Vytorin, manufactured by Merck & Co. and Schering-Plough was introduced as the newest weapon in the fight against “bad” cholesterol. But last week the U.S. Food and Drug Administration dealt another blow that strengthens the argument that perhaps it’s the drug that’s bad, when it linked Vytorin use to an increased risk of cancer.
Vytorin, a combination of Merck’s Zocor (simvastatin), and Schering-Plough’s Zetia (ezetimibe), began taking hits in December 2007, when the FDA reported that the combination of Zetia and statin drugs, like Zocor, can increase the risk of liver damage and disease.
Then, in February 2008, the results of the drug manufacturers’ ENHANCE study, which were delayed for two years after the study’s April 2006 completion, pointed to the fact that Vytorin showed no significant benefit in slowing arterial plaque buildup. In fact, the study showed that patients taking Vytorin might actually have more plaque growth than patients taking only a simvastatin.
Now, in the worst news yet for the drug, the FDA issued a MedWatch alert Aug. 21 to inform healthcare professionals that the agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial of a possible link between Vytorin use and the increased risk of cancer and cancer death.
The FDA announced there are 3 months left until completion of the final SEAS study report, and that it would need an additional 6 months after receiving that data to evaluate the clinical data and other relevant information. In the meantime, they are advising patients to continue taking Vytorin and consult with their physician.
The announcement of the possible Vytorin-cancer link caused controversy, with some experts arguing that the results of the SEAS study are incomplete and may be a fluke. However, Dr. Jeffrey Drazen, editor of The New England Journal of Medicine, warned that the implications should not be “brushed aside,” according to a report by USA Today released this morning.
Dr. Drazen, along with four other editors, including two statisticians, published an editorial in the NEJM skeptical abut the safety of Vytorin and saying that it has raised uncertainty among physicians and patients.
According to the USA Today article, researchers found evidence that patients who took Vytorin appear to have at least a 40 percent greater risk of dying from cancer than those who took a placebo.
The results of the SEAS trial, which involved 2,000 patients, are being compared to two other ezetimibe studies, SHARP and IMPROVE-IT, which are still ongoing, and which involve more than 10,000 patients combined.
Some researchers say that a definite answer about the connection between ezetimibe and cancer will not be known until those studies are complete in 2012, USA Today reports. However, other experts warn that it is just as impossible to rule out a link between the drug and cancer, according to the news report.