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Almost one-third of FDA-approved therapeutics had postmarket safety events
Nearly one-third of the 222 new pharmaceuticals and biologics approved by the FDA from 2001 through 2010 were subject to a postmarket safety event such as issuance of a safety communication, boxed warning, or withdrawal, according to research recently published in JAMA.“Given the inherent limitations of premarket clinical evaluation for drug safety, there may be opportunities to enhance patient safety if factors associated with postmarketsafety events could be identified at the time of FDA approval,” Nicholas S. Downing, MD, department of medicine, Brigham and Women’s Hospital, Boston, and colleagues wrote. (Read more...)