Safety events common for pharmaceuticals and biologics after FDA approval
3 institutional releases
Published in JAMA · View the paper (DOI)
Between 2001 and 2010, nearly a third of FDA-approved pharmaceuticals and biologics experienced postmarket safety events. These events, including withdrawals and boxed warnings, affect patient care and decision-making. Postmarket risks are often only apparent in larger patient populations and longer durations.
Coverage from 3 institutions
- Safety events common for pharmaceuticals and biologics after FDA approval JAMA Network · May 9, 2017 · first to report
- Nearly 1 in 3 drugs found to have safety concerns after FDA approval Brigham and Women's Hospital · May 9, 2017
- New safety concerns identified for 1 in 3 FDA-approved drugs Yale University · May 9, 2017