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

Schifano, Fabrizio; Chiappini, Stefania

doi:10.1371/journal.pone.0204443

Cited by 37 publications

(62 citation statements)

References 44 publications

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“…Adverse events associated with loperamide from 1975 to 2018 were analyzed by the UK Regulating Medicines and Healthcare Products Regulatory Agency. The same number of adverse event reports occurred from 1975 to 2013 as were seen from 2014–2017 . In the United States (Food and Drug Administration Adverse Event Reporting System), 12,851 loperamide cases were reported from 1977–2018.…”

Section: Loperamide Adverse Eventsmentioning

confidence: 78%

“…A recent summary of case reports comes from the European Medicines Agency pharmacovigilance database . Over the years 2005 to 2017 there were 10,991 cases in which loperamide was used or suspected to be used, and of these, 7895 were more closely evaluated.…”

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

“…The incidences of adverse events are given in Figure and represent mostly conduction and respiratory‐related adverse events. Of the 305 fatal adverse events, half were with the sole use of loperamide and half with polypharmacy …”

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

“…The percentage of loperamide adverse events falling into select categories . “Other arrhythmias” indicate mostly ventricular arrhythmias; “ECG alterations,” mostly QTc and QRS interval prolongation; loss of consciousness could be neurological, respiratory, or cardiovascular.…”

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

“…Case frequency started to increase in 2007 and peaked in both 2015 and 2017 with 2019 and 2010 cases, respectively. From the total 12,851 cases, 1204 were strongly associated with loperamide abuse, and 56% of the adverse events were serious, frequently cardiovascular in nature, and led to 252 fatalities …”

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

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Loperamide: A Readily Available but Dangerous Opioid Substitute

White

2019

The Journal of Clinical Pharma

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The antidiarrheal over‐the‐counter drug loperamide is increasingly being used to control opioid withdrawal or for opioid abuse. Taking many times above the normally recommended dose is dangerous with cardiovascular, respiratory, and neurological adverse events. Cytochrome P‐450 (CYP)2C8, CYP3A, and P‐glycoprotein inhibitors can increase the plasma and central nervous system concentrations and radically alter the risk profile of loperamide. Online forums suggest using over‐the‐counter metabolic enzyme blockers to enhance the effects. Public health options include switching over‐the‐counter loperamide to blister packs (the FDA‐preferred method), making loperamide only available by prescription, or moving the product behind the pharmacy counter. Although naloxone may ameliorate the neurological and respiratory adverse events, it is ineffective at reversing loperamide‐induced arrhythmias. Even magnesium might provide less efficacy in loperamide‐induced Torsade de Pointes necessitating the use of cardiac pacing and electrical cardioversion.

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Section: Loperamide Adverse Eventsmentioning

confidence: 78%

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

Section: Loperamide Adverse Eventsmentioning

confidence: 99%

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Loperamide: A Readily Available but Dangerous Opioid Substitute

White

2019

The Journal of Clinical Pharma

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Clinical characteristics of over‐the‐counter (OTC) drug abusers in psychiatric practice in Japan: Comparison of single and multiple OTC product abusers

Tanibuchi,

Omiya,

Usami

et al. 2024

Neuropsychopharm Rep

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ObjectiveTo examine the clinical characteristics of over‐the‐counter (OTC) drug abusers in psychiatric practice in Japan.MethodWe examined the attributes, ICD‐10 subcategory, and comorbid mental disorders of patients who mainly abuse OTC products and compared the clinical characteristics of single product and multiple products abusers, using the database of the “2022 Nationwide Mental Hospital Survey of Drug‐related Disorders.”ResultsAmong the 2468 subjects included in this survey, 273 (11.1%) used OTC products as main drugs. Of these, 209 (78.3%) and 58 (21.7%) were classified into the single product group and the multiple products group, respectively. Six were excluded for unknown ingredients. By comparing these groups, we found that many of the multiple products group consisted of young women who were recently treated for drug problems. Many subjects in the group also had a short treatment period. No differences were observed between the groups regarding the ICD‐10 F1 subcategory, but many subjects in the multiple products group fulfilled the criteria of F6 “disorders of adult personality and behavior.”ConclusionOTC products are easily accessible drugs of abuse for young women in Japan. The results of this study indicate the necessity to reconsider the educational approach for preventing drug abuse, which has focused on illicit drugs. The study also indicates that some OTC products, which contain ingredients banned overseas due to their harmful effects, are still sold in Japan and that abusers for those products exist. Measures by the government are considered urgently needed.

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