FDA gives Vytorin clean bill of health but cannot rule out cancer risk

By Calvin Palmer

The Food and Drug Administration hedged its bets today with its ruling on the cholesterol drug Vytorin.

Federal regulators said a review of data from various studies show no evidence that the drug causes cancer. However, the agency added a caveat – it cannot definitely rule it out.

Vytorin is a big money earner for its manufacturer, Merck & Co. The drug combines two cholesterol pills, Zetia and Zocor, which is available as an inexpensive generic drug. Vytorin and Zetia together once generated $5 billion annually.

In January 2008, research indicated that Vytorin was no more effective at limiting plaque buildup in arteries than Zocor, which costs about one-third as much. Six months later,  preliminary results from SEAS study indicated a possible increased risk of cancer in patients getting Vytorin, compared to those getting dummy pills.

The FDA announced an extensive review of the data in August 2008, the FDA said it would do an extensive review of the data. Its results, reported today, are based on several studies of Zetia and Vytorin, including animal testing and patient studies from the SEAS trial as well as two large ongoing studies of the effects of both drugs on the cardiovascular system.

The FDA said that while there is lots of evidence Zocor is not linked to cancer, long-term patient data on Zetia, the other component of Vytorin, “is insufficient to definitively rule out a cancer risk at this time”.

“FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol-lowering medications,” the agency said in a statement.

It advised consumers with questions to consult their doctor.

“We’re pleased with the conclusions reached by the FDA,” said Merck spokesman Ron Rogers. “Merck strongly supports the efficacy and safety profiles of Vytorin and Zetia.”

Merck, based in Whitehouse Station, New Jersey, is the world’s second-biggest pharmaceuticals manufacturer.

[Based on reports by The New York Times and Associated Press.]

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