FDA’s easing of liver monitoring requirements for statins leads a clinical study design expert to predict a better chance of success for switching cholesterol-lowering drugs like Pfizer Inc.’s Lipitor OTC, but some say the change won’t improve the odds for a statin switch.
The new class labeling FDA published Feb. 28 eliminates the statement that liver function tests should be performed prior to and at 12 weeks following both the initiation of therapy...