Are drug labels static or dynamic?

Clin Pharmacol Ther. 2013 Sep;94(3):302-4. doi: 10.1038/clpt.2013.109.

Abstract

Understanding drug metabolism is essential for identifying drug-drug interactions (DDIs). As new data concerning a drug's pharmacokinetics arise, updates to drug labels and administration procedures should rapidly follow. However, the US Food and Drug Administration (FDA) has inconsistently updated drug labels, based on new research findings (i.e., in peer-reviewed publications). In this Commentary, we highlight recent findings on the metabolism of imatinib and argue for a more stringent protocol for updating drug labels.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / pharmacokinetics
  • Aryl Hydrocarbon Hydroxylases / antagonists & inhibitors
  • Benzamides / adverse effects
  • Benzamides / pharmacokinetics
  • Cytochrome P-450 CYP2C8
  • Cytochrome P-450 CYP3A
  • Cytochrome P-450 CYP3A Inhibitors
  • Drug Interactions
  • Drug Labeling / trends*
  • Humans
  • Imatinib Mesylate
  • Piperazines / adverse effects
  • Piperazines / pharmacokinetics
  • Pyrimidines / adverse effects
  • Pyrimidines / pharmacokinetics
  • United States
  • United States Food and Drug Administration / organization & administration*

Substances

  • Antineoplastic Agents
  • Benzamides
  • Cytochrome P-450 CYP3A Inhibitors
  • Piperazines
  • Pyrimidines
  • Imatinib Mesylate
  • Aryl Hydrocarbon Hydroxylases
  • CYP2C8 protein, human
  • Cytochrome P-450 CYP2C8
  • Cytochrome P-450 CYP3A
  • CYP3A4 protein, human