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July 21, 2015

The Safety of Prescription Drugs

Author Affiliations
  • 1Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 2The Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
  • 3Harvard Medical School, Boston, Massachusetts
JAMA. 2015;314(3):233-234. doi:10.1001/jama.2015.7151

Drug safety challenges have bedeviled the US Food and Drug Administration (FDA) for many years, and for good reason. The phased approach to drug development is primarily geared to establishing evidence of efficacy. Hundreds, perhaps thousands, of patients are exposed to an investigational drug in clinical trials. However, it may not be until after approval, when the medication is used by as many as hundreds of thousands of patients, that rare but serious adverse events appear or there is sufficient statistical power to determine whether the drug increases rates of more common potential adverse outcomes, such as cardiovascular disease or diabetes.

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