FDA's new statin label warning about diabetes risk may have little effect

In evaluating the new warning U.S. regulators are issuing on statin prescription labels, many physicians are likely to take the view that high cholesterol poses a greater risk to their patients than potential side effects like diabetes, memory loss and muscle pain.

In an interview with Reuters, Steven Nissen, the head of cardiology with the Cleveland Clinic, said: "There are few drugs that have saved as many lives as statins and we don't want to throw the baby out with the bathwater here."

The U.S. Food and Drug Administration cited recent clinical research as a reason behind the new warning, according to media reports.

The Journal of American Medical Association published an article last year that shows a connection between large doses of statins and diabetes. So did British medical journal The Lancet.

Statins like Lipitor, developed by New York-based Pfizer (NYSE:PFE), and Crestor, developed by Astra Zeneca (NYSE:AZN) in Delaware, have generated tens of billion of dollars for the pharmaceutical companies because so many people take them.

Dr. Mary Parks, a director in the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, cautioned prescribing physicians and patients against overreacting to the new warning, in a statement from the U.S. regulator.

The FDA continues to recommend health care professionals perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter.

Read the complete FDA alert here.

"We want healthcare 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.

"When we looked at these reports they ran the gamut - memory loss, memory impairment, confusion - and they were occurring anywhere from one day after initiation of the statin to years after initiation." Egan said. "We could not identify if it was age specific because it was across a range of age groups. We did not see it occurring as a drug interaction, where patients were also taking other medications that were reacting with the statin to cause the confusional state. But we really want to get the message out there that we do not consider this a major problem, and certainly it does not outweigh the tremendous benefits of statin therapy."

James Howard, director of the Lipid Clinic at MedStar Washington Hospital Center in Washington, DC, says the new changes are a real step forward. He says the concern over an increased risk of diabetes is valid but not a reason to shun statins.

"The diabetic has a significant increased risk for heart disease, and the most clearly demonstrated therapy that will affect that is to control their cholesterol and their blood pressure," Howard said. "Statins are very important in diabetics to reduce their risk of heart attack and stroke. So the benefit they will receive in that reduction in risk far outweighs the risk of developing diabetes. It's a small risk, but it's a lot of people."