Statin medications will now display an additional label, one that warns users that these cholesterol-lowering drugs may raise blood sugar levels and cause memory loss. The FDA announced the latest change while still affirming that statins significantly reduce the risk of heart attack and heart disease; the new information, the agency says, should not scare people away from the drugs.
But that s exactly what it will accomplish, says ACSH's Dr. Gilbert Ross. Given the huge burden of coronary artery disease, and the proven benefits of statins in secondary prevention, I feel that the FDA warning will do much more harm than good.
The FDA based its decision on previous studies demonstrating that people taking statins may have a small increased risk of higher blood sugar levels and of developing type 2 diabetes.
However, in a recent article in Medscape Internal Medicine, Dr. Michael Mogadam, associate professor at the Cardiothoracic Institute at George Washington University Medical Center, argues that there is no clear or plausible mechanism by which statins might raise blood glucose levels. He further states that observational studies, such as the ones the FDA used for its latest decision, cannot establish causation.
Although the agency is adding a new warning, the FDA will also be removing an older one: Routine periodic monitoring of liver enzymes will no longer be required, the agency says, since the practice has not been shown to be effective in detecting or preventing serious liver injury, which is a rare side effect.
Too bad the same logic wasn t applied when the FDA decided to add the latest hyperglycemia warning label, ACSH s Dr. Ruth Kava notes.