Reporting of clozapine-induced gastrointestinal hypomotility and factors associated with fatal outcomes in Canada: A pharmacovigilance database study

Psychiatry Res. 2020 Aug:290:113048. doi: 10.1016/j.psychres.2020.113048. Epub 2020 May 16.

Abstract

Clozapine-induced gastrointestinal hypomotility (CIGH) is poorly understood and potentially life-threatening. Herein, we present trends of CIGH annual reporting and explore factors associated with a fatal outcome using 25-years of pharmacovigilance data in Canada. Since 1993, the number of CIGH reports increased 22-fold but the proportion of fatal reports remained relatively stable. Fatal reports of CIGH were associated with older age but not sex, clozapine dose, or clozapine duration. Concomitant use of medications used to treat CIGH (lactulose, docusate sodium) and its associated pain/discomfort (acetaminophen, lorazepam) were more commonly reported in fatal cases. Confirmatory and prospective studies of CIGH are warranted.

Keywords: Canada; Clozapine; Gastrointestinal Hypomotility.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antipsychotic Agents / adverse effects*
  • Antipsychotic Agents / therapeutic use
  • Canada / epidemiology
  • Clozapine / adverse effects*
  • Clozapine / therapeutic use
  • Databases, Factual / trends
  • Female
  • Gastrointestinal Diseases / chemically induced*
  • Gastrointestinal Diseases / diagnosis
  • Gastrointestinal Diseases / mortality*
  • Gastrointestinal Motility / drug effects*
  • Gastrointestinal Motility / physiology
  • Humans
  • Male
  • Middle Aged
  • Pharmacovigilance*
  • Prospective Studies

Substances

  • Antipsychotic Agents
  • Clozapine