The FDA today announced important new changes to the safety language on the labels of statins:
Routine periodic monitoring of liver enzymes is no longer recommended. Serious liver injury associated with statins is “rare and unpredictable in individual patients” and “routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect,” according to the FDA. The FDA now says that liver enzyme tests only need to be performed before starting statin therapy and “as clinically indicated thereafter.”
Memory loss and confusion will now be included in the label. But, the FDA notes, reports about the cognitive effects of statins have usually “not been serious and the patients’ symptoms were reversed by stopping the statin.” In a story published on Forbes, Matt Herper writes that the “new labeling will lead patients and doctors to take memory issues on the drugs more seriously, and it will also lead patients to link normal lapses of memory to their drugs.”
The increased risk of hyperglycemia and type 2 diabetes will be mentioned in the label. The label will now reflect data showing the small increased risk for type 2 diabetes in people taking statins.
The FDA is also making specific recommendations about lovastatin, noting that when used with some other drugs lovastatin can increase the risk of muscle injury.
Here is the FDA press release:
|FDA 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:
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
|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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