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Medication Management

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FDA announces safety changes in labeling for some cholesterol-lowering drugs


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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 nationís food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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