Wednesday, December 23, 2009

Merck's Vytorin ups cancer risk

Cholesterol drug Vytorin is unlikely to raise the risk of cancer but a link cannot be ruled out, U.S. health officials said on Tuesday.

The Food and Drug Administration reviewed data on Vytorin and Merck's related drug, Zetia, from a trial called SEAS, plus early findings from two large ongoing studies.

"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.

Vytorin and Zetia were tarnished in January 2008 when a study called ENHANCE raised questions about the drugs' effectiveness. Sales of the medicines plunged after the ENHANCE data, although they remain a $4 billion-a-year franchise.

Concern about cancer arose in July 2008 when the SEAS trial found more cancer cases among Vytorin patients versus a placebo.

Leerink Swann analyst Seamus Fernandez said the FDA statement on Tuesday was positive though expected.

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