Time to Act on Drug Safety
- Thomas J. Moore;
- Bruce M. Psaty, MD, PhD;
- Curt D. Furberg, MD, PhD
- 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).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- adverse drug reaction reporting systems
- drug approval
- pharmaceutical preparations
- safety
- united states food and drug administration
LAST SEPTEMBER, the diet drugs fenfluramine and dexfenfluramine were withdrawn after the Food and Drug Administration (FDA) reviewed echocardiographic studies indicating heart valve abnormalities in 31% of the patients tested.1 While the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had been approved 24 years earlier.2 In December 1997, the popular nonsedating antihistamine terfenadine was withdrawn because a safer alternative existed without terfenadine's risk of potentially lethal cardiac arrhythmia.3 Terfenadine had been on the market for 12 years.
Discovering new dangers of drugs after marketing is common. Overall, 51% of approved drugs have serious adverse effects not detected prior to approval.4 Merely discovering adverse effects is not by itself sufficient to protect the public. Each year prescription drugs injure 1.5 million people so severely they require hospitalization and 100000 die, making prescription drugs a leading cause of death in the United States.5 …
