Zelnorm Recall, Information and Warnings
Novartis Pharmaceutical’s constipation drug, Zelnorm (tegaserod maleate), has been recalled from the market at the request of the Food and Drug Administration (FDA). The FDA made this request after Novartis provided it with a new analysis of 29 studies, showing a significant risk of heart attack, stroke, and angina (chest pain) in patients taking Zelnorm.
Zelnorm Studies Show Increased Risk of Serious Side Effects
A pooled analysis was done of 29 short-term (1–3 months) randomized and controlled clinical studies that included more than 18,000 people. The analysis showed that the people in the studies using Zelnorm had a statistically greater risk of suffering a heart attack, a stroke, or angina than the study participants who took placebos.
The number of people suffering heart attacks, strokes, and angina in the studies was small, but the numbers were statistically significant when compared to the control group. Since irritable bowel syndrome (IBS) and constipation, the conditions Zelnorm is approved to treat, are not life-threatening conditions, they should not be treated with a drug that causes potentially life-threatening side effects. For this reason, the FDA concluded that the benefits of Zelnorm don’t outweigh the risk and the drug should be removed from the market.
Suffered harm from Zelnorm? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Zelnorm and Earlier Evidence of Less Serious Side Effects
Earlier evidence had already shown potential Zelnorm risks. Zelnorm was relabeled in 2004 when the FDA’s post-marketing adverse events reporting system showed 21 patients who reported serious consequences from diarrhea and 23 who were diagnosed with some form of reduced blood flow to the intestines. Serious consequences from diarrhea can include dehydration that may require hospitalization, low blood pressure, and fainting. Reduced blood flow to the intestines can cause serious intestinal damage and even death.
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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