FDA sounds alert on statin medications

Safety concerns surfaced Tuesday about the popular class of medications known as statins when federal regulators announced small but increased risks for diabetes and memory loss for people on the drugs.

Statins lower the so-called bad form of cholesterol, decreasing the risk of heart attacks and strokes. Experts say the benefits of statins still outweigh the risks.

"These drugs are so beneficial we don't want to create alarm," said Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in Mineola, referring to the warnings from the U.S. Food and Drug Administration.

"Statins have been used for over 30 years and because of them we have seen a steady decline in cardiovascular disease," he said.

The drugs include some of the best-known pharmaceutical brand names on the market: Lipitor, Zocor, Mevacor, Crestor, Pravachol and Lescol. Numerous generics are also routinely sold.

Tens of millions of people nationwide are estimated to be on the medications, which collectively net billions annually for the pharmaceutical industry. Major manufacturers did not return Newsday's inquiries Tuesday about the warnings.

The FDA aimed its alert at physicians and consumers. The agency will now require pharmaceutical companies to include warnings on package labeling about statins' potential to raise blood sugar and induce memory loss.

Dr. Mary Parks, director of the FDA's division of metabolism and endocrinology products, said the new warnings follow a series of studies about the drugs.

"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," she said.

A separate group of statins with an additional active ingredient, such as niacin, are also part of the alert. Combination products include Advicor, Simcor and Vytorin.

Experts say despite the warnings, statins are beneficial and people should continue to take it as prescribed.

Statins, studies have shown, help reduce the likelihood of heart attacks and strokes by blocking the production of low-density lipoprotein -- LDL cholesterol -- in the liver.

Marzo said statins can increase the risk of diabetes by about 10 percent. For patients who already have the condition, he said the risk of a small rise in blood sugar pales in comparison to the cardiovascular risks diabetics face.

The new FDA labeling information about diabetes is considered to be stricter than its caution about memory loss.

Marzo said normal cognition resumes when patients are taken off statins. He added that patients should stop the medication under a physician's guidance.

Marzo said statins, in combination with a healthy diet and regular exercise, have been very effective in reducing the risk of cardiovascular disease.

FINDINGS

Memory loss possible, but most symptoms have not been serious.

Increases in blood sugar levels (hyperglycemia) possible; small increased risk of type 2 diabetes also noted.

No need for routine monitoring of liver enzymes. But patients should notify their doctors of unusual fatigue, dark-colored urine or yellowing of the skin or whites of the eyes.

Source: U.S. Food and Drug Administration