Updated US Food and Drug Administration (FDA) warnings that use of cholesterol-lowering statins can increase the risk of developing diabetes, liver injury, cognitive problems, and muscle injury for some patients have renewed criticism about overuse of this class of medications.
Last week, the FDA announced changes to the labels of statin medications, which include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, and combination products containing these drugs. The label changes indicate that these products may be associated with memory loss or confusion, an increased risk of developing type 2 diabetes, and increased risk of muscle injury when used in combination with drugs for the treatment of HIV or hepatitis C virus infection.
The agency noted that it found evidence of mild and reversible memory loss and confusion from reports in its Adverse Events Reporting System and in the medical literature. Additionally, the agency noted that a large clinical trial and a meta-analysis reported an increased risk of diabetes among statin users.
“FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks,” the agency stated.
However, in an editorial in the New York Times on Sunday, prominent cardiologist Eric J. Topol, MD, professor of genomics at the Scripps Research Institute in La Jolla, California., argued that the magnitude of the risk of diabetes is large enough to be a concern, particularly for individuals taking statins to prevent a first heart attack or other cardiovascular problem. Topol said the data suggest that 1 in 200 patients taking one of the most potent statins—simvastatin, atorvastatin, and rosuvastatin—will develop diabetes. For a patient with heart disease or a previous stroke, the benefits still outweigh the risks, he said, but he questioned the value of statins for most users of statins, who take them in the hopes of preventing such events. Only about 2 per 100 such individuals will benefit from taking the drugs.
“The problem of statin-induced diabetes cannot be underplayed while the country is being overdosed,” he stated.