URGENT DRUG RECALL: ZELNORM
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At Health Canada's request, Novartis Pharmaceuticals Canada Inc. is suspending the marketing and sales of Zelnorm (tegaserod hydrogen maleate) tablets in Canada to permit further evaluation of Zelnorm important safety information.
At Health Canada's request, Novartis Pharmaceuticals Canada Inc. is suspending the marketing and sales of Zelnorm (tegaserod hydrogen maleate) tablets in Canada to permit further evaluation of Zelnorm important safety information.
Reason for recall is, a recent retrospective analysis of pooled clinical trial data showed that the incidence of cardiovascular ischemic events such as myocardial infarction, stroke, and unstable angina pectoris in patients taking Zelnorm was higher than in those taking placebo.
Consistent to this decision, Novartis is asking us (Canadian Pharmacists) and distributors to return the product to company and patients taking Zelnorm should discontinue treatment and contact their physician for advice about alternative therapies.
It seems Novartis has also suspended the marketing and sales of Zelnorm in the United States at the request of the Food and Drug Administration.
