Eplerenone: a new aldosterone receptor antagonist--are the FDAs restrictions appropriate?

Eplerenone is a new aldosterone receptor antagonist that will be used in the treatment of hypertension. Like spironolactone, it is a compound that can be associated with the development of hyperkalemia. Therefore, the same prescription considerations that are applied to spironolactone should be directed to its use. Unfortunately, the label for eplerenone will place more stringent restrictions on its use than is the case for spironolactone. The basis for the multiple contraindications to the use of eplerenone is primarily that of concern for the development of hyperkalemia. This may occur with eplerenone, as has been the case with spironolactone. The presumption in the prescribing information that certain patient subsets, such as diabetics with microalbuminuria and/or patients with mild renal failure, would be highly prone to developing clinically relevant hyperkalemia with eplerenone is not, however, grounded in fact. The favorable experience with spironolactone is important. It should provide us with the landmarks for advancing knowledge on the role of newer aldosterone receptor antagonists in disease state management and one would think, help in establishing criteria for the safe use of new compounds. New compounds in a drug class typically provide advantages over earlier entries into a drug class but not if regressive labeling has occurred. Time and additional clinical experience with eplerenone will establish its safety profile and determine if the original label for this compound was correct.