May 20, 1998

Time to Act on Drug Safety

Author Affiliations

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).

JAMA. 1998;279(19):1571-1573. doi:10.1001/jama.279.19.1571

LAST SEPTEMBER, the diet drugs fenfluramine and dexfenfluramine were withdrawn after the Food and Drug Administration (FDA) reviewed echocardiographic studies indicating heart valve abnormalities in 31% of the patients tested.1 While the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had been approved 24 years earlier.2 In December 1997, the popular nonsedating antihistamine terfenadine was withdrawn because a safer alternative existed without terfenadine's risk of potentially lethal cardiac arrhythmia.3 Terfenadine had been on the market for 12 years.

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