Physicians can anticipate three key safety changes to the labels of several cholesterol-lowering drugs, according to a Food and Drug Administration announcement on Feb. 28.
The changes affect the following drugs: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Three combination products are also included: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
The safety information on the labels will reflect changes with regard to the monitoring of liver enzymes, reports of certain cognitive effects, and reports of hyperglycemia with statin use.
The agency no longer recommends periodic monitoring of liver enzymes. "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," according to a press statement. Instead, the agency now recommends that liver enzyme tests be performed before starting statin therapy, and as clinically indicated thereafter.
In addition, labels will now include information about some patients who have experienced memory loss and confusion. The agency noted that these reports generally have not been serious and the patients’ symptoms were reversed by stopping use of the statin. In addition, there have been studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of type 2 diabetes diagnosis. The labels will now warn health care professionals and patients of this potential risk.
More extensive safety changes have been made to the lovastatin label. The changes will note that some medicines may interact with lovastatin, thereby increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, the use of certain medicines is contraindicated with Mevacor (lovastatin), including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.
Health care professionals and patients can report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or by downloading a form, or by calling 1-800-332-1088 to request a reporting form, and then completing and returning it to the address on the preaddressed form or submitting it by fax to 1-800-FDA-0178.
For more information on the changes, visit www.fda.gov/Drugs/DrugSafety/ucm293101.htm.