Home : Unsafe Drugs : Zelnorm

Zelnorm Side Effects

Name: Zelnorm
Generic: Tegaserod maleate
Manufacturer: Novartis
Date approved: 2002
Status: Voluntarily withdrawn from market in United States upon request of the federal Food and Drug Administration (FDA)
Approved uses: Short-term treatment of chronic constipation in women with irritable bowel syndrome (IBS); treatment of chronic constipation in patients age 65 and under.
Off-Label uses: Treatment of IBS in men; treatment of idiopathic constipation in patients over 65 years of age
Side effects:
  • Zelnorm has been linked with a higher chance of stroke
  • heart attack
  • and chest pain in some patients. Other Zelnorm side effects include abdominal pain
  • diarrhea and headache.
Related topics: Strattera, Tequin
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Zelnorm

Zelnorm (tegaserod maleate) is a drug used in the treatment of irritable bowel syndrome (IBS) and manufactured by Novartis.  It was approved for short-term treatment of constipation in IBS-affected women and for chronic constipation in patients 65 years and younger.  In 2007, Zelnorm was found to cause an increased risk of stroke and heart attacks in patients and Novartis, at the urging of the federal Food and Drug Administration (FDA), withdrew Zelnorm from the market in the United States. 

Novartis Recalls IBS Drug Zelnorm

But Zelnorm, the IBS drug produced by Novartis, has been linked to serious side effects, including stroke and heart attack, and now it's been pulled from store shelves in a voluntary recall. The Zelnorm recall took place upon the urging of the federal Food and Drug Administration (FDA), who analyzed data from nearly 30 clinical trials that showed over 18,000 patients who suffered from adverse cardiovascular events, including stroke, heart attack, and angina. This news has shaken Novartis, who previously predicted that Zelnorm would rake in over $1 billion by 2011 and launched a high-visibility ad campaign featuring writing on slender, toned stomachs to tout the new drug. read more

Zelnorm Side Effects: Know the Risks

With recent news that Zelnorm, Novartis' "breakthrough" drug for the treatment of IBS (irritable bowel syndrome), has been taken off of store shelves due to safety concerns, you might be wondering just what risks you take when you take a Zelnorm tablet. Though manufacturer Novartis has denied the FDA's substantial claims against Zelnorm (the result of an exhaustive analysis of nearly 30 Zelnorm studies), the risks are clear: Zelnorm has been linked to cardiovascular symptoms in roughly one percent of patients, as opposed to 0.01 percent in patients taking a placebo. Zelnorm has since been approved for use in IBS patients under age 65 and has been prescribed off-label to male patients suffering from IBS-related constipation and those patients who suffer from constipation of unknown origin. read more

View the Zelnorm Law Articles page here

Zelnorm FDA Information

Zelnorm (tegaserod maleate) Information

U.S. FDA CDER Home Page

View the Zelnorm FDA Information page here

Zelnorm News Articles

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Zelnorm Useful Web Sites

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Zelnorm Wikipedia

Tegaserod

Irritable bowel syndrome

View the Zelnorm Wikipedia page here

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