Important safety changes to the labeling for some
widely used cholesterol-lowering drugs known as
statins are being announced today by the U.S. Food
and Drug Administration.
These products, when used with diet and exercise,
help to lower a person’s “bad” cholesterol
(low-density lipoprotein cholesterol). The products
include: Lipitor (atorvastatin), Lescol
(fluvastatin), Mevacor (lovastatin), Altoprev
(lovastatin extended-release), Livalo
(pitavastatin), Pravachol (pravastatin), Crestor
(rosuvastatin), and Zocor (simvastatin). Combination
products include: Advicor (lovastatin/niacin
extended-release), Simcor (simvastatin/niacin
extended-release), and Vytorin
(simvastatin/ezetimibe).
“We want health care professionals and patients
to have the most current information on the risks of
statins, but also to assure them that these
medications continue to provide an important health
benefit of lowering cholesterol,” said Mary Parks,
M.D., director for the Division of Metabolism and
Endocrinology Products in the Office of Drug
Evaluation II in FDA’s Center for Drug Evaluation
and Research.
The changes to the statin labels are:
The drug labels have been revised to remove the
need for routine periodic monitoring of liver
enzymes in patients taking statins. FDA now
recommends that liver enzyme tests should be
performed before starting statin therapy, and as
clinically indicated thereafter. FDA has concluded
that serious liver injury with statins is rare and
unpredictable in individual patients, and that
routine periodic monitoring of liver enzymes does
not appear to be effective in detecting or
preventing this rare side effect. Patients should
notify their health care professional immediately if
they have the following symptoms of liver problems:
unusual fatigue or weakness; loss of appetite; upper
belly pain; dark-colored urine; yellowing of the
skin or the whites of the eyes.
Certain cognitive (brain-related) effects have
been reported with statin use. Statin labels will
now include information about some patients
experiencing memory loss and confusion. These
reports generally have not been serious and the
patients’ symptoms were reversed by stopping the
statin. However, patients should still alert their
health care professional if these symptoms occur.
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