A recent study on cholesterol-lowering drug Vytorin, called
SEAS, linking it to an increased risk of cancer made the US Food and Drug
Administration announce a thorough analysis on the drug, a notice posted on the
FDA’s Web site reads.
However, the agency said patients should not stop taking
Vytorin because there is not sufficient data to declare it dangerous. Two large
ongoing trials involving Vytorin showed no increased risk of cancer.
American Cancer Society epidemiologist Eric Jacobs sustained the same idea. “Nobody
should avoid taking a statin because of concerns about cancer,” he said.
Vytorin is made by a joint venture of Merck & Co.’ Zocor
and Schering-Plough Corp. The drug reduces the amount of cholesterol produced
by the liver. Mary-Fran Faraji, a spokeswoman from Schering-Plough, said the
SEAS study had more cancer cases because it included a longer period of patient
follow-up. She also added that the FDA investigation was expected.
The SEAS study was originally meant to determine whether
Vytorin could help prevent a worsening of heart valve disease, but it did not.
What is ironic is the fact that statins were being studied a few years ago as
a possible prevention for certain cancers, but those studies found no effect on
cancer, good or bad.
The FDA estimates that it will take the agency three months to receive final
results from the SEAS study and another six months to complete its review and
draw any conclusions.
Detailed results of the SEAS study will be presented at a cardiology
conference in Munich
on Sept. 2.
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