Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014

Clin Pharmacol Ther. 2018 Aug;104(2):390-400. doi: 10.1002/cpt.944. Epub 2017 Dec 20.


We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles.

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Drug Approval*
  • Drug Labeling*
  • Drug-Related Side Effects and Adverse Reactions / diagnosis
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Humans
  • Patient Safety
  • Product Surveillance, Postmarketing*
  • Retrospective Studies
  • Risk Assessment
  • Safety-Based Drug Withdrawals*
  • Time Factors
  • United States / epidemiology
  • United States Food and Drug Administration*