Estimating the number of sudden cardiac deaths attributable to the use of domperidone in France

Pharmacoepidemiol Drug Saf. 2015 May;24(5):543-7. doi: 10.1002/pds.3771. Epub 2015 Mar 31.

Abstract

Purpose: The aim of this study was to estimate of the number of sudden cardiac deaths attributable to the use of domperidone in France in 2012 METHODS: Computation of the attributable fraction, function of the increase in risk of sudden cardiac death induced by domperidone and of the exposure prevalence. Multiplying the attributable fraction by the risk of sudden cardiac death in the French population gives an estimation of the number of sudden cardiac deaths attributable to domperidone.

Results: The use of domperidone in France is the cause of 231 deaths per year in the population aged 18 years or over.

Conclusions: This risk should be taken into consideration by clinicians when prescribing a drug which provides a minor benefit.

Keywords: adverse effect; domperidone; pharmacoepidemiology; sudden cardiac death; surveillance.

MeSH terms

  • Antiemetics / administration & dosage
  • Antiemetics / adverse effects*
  • Antiemetics / therapeutic use
  • Data Interpretation, Statistical
  • Databases, Factual
  • Death, Sudden, Cardiac / epidemiology*
  • Death, Sudden, Cardiac / etiology
  • Domperidone / administration & dosage
  • Domperidone / adverse effects*
  • Domperidone / therapeutic use
  • Drug Utilization Review
  • Female
  • France
  • Humans
  • Male
  • Odds Ratio
  • Risk

Substances

  • Antiemetics
  • Domperidone