Zelnorm why recall

Patients taking Zelnorm should discontinue treatment and contact their doctors to discuss other treatment options. Novartis has also suspended the marketing and sales activities of Zelnorm in the United States at the request of the Food and Drug Administration.

As with any drug product, in order to avoid contaminating ground or municipal water systems, the product should not be flushed down the toilet or sink. Novartis has sent a letter to Canadian health care professionals informing them of this new safety information. Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.

Any case of serious cardiovascular ischemic events or other serious or unexpected adverse reactions in patients receiving Zelnorm should be reported to Novartis or Health Canada at the following addresses:. Novartis Pharmaceuticals Canada Inc. On March 30, , the FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation.

FDA analysis of safety data pooled from 29 clinical trials involving over 18, patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. The FDA issued this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm tegaserod maleate , Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm.

Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

The information on this page is provided for information purposes only. Zelnorm, a medication for treatment of irritable bowel syndrome IBS , has been removed from the market due to serious and potentially life threatening problems. Zelnorm side effects increase the risk of heart attacks, strokes and other potentially fatal injuries. Zelnorm generic name tegaserod maleate is manufactured by Novartis Pharmaceutical Corporation.