDA

Have you taken Zelnorm? A new safety analysis indicates patients have an:

  • Increased risk of Heart Attack
  • Increased risk of Stroke
  • Increased risk of chest pains which could become a heart attack

 

The FDA reports that "Novartis Pharmaceuticals has agreed to FDA’s request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate). FDA’s request was based on newly available information of an increased risk of serious cardiovascular adverse events, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with use of the drug. Based on this new information, FDA has concluded that the overall risk versus benefit profile for the drug is unfavorable for continued marketing."

 

The FDA also reports that "Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation."

 

Note that the FDA states:

  • Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
  • Patients who are 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.


If you have taken Zelnorm and have had a heart attack, stroke or heart chest pain, learn more about your options and get an instant answer to your questions. Call today and speak with an Attorney: 1.800.838.0800.

Burke & Eisner Law Blog

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