Pharma

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 […]

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.

“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.

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