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.
Increases in
blood sugar levels (hyperglycemia) have been reported
with statin use. The FDA is also aware of studies
showing that patients being treated with statins may
have a small increased risk of increased blood sugar
levels and of being diagnosed with type 2 diabetes
mellitus. The labels will now warn healthcare
professionals and patients of this potential risk.
Health care
professionals should take note of the new
recommendations in the lovastatin label. Some medicines
may interact with lovastatin, increasing the risk for
muscle injury (myopathy/rhabdomyolysis). For example,
certain medicines should never be taken (are
contraindicated) with Mevacor (lovastatin) including
drugs used to treat HIV (protease inhibitors) and drugs
used to treat certain bacterial and fungal infections.
Reporting side
effects to the FDA is important. Health care
professionals and patients should report any side
effects associated with statin use to FDA MedWatch
program.
For more
information:
FDA Drug
Safety Communication: Important safety changes
for the class of cholesterol-lowering statin drugs
http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
FDA
Expands Advice on Statin Risks
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm
FDA
Voice Blog
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM284955
Spanish
Version of News Release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294477.htm
The FDA, an agency within the
U.S. Department of Health and Human Services, protects
the public health by assuring the safety, effectiveness,
and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical
devices. The agency also is responsible for the safety
and security of our nation’s food supply, cosmetics,
dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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