The U.S. Food and Drug Administration said it’s “unlikely” Merck & Co.’s cholesterol drugs Vytorin and Zetia increase the risk of cancer or cancer-related death.
Still, the FDA said it can’t “definitively” rule out that the drugs may be associated with increased cancer risk.
“Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out,” the agency said in a posting on its Web site.
The FDA’s views come after it finished a review of a clinical trial that shocked the medical community when it showed an increased risk of cancer and deaths from cancer in patients taking Vytorin compared with those given a placebo.
Vytorin is a single-tablet combination of the drugs simvastatin and Zetia, which work by different mechanisms to lower bad cholesterol. Simvastatin is sold by Merck under the brand Zocor, but has been available from several generic manufacturers after losing U.S. patent protection in 2006.
The FDA has been reviewing Vytorin since the results of a study known as Enhance showed that Vytorin was no better than less-expensive simvastatin, at slowing artery-clogging despite reducing bad cholesterol to a greater degree.
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