FDA Finds No Increased Cancer Risk with Vytorin

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The FDA has found no evidence for elevated cancer risk with Vytorin, a combination drug that helps to lower the risk of cardiovascular problems, the agency said in a written statement.

In an evidence review of three clinical trials, the FDA found that there was no increase in cancer incidence in patients taking the product, a combination simvastatin and ezetimibe that is manufactured by Merck & Co., Inc., in Whitehouse Station, N.J. This finding contrasts with a 2008 clinical trial that raised concern because cancer developed in substantially more patients taking Vytorin than placebo.

Upon completing reviews of three clinical trials, FDA stated that Vytorin lowered the risk of heart-related problems by 16%. Merck is seeking FDA approval for use of Vytorin in patients with chronic kidney disease, which would make it the first treatment of its kind for this indication.

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