The association between domperidone and ventricular arrhythmia in the postpartum period

Pharmacoepidemiol Drug Saf. 2016 Oct;25(10):1210-1214. doi: 10.1002/pds.4035. Epub 2016 Jun 14.

Abstract

Purpose: The aim of this study is to examine the relationship between domperidone (commonly used off-label for lactation stimulation), ventricular arrhythmia and all-cause mortality during the postpartum period.

Methods: This is a retrospective, population-based cohort study of all women with a live birth between 1 January 2002 and 31 December 2011 in British Columbia, Canada. Cox proportional hazards models, yielding hazard ratios (HRs), were used to estimate the risk of hospitalization for ventricular arrhythmia associated with domperidone exposure within six months postpartum.

Results: The study population consisted of 225 532 women with 320 351 live births. There was only one death during the six-month postpartum period among the study population, and thus we did not perform any analyses of all-cause mortality. We identified 21 hospitalizations for ventricular arrhythmia. Adjusting for age, smoking and prior history of ventricular arrhythmia and cardiovascular disease, the risk of ventricular arrhythmia hospitalization was approximately double among those exposed to domperidone, but the results were not statistically significant (HR = 2.25, 95%CI 0.84-6.01). Adjustment for body mass index in the 74% of women for whom it was known further reduced the association (HR = 1.69, 95%CI 0.48-5.96).

Conclusions: We found a possible association between exposure to domperidone and hospitalization for ventricular arrhythmia among a cohort of women who have recently given birth. Future studies are needed to confirm this association. Copyright © 2016 John Wiley & Sons, Ltd.

Keywords: domperidone; pharmacoepidemiology; postpartum; ventricular arrhythmia.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Arrhythmias, Cardiac / chemically induced*
  • Arrhythmias, Cardiac / epidemiology
  • British Columbia
  • Cohort Studies
  • Domperidone / administration & dosage
  • Domperidone / adverse effects*
  • Dopamine Antagonists / administration & dosage
  • Dopamine Antagonists / adverse effects*
  • Female
  • Hospitalization / statistics & numerical data
  • Humans
  • Postpartum Period*
  • Pregnancy
  • Proportional Hazards Models
  • Retrospective Studies
  • Risk Factors

Substances

  • Dopamine Antagonists
  • Domperidone

Grants and funding