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Invited Commentary
January 2016

Off-label Drug Use and Adverse Drug Events: Turning up the Heat on Off-label Prescribing

Author Affiliations
  • 1Pharmacy Benefits Management Services, US Department of Veterans Affairs, Hines, Illinois
  • 2Division of General Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 3Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania
  • 4Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania
JAMA Intern Med. 2016;176(1):63-64. doi:10.1001/jamainternmed.2015.6068
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    1 Comment for this article
    Evidence, not FDA approval, reduced adverse events
    David L. Keller | none
    The study by Eguale et al demonstrated that off-label prescribing is not associated with increased adverse drug events (ADEs) when supported by strong scientific evidence. Since off-label prescriptions backed by strong evidence are just as safe as prescriptions for FDA-approved indications, the FDA ban on promotion of the former denies patients the benefits of safe and scientifically proven medications. The focus must shift to suppression of off-label prescribing only when it is not backed by strong evidence. So says the evidence.<br/><br/>