Is there such a thing as a 'lope' dope? Analysis of loperamide-related European Medicines Agency (EMA) pharmacovigilance database reports.

Fabrizio Schifano,Stefania Chiappini,Y-H Taguchi

doi:10.1371/journal.pone.0204443

Fabrizio Schifano, Stefania Chiappini + Show 1 more

Open Access

https://doi.org/10.1371/journal.pone.0204443

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Journal: PloS one	Publication Date: Oct 4, 2018
Citations: 33	License type: CC BY 4.0

Affiliation: University of Hertfordshire

Abstract

BackgroundAmong over-the-counter (OTC) drugs, loperamide has recently emerged for its potential of misuse and cardiotoxicity issues. Hence, we aimed here at assessing the loperamide-related cases being reported to the EMA's EudraVigilance (EV) database.MethodsAll spontaneous EV reports relating to loperamide misuse/abuse/dependence/withdrawal and cardiotoxicity issues were here retrieved, performing a descriptive analysis.FindingsDuring the years 2005–2017, EV collected a number of 1,983 (out of a total of 7,895; 25.11%) loperamide-related misuse/abuse/dependence/withdrawal adverse drug reaction (ADR) reports, with a progressively increasing trend since 2014. Most cases were classified as drug use disorder (37.4%) or intentional overdose (25.4%). Loperamide was used on its own in 41.9% of cases; remaining, polydrug, cases included antidepressants; benzodiazepines; and other OTCs. Some 1,085 (1,085/7,895 = 13.7%) cardiovascular ADRs were reported, being conduction abnormalities and EKG alterations the most frequently identified.ConclusionsEV data may support the levels of concern relating to loperamide potential of abuse and associated cardiotoxicity issues.

Highlights

In being perceived to be safe and appropriate for use without the supervision of a healthcare professional, over-the-counter (OTC) medicines are meant to be delivered without the need for a prescription
EV data may support the levels of concern relating to loperamide potential of abuse and associated cardiotoxicity issues
Consistent with this, Eggleston et al [23] analyzed the January 2008–March 2016 loperamide abuse cases reported to the National Poison Database System (NPDS) and the New York City Poison Control Center (NYCPCC)

Summary

Findings

During the years 2005–2017, EV collected a number of 1,983 (out of a total of 7,895; 25.11%) loperamide-related misuse/abuse/dependence/withdrawal adverse drug reaction (ADR) reports, with a progressively increasing trend since 2014. Most cases were classified as drug use disorder (37.4%) or intentional overdose (25.4%). Loperamide was used on its own in 41.9% of cases; remaining, polydrug, cases included antidepressants; benzodiazepines; and other OTCs. Some 1,085 (1,085/7,895 = 13.7%) cardiovascular ADRs were reported, being conduction abnormalities and EKG alterations the most frequently identified

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