Arrhythmias & electrophysiology

Ventricular Arrhythmias Associated With Over-the-Counter and Recreational Opioids

J Am Coll CardiolPublished Pharmacovigilance study

Authors' conclusion

The nonprescription drugs loperamide and mitragynine are associated with disproportionate reports of life-threatening ventricular arrhythmia in North America.

Study context

Population
Adverse event reports in North American databases (FAERS, CAERS, Canada Vigilance Adverse Reaction (CVAR)), 2015–2021
Comparison
Opioids: ventricular arrhythmia reporting
Outcome
Ventricular arrhythmia reports (FAERS)
Methodological detailsdisproportionality analysis of adverse event reporting databases, FAERS primary analysis, CAERS and CVAR confirmatory, positive control: methadone, negative controls: buprenorphine, naltrexone
  • Disproportionality analysis of adverse event reporting databases
  • FAERS primary analysis
  • CAERS and CVAR confirmatory
  • Positive control: methadone
  • Negative controls: buprenorphine, naltrexone

Main finding

As reported in the abstract

GroupValueProportional reporting ratio (PRR)Chi-squareFatalitiesDeaths
Methadone1,163 events6.6 (95% CI: 6.2-7.0)5,456852 (73%)
Loperamide1,008 events3.2 (95% CI: 3.0-3.4)1,537371 (37%)
Mitragynine46 events8.9 (95% CI: 6.7-11.7)31542 (91%)

Value

Methadone1,163 events
Loperamide1,008 events
Mitragynine46 events

Proportional reporting ratio (PRR)

Methadone6.6 (95% CI: 6.2-7.0)
Loperamide3.2 (95% CI: 3.0-3.4)
Mitragynine8.9 (95% CI: 6.7-11.7)

Chi-square

Methadone5,456
Loperamide1,537
Mitragynine315

Fatalities

Methadone852 (73%)
Loperamide— not stated in the abstract
Mitragynine— not stated in the abstract

Deaths

Methadone— not stated in the abstract
Loperamide371 (37%)
Mitragynine42 (91%)

Further findings

Confirmatory databases (CVAR, CAERS)

Signals similar in CVAR and CAERS

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Ventricular Arrhythmias Associated With Over-the-Counter and Recreational Opioids. J Am Coll Cardiol. Published 13 June 2023. doi:10.1016/j.jacc.2023.04.009

Composed by AI from the published abstract and checked against it. How Briefs are made →

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