Zelnorm Information
What is Zelnorm?
Zelnorm (tegaserod maleate) was approved by the FDA in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation and approved in August 2004 for men and women younger than 65 with chronic constipation. Zelnorm works by increasing the action of serotonin (a body chemical) in the intestines. This speeds the movement of stools (bowel movements) through the bowels. In March 2007, Novartis agreed to voluntarily suspend sales of Zelnorm following reports of adverse side effects such as heart attack and stroke and withdrew Zelnorm from the market.
- Zelnorm Now Available Only To Patients Who Require Hospitalization Because Their Condition Is Life-Threatening
- In April 2008 Novartis further restricted access to its drug Zelnorm, reserving it only for the sickest patients who have irritable bowel syndrome. Now, under this new approach, the FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use.
- After Zelnorm Withdrawn from Market, FDA Permitting Restricted Use
- The FDA announced in July 2007 that it will make the Novartis drug Zelnorm available to select patients suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) through a drug program formally known as an investigational new drug protocol (IND). The treatment IND is a way for the FDA to allow patients with a serious disease such as irritable bowel syndrome with constipation who are not enrolled in a clinical trial to be treated with a drug not approved by the FDA when no comparable or satisfactory alternative drug is available.
- IBS Drug Zelnorm Withdrawn From Market
- Zelnorm, a serotonin agonist generically known as tegaserod, was prescribed to patients with severe constipation from irritable bowel syndrome (IBS). In a recent analysis of clinical trials, Zelnorm was found to be associated with cardiovascular events such as heart attack and stroke, prompting the FDA to decide that the risk-versus-benefit profile for Zelnorm was no longer favorable.
- Zelnorm and Legal Compensation
- If you experienced serious side effects from the use of Zelnorm, or a person died due to an adverse reaction while taking Zelnorm, you may have a claim for legal compensation. Statutes of limitations can prevent obtaining legal compensation for Zelnorm side effects causing personal injury or death.
- Zelnorm Class Actions
- We believe that people who have suffered a serious injury or died from Zelnorm side effects are better served when an individual lawsuit is filed on their behalf.
- March 30, 2007 Dear Doctor Letter
- Dear Doctor Letter from Novartis to healthcare professionals announcing compliance with FDA request to withdraw Zelnorm from the market.
- Press Release from Novartis Regarding Zelnorm
- Novartis announcement of voluntary withdrawal of Zelnorm from the market. FDA asked Novartis to suspend sales of Zelnorm following analysis of trial data showing adverse side effects associated with Zelnorm such as heart attack and stroke.
- Zelnorm Information from FDA
- FDA announcement that Novartis Pharmaceuticals agreed to FDA’s request to voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate). The 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.
- FDA Press Release Regarding Zelnorm
- FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons. FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives.
- FDA Questions and Answers About Zelnorm
- Free Zelnorm Case Evaluation
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