After years of reports and debate about the extent to which cholesterol-lowering meds can lead to memory loss, the FDA has asked drugmakers to add information about 'non-serious' cognitive side effects to warning labels. At the same time, information is also being added about the possibility that statins can lead to diabetes, citing studies showing an increased risk.
The move may inflame the debate over the extent to which statins should be taken by people who are not at high risk for cardiovascular problems. Just the same, the agency "continues to believe that the cardiovascular benefits of statins outweigh these small increased risks," according to a statement. The drugs include Pfizer's Lipitor and AstraZeneca's Crestor.
Meanwhile, the FDA also removed a requirement for routine monitoring of liver enzymes because liver injury is rare and regular monitoring does not appear to be effective in detecting or preventing serious liver injury. And the labeling for lovastatin, originally marketed as Mevacor by Merck, was extensively updated with new contraindications (here is the FDA statement).