Press Announcements > FDA announces safety changes in labeling for some cholesterol-lowering drugs
News & EventsFDA NEWS RELEASEFor Immediate Release: Feb. 28, 2012
Media Inquiries: Erica Jefferson, 301-796-4988,
Consumer Inquiries: 888-INFO-FDAFDA announces safety changes in labeling for some cholesterol-lowering drugs 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 clinical y 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 fol owing symptoms
of liver problems: unusual fatigue or weakness; loss of appetite; upper bel y pain; dark-colored urine;
yel owing of the skin or the whites of the eyes. Certain cognitive (brain-related) effects have been reported with statin use. Statin labels wil now
include information about some patients experiencing memory loss and confusion. These reports
general y have not been serious and the patients’ symptoms were reversed by stopping the statin.
However, patients should stil 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 smal increased risk of
increased blood sugar levels and of being diagnosed with type 2 diabetes mel itus. The labels wil 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 sideeffects associated with statin use to 1. For more information:
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm293623.htm
Press Announcements > FDA announces safety changes in labeling for some cholesterol-lowering drugs
5The 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.
3. /ForConsumers/ConsumerUpdates/ucm293330.htm
4. /NewsEvents/Newsroom/PressAnnouncements/UCM284955
5. /NewsEvents/Newsroom/PressAnnouncements/ucm294477.htm
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm293623.htm
Black Walnut Leaves / Shells Botanical Juglans regia classifications Constituents Tannin, anti-bacterial agents, high in vit C. Properties Acts as an astringent, antibacterial, vermifuge Uses: Infusions of the leaves can be taken internally as a digestive tonic. ery useful in the treatment of diarrhea, infections of the mouth throat and eyes. Internal Inner bark can be u
This document reflects emergingclinical and scientific advances as ABSTRACT: Compounded bioidentical hormones are plant-derived hor- mones that are prepared, mixed, assembled, packaged, or labeled as a drug by a pharmacist and can be custom made for a patient according to a physi- cian’s specifications. Most compounded products have not undergone rigor- ous clinical testing for safety o
Press Announcements > FDA announces safety changes in labeling for some cholesterol-lowering drugs
News & EventsFDA NEWS RELEASEFor Immediate Release: Feb. 28, 2012
Media Inquiries: Erica Jefferson, 301-796-4988,
Consumer Inquiries: 888-INFO-FDAFDA announces safety changes in labeling for some cholesterol-lowering drugs 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.
Press Announcements > FDA announces safety changes in labeling for some cholesterol-lowering drugs
5The 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.