The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women

J Popul Ther Clin Pharmacol. 2013;20(2):e161-2. Epub 2013 Jul 14.

Abstract

The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety. After thirty years of being orphaned from an FDA-labeled drug for the most common medical condition in pregnancy, American women and their health care providers have a therapeutic solution that is likely to positively impact millions of women each year. This review highlights the milestones of this antiemetic agent over the last 40 years.

MeSH terms

  • Antiemetics / adverse effects
  • Antiemetics / therapeutic use*
  • Delayed-Action Preparations
  • Dicyclomine
  • Doxylamine / adverse effects
  • Doxylamine / therapeutic use*
  • Drug Approval
  • Drug Combinations
  • Drug Labeling
  • Female
  • Humans
  • Morning Sickness / drug therapy*
  • Morning Sickness / epidemiology
  • Pregnancy
  • Pyridoxine / adverse effects
  • Pyridoxine / therapeutic use*
  • United States
  • United States Food and Drug Administration

Substances

  • Antiemetics
  • Delayed-Action Preparations
  • Drug Combinations
  • dicyclomine, doxylamine, pyridoxine drug combination
  • Dicyclomine
  • Doxylamine
  • Pyridoxine