Zelnorm Warning: Zelnorm Side Effects and Risks
Novartis Pharmaceuticals, the manufacturer of Zelnorm, voluntarily recalled the drug at the request of the Food and Drug Administration (FDA) in March 2007. Zelnorm (tegaserod maleate) was approved by the FDA for the short-term treatment of women with constipation as the main symptom of irritable bowel syndrome (IBS) on July 24, 2002. It was approved for the treatment of chronic idiopathic constipation on August 21, 2004.
Zelnorm Pulled from U.S. Market
In March 2007, the FDA asked Novartis to stop sales of Zelnorm in the U.S. effective immediately. The FDA’s action was the result of a new analysis of 29 clinical studies of Zelnorm that showed an increased risk of heart attack, stroke, and angina (chest pain) in patients who took Zelnorm.
Previous Zelnorm Label Warning
This was not the first FDA Zelnorm warning. In 2004, the FDA had Novartis change the professional labeling for Zelnorm to warn about possible Zelnorm side effects, including diarrhea and complications due to decreased blood flow to the intestines.
Zelnorm Recall
The Zelnorm recall means that the drug will be taken out of pharmacies and patients will be able to return unused Zelnorm and get reimbursed. The drug may still be available to patients with no other treatment options under a protocol the FDA will have to approve. Novartis can ask that Zelnorm be re-introduced to the market in a limited way if it can prove that there is a group of patients who may receive greater benefit than risk from Zelnorm. Such a re-introduction could only take place after a public advisory committee meeting.
Suffered harm from Zelnorm? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Zelnorm is still available in other countries under the name Zelmac. It is currently approved for use in Australia, Canada, Switzerland, and 52 other countries.
More Articles
Check out the following articles for more information about Zelnorm, filing a Zelnorm lawsuit and finding a Zelnorm attorney.
Suffered harm from Zelnorm? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
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