FDA adds diabetes warning to cholesterol-lowering medications

The Food and Drug Administration (FDA) is adding a diabetes risk warning to the safety information on cholesterol-lowering drugs called statins.

When used with diet and exercise, statins help to lower a person's “bad” cholesterol (low-density lipoprotein cholesterol), according to the FDA.

More than 20 million Americans take statins to reduce the risk of heart attack and heart disease, according to IMS Health.

Some patients have reported increases in blood sugar levels, or hyperglycemia, with statin use. The FDA cites previous studies showing that patients taking statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes.

A 2010 study published in the journal Lancet found that statins can raise the risk of diabetes by 9 percent, according to a Reuters report.

Some patients also have reported memory loss and confusion with statin use. The symptoms are not serious and were reversed when the patients stopped taking the medication. The FDA will add a warning about these potential cognitive effects as well.

“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure then that these medications continue to provide an important health benefit of lowering cholesterol,” said Mary Parks, MD of the FDA's Center for Drug Evaluation and Research.

Statins are marketed as 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).

Lipitor is the world's all-time biggest selling prescription medicine, according to the Reuters report.

Some 25.8 million Americans live with diabetes. Type 2 diabetes affects about 95 percent of these patients.

People with diabetes are twice as likely to have heart disease or a stroke as someone without diabetes, according to the National Diabetes Information Clearinghouse. People with diabetes also tend to develop heart disease or have strokes at an earlier age than other people.

Sources: Food and Drug Administration, Reuters, National Diabetes Information Clearinghouse