Vytorin and Zetia Studies Ongoing
IMAGE SOURCE: ©iStockphoto/ cholesterol lowering drugs/ author: dlerick
It is unlikely that cholesterol drug, Vytorin, and related drug, Zetia, raise the risk of cancer.
That is the good news from the Food and Drug Administation (FDA) for Merck & Co. about its two cholesterol drugs. The FDA adds that a link cannot be ruled out.
Based on its review of data on the drug trial called SEAS, plus interim findings from two large ongoing studies, SHARP and IMPROVE-IT, FDA regulators say they “did not show an increased risk of cancer with Vytorin."
Vytorin and Zetia remain a $4 billion a year franchise for Merck, reports Reuters, although sales dropped 13.8% from one year ago.
A Merck spokesman says the FDA will continue to evaluate the medications and consumers should not stop using them in the meantime.
SHARP is expected to be concluded in 2010 and the other in 2012, at which time the FDA will make a final determination on cancer risk.
The Cancer Link
In September 2008, the editors of the New England Journal of Medicine (NEJM), which had published results from one study and partial results of two others, advised to use Vytorin with caution.
The review did not show a benefit, and scientists have observed there might be a link between Vytorin and cancer. In July, researchers reported that patients taking Vytorin had a 40 percent chance of dying from cancer when compared to those taking a placebo.
Vytorin is a combination drugs made up of Merck’s Zocor, a statin drug, and Schering-Plouugh’s Zetia, a newer cholesterol lowering drug.
The drug was approved by the Food and Drug Administration in 2002 on the basis of drug trials involving 3,900 patients for 12 weeks, not long enough to determine if the drug reduced heart attacks or cardiovascular disease. #