FDA gives Merck a Christmas present: Rules increased cancer risk unlikely for Vytorin

WASHINGTON After taking a hammering in 2008, it appears that Merck’s blockbuster cholesterol drug Vytorin finally received some vindication as the calendar wound down on 2009. The Food and Drug Administration announced last week that it “believes it is unlikely that Vytorin or Zetia — the drug used in combination with Zocor to make Vytorin — increase the risk of cancer or cancer-related death.”

While FDA officials stopped short of ruling out any cancer risk altogether, the news was a positive for a drug that had shown so much promise out of the gate before a series of relatively small patient trials in 2008 cast a pall on Vytorin, which had been marketed to treat the two sources of high cholesterol: food and family.

First, in January 2008, the ENHANCE study questioned whether Vytorin’s effect was any better than placebo. Then, in July 2008, results from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) trial showed a heightened rate of cancer in patients taking Vytorin — 11.1% versus 7.5% of those patients on placebo.