SUNDAY August 24, 2008 (foodconsumer.org) -- The Food and
Drug Administration on Aug 21 issued a statement saying it has informed
health care professionals that the agency was investigating a report that linked
use of Simvastatin and Ezetimibe with an increased risk of a variety of cancers
in Aortic Stenosis (SEAS) trial.
Simvastatin and Ezetimibe are two main ingredients for a cholesterol-lowering
drug called vytorin made by Merck and Schering-Plough Pharmaceuticals, meaning
that this drug might be associated with increased risk of cancer.
The FDA said on its website that the investigation has
not been completed and no action is being taken that would affect vytorin, nor
that the agency advised health care professionals to stop prescribing the drug.
The trial was intended to test whether lowering
LDL-cholesterol with vytorin would reduce the risk of cardiovascular
disease/events, which have been claimed to be the case for years, in people with
narrowing of the aorta, the body's largest artery.
The five-year trial showed disappointing results
suggesting that the drug did not reduce cardiovascular risk.
Rather a larger percentage of patients
receiving vytorin were diagnosed with and died from a variety of cancers
compared to those treated with a placebo, according to the FDA statement.
The full report on the trial results are expected in
three months and an official review and assessment would take another six
months.
At this time, the agency said
there is no need to stop patients from taking vytorin, but doctors are urged to
monitor patients closely.
The FDA also said although one study revealed the association.
Two other studies currently underway did not
show an increased risk associated with use of vytorin, the Associated Press
reported.
An early study showed the combo vytorin is no better than
simbastatin (Zocor) in terms of its ability to reduce the buildup of plague in
arteries.
Cholesterol-lowering drugs commonly known as statins are
very effective at lowering cholesterol. But the purpose of the drugs is to
reduce risk of cardiovascular disease and events.
Early studies have showed however that the benefits
of these drugs are limited, to a point that many believe use of statins may not
be justified.
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