Vytorin Cancer Link Not Seen by FDA

Federal regulators indicate that it is unlikely that the cholesterol drug Vytorin causes cancer, despite a clinical study in 2008 which raised potential Vytorin cancer concerns.

The FDA announced the findings of its review of the cholesterol drugs on Tuesday, saying that while no evidence was found linking Vytorin to cancer, investigators were also unable to totally rule out a connection.

A review of Vytorin was initiated after preliminary results from a clinical trial, known as SEAS (Simvastin and Ezetimibe in Aortic Stenosis), found higher incidents of cancer among patients treated with Vytorin than in those given a placebo.

According to a follow up statement released December 22, the FDA reviewed the SEAS trial findings and found no pattern that would indicate a cancer link. The types of cancer that were diagnosed in participants of the SEAS trial varied greatly, which FDA reviewers said is unlikely if there was one cancer-causing agent in common with all the cases. In addition, there was no link between duration of Vytorin use and increasing incidents of cancer, and other Vytorin studies failed to see similar cancer connections.

Vytorin is a cholesterol drug that combines Zetia (ezetiminbe) with Zocor (simvastin). It was approved by the FDA in 2004 and was heavily marketed as part of a joint venture between Merck and Schering-Plough.

The drug has come under fire over the past year after other studies suggested that the drug may be less effective in fighting high cholesterol than older, cheaper drugs.

In August, Merck & Co. and Shering-Plough Corp., which jointly market the drug, agreed to pay $41.5 million to settle Zetia and Vytroin class action lawsuits filed for consumers who alleged that the companies hid data for two years that showed the drug to be less effective than advertised. The companies also paid $5.4 million in July to resolve investigations by numerous states into whether they acted illegally in the handling of an effectiveness study, a clinical trial known as ENHANCE.

Questions were raised about the companies’ actions months before the data was released, when the drug makers indicated that they were going to change the ENHANCE study’s measure of effectiveness a year and a half after the study had been concluded. These actions also led to a congressional investigation into whether the drug makers were trying to manipulate scientific data.