Nitrates, Package Inserts, and the Food and Drug Administration

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Abstract
A DILEMMA exists regarding the usefulness of long-acting nitrate preparations in patients with angina pectoris or congestive heart failure and the present Food and Drug Administration approved package inserts (regulatory monographs), outlining nitrate dosage regimens and clinical indications. This group of drugs, whether given orally or topically, has been documented to be bioavailable and clinically effective for four to six hours or longer.1Yet the FDA continues to classify all oral long-acting nitrate preparations as being only "possibly effective." In addition, maximal dosages currently recommended by the pharmaceutical manufacturers are considerably smaller than the amounts found to be safe, necessary, and efficacious in a variety of recent investigations.2,3Finally, promotional literature, including the package insert, may not recommend nitrates for use in vasodilator therapy of congestive heart failure. No pharmaceutical company has yet submitted a New Drug Application to the FDA for use of any long-acting nitrate in

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