Nitrates, Package Inserts, and the Food and Drug Administration
A Clinical Paradox
- Jonathan Abrams, MD
Since this article does not have an abstract, we have provided the first 150 words of the full text.
Excerpt
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.1 Yet 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.2,3 Finally, 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
Footnotes
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Reprint requests to Division of Cardiology, University of New Mexico School of Medicine, Albuquerque, NM 87131 (Dr Abrams).
