Federal regulators are updating the safety labeling of cholesterol fighting statins, some of the most widely used medications in the United States.
The U.S. Food and Drug Administration (FDA) said in a Safety Announcement that the agency has approved important safety changes to the labeling of the entire class of cholesterol-lowering medications known as statins.
ABC World News reports that one in every four Americans over age 45 takes a statin.
Consumers may be taking a single-ingredient statin sold under the brand name Altoprev (lovastatin extended-release), Crestor (rosuvastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Livalo (pitavastatin), Mevacor (lovastatin), Pravachol (pravastatin) or Zocor (simvastatin). Statins are also marketed as combination products sold under the brand names Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
Changes made to statin labeling include:
- Use of statins is associated with serious liver injury. The FDA approved removal of an advisory on the label for the need of routine periodic monitoring of liver enzymes after finding the testing does not detect or prevent serious liver injury. The FDA now recommends doctors perform liver enzyme testing before a patient begins statin use and as clinically indicated thereafter.
- There are reports of cognitive (brain-related) side effects with statin use. A warning has been added to the label about risk of confusion and memory loss, that these side effects reversed when patients stopped taking the drug, and for patients to report these side effects to their doctor.
- Statin use can cause an increase in blood sugar levels (hyperglycemia). A warning was added to the labeling about risks of increased blood sugar levels and being diagnosed with type 2 diabetes mellitus.
- There is risk of muscle damage resulting from drug interactions with lovastatin ingredient statins (Mevacor and Advicor). Lovastatin labeling will include a warning about risk of muscle injury (myopathy/rhabdomyolysis) when taken with certain other medications, such as HIV protease inhibitors and certain bacterial and fungal infection treatment medications.
“The value of statins in preventing heart disease has been clearly established,” said Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP) in a Consumer Update. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”
The American Diabetes Association urged diabetics not to stop taking their statin medications without talking to their doctor first because it could raise their risk of diabetes-related heart attacks.
“Every drug has its risks and benefits, and with statins the risk is small and can be managed,” Vivian Fonseca, MD, President, Medicine & Science of the American Diabetes Association said in a release. He adds, “On the other hand, people with diabetes, can receive great benefit from taking these medications. They’ve been proven to prevent heart attacks and prolong life.”