From the Center for Health Policy Research, the George Washington University Medical Center, Washington, DC (Mr Moore); the Cardiovascular Health Research Unit, the Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle (Dr Psaty); and the Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC (Dr Furberg).
LAST SEPTEMBER, the diet drugs fenfluramine and dexfenfluramine were
withdrawn after the Food and Drug Administration (FDA) reviewed echocardiographic
studies indicating heart valve abnormalities in 31% of the patients tested.1 While the FDA acted within days of receiving the heart
valve data, fenfluramine had been approved 24 years earlier.2
In December 1997, the popular nonsedating antihistamine terfenadine was withdrawn
because a safer alternative existed without terfenadine's risk of potentially
lethal cardiac arrhythmia.3 Terfenadine had
been on the market for 12 years.
Moore TJ, Psaty BM, Furberg CD. Time to Act on Drug Safety. JAMA. 1998;279(19):1571-1573. doi:10.1001/jama.279.19.1571