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.
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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.
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