FDA: Diabetes Warning for Statins
On February 28th 2012, the FDA mandated that cholesterol-lowering drugs called statins must carry warnings about increased risks of elevated blood sugar, which could be dangerous for diabetics. The agency also noted the risk of temporary memory problems as a result of taking the drugs. The medications on the FDA list for label changes include Lipitor, Lescol, Livalo, Pravachol, Crestor, Zocor, and Mevacor. In addition, warnings about the possibility of dangerous drug interactions were added to the Mevacor label.
However, the FDA simultaneously removed a long-standing recommendation that patients taking statins should have regular liver function tests. The new recommendation is for a single liver function test before starting a patient on a statin. Most important, the FDA reported that in spite of the new warnings, it "continues to believe that the cardiovascular benefits of statins outweigh these small increased risks."
ABC News/MedPage Today interviewed The Cleveland Clinic's Steven Nissen, MD, noting that he is "often a critic of the FDA" but that this time around he said that "these are reasonable and prudent recommendations. I am pleased that FDA did not overstate the diabetes and cognitive function risks. Both problems are uncommon and don't diminish the importance of statins in cardiovascular protection. For the vast majority of patients, the benefits far outweigh the risks." As for the liver monitoring, Nissen said the FDA's decision "will help to allay public apprehension about the liver safety of statins."