Swiss recall Zelnorm equivalent

By Austin Kirk
Posted June 4, 2007

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Following a Zelnorm recall in the United States on March 30 2007, Swiss pharmaceutical regulators announced last week that they have ordered the manufacturer, Novartis AG, to remove the foreign equivalent, Zelmac, from the market.  Swissmedic, the country’s regulatory agency, determined that the risk of heart attacks, strokes and angina outweighed the benefits provided by the irritable bowel syndrome drug.

>>INFORMATION: Zelnorm Recall

Questions regarding the safety of Zelnorm (generic tegaserod maleate) surfaced after analysis of clinical data involving 18,000 patients demonstrated that a statistically significant number of cardiovascular events occurred among individuals taking the drug.  The medication provides limited benefits in treatment of irritable bowel syndrome with constipation, yet Zelnorm side effects could cause a 7 to 8 fold increased risk of serious injury or death.

The Swiss are at least the fourth country to require Novartis stop selling the drug, following Zelnorm recalls in Australia, Canada and the United States.  In addition, the drug was rejected two times by the the EMEA (European Medicines Agency) in 2005 and again in 2006. 

At the time Zelnorm was recalled in the United States, it was taken by 500,000 people and had been prescribed over 2.6 million times in 2006.  Thousand of otherwise healthy people could have suffered heart attacks, strokes or other serious injury while trying to obtain relief from the non-life threatening irritable bowel syndrome, since the manufacturer failed to provide adequate warnings regarding the risks associated with Zelnorm.

ZELNORM LAWSUITS

Since early April 2007, the Zelnorm lawyers at Saiontz and Kirk, P.A. have been accepting new cases for users who suffered from ischemic colitis, heart attacks, strokes or death.  Zelnorm lawsuits are being reviewed nationwide, and there are no fees or expenses unless there is a recovery.  To determine if compensation may be available, request a free Zelnorm claim evaluation.