Evolution and revolution in drug labeling: regulation of antiarrhythmic drugs by the Food and Drug Administration 1962-1996.
Between 1962, when the Kefauver-Harris Drug Amendments were passed, and 1996, 20 pharmaceutical compounds were approved and labeled by the FDA as effective antiarrhythmic drugs for some specified cardiac arrhythmia. Drug research and development in the 1970s and 1980s were focused on treatment of premature ventricular beats as a marker for sudden cardiac death and ventricular tachycardia. The Cardiac Arrhythmia Suppression Trial in 1989 irrevocably altered this approach. Recent drug development programs have targeted atrial fibrillation (AF) as epidemiologic data have predicted an increase in the incidence of AF as the United States population ages, and as treating premature ventricular beats has fallen from favor. The FDA, the scientific community, and the pharmaceutical industry have all participated in and been affected by this evolution in drug development.
Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA. ed.pritchett@duke.edu
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D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000266:history* / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000188:drug therapy / Q000453:epidemiology / Q000266:history; D017277:Drug Approval / Q000266:history; D004348:Drug Labeling / Q000266:history* / Q000331:legislation & jurisprudence / Q000639:trends; D049673:History, 20th Century; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history*
D000889:Anti-Arrhythmia Agents