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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