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@article{43edfd95def042db93f9600dc17f32cf,
title = "Beyond the Purple Drank. Study of promethazine abuse according to the European Medicines Agency (EMA) Adverse Drug Reactions (ADR) reports.",
abstract = "Background: Promethazine is a medicinal product, available on its own or in combination with other ingredients including dextromethorphan, paracetamol, and/or expectorants. Anecdotal reports have however indicated that promethazine may have a misuse potential, especially in adolescents. Objective: We aimed at studying how this phenomenon has been reported to the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs) database. Methods: After a formal request to the EMA, the promethazine-specific dataset has been studied performing a descriptive analysis of the misuse/abuse/dependence related-ADR reports. The study was approved by the University of Hertfordshire (LMS/PGR/UH/03234). Results: The analysis of promethazine data showed increasing levels of misuse/abuse/ dependence issues over time (2003-2019). Out of a total number of 1,543 ADRs{\textquoteright} cases, the abuse/misuse/dependence-related cases reported were 557, with {\textquoteleft}drug abuse{\textquoteright} (300/557: 53.8%) and {\textquoteleft}intentional product misuse{\textquoteright} (117/557: 21.0%). being the most represented ADRs. A high number of fatalities were described (310/557: 55.6%), mostly recorded as {\textquoteleft}drug toxicity/drug abuse{\textquoteright} cases, with opiates/opioids having been the most commonly reported concomitant drugs used. Conclusion: Anecdotal promethazine misuse/abuse reports have been confirmed by EMA data. Promethazine misuse/abuse appears to be an alarming issue, being associated with drug-related fatalities. Thus, healthcare professionals should be warned about a possible misuse of promethazine and be vigilant, as in some countries medicinal products containing promethazine can be purchased over the counter. Since promethazine is often available in association with opioids, its abuse may be considered a public health issue, with huge implications for clinical practice.",
keywords = "promethazine, promethazine misuse, drug abuse, purple drank, sizzurp, codeine/promethazine, Adverse Drug Reactions, ADR, pharmacovigilance",
author = "Stefania Chiappini and Fabrizio Schifano and Corkery, {John Martin} and Amira Guirguis",
note = "Submitted 30 April; revisions submitted 17 July 2020; accepted 8 August 2020; first published 10 January 2021.",
year = "2021",
month = jan,
day = "10",
doi = "10.1177/0269881120959615",
language = "English",
journal = "Journal of Psychopharmacology",
issn = "0269-8811",
publisher = "SAGE Publications Ltd",

}

RIS

TY - JOUR

T1 - Beyond the Purple Drank. Study of promethazine abuse according to the European Medicines Agency (EMA) Adverse Drug Reactions (ADR) reports.

AU - Chiappini, Stefania

AU - Schifano, Fabrizio

AU - Corkery, John Martin

AU - Guirguis, Amira

N1 - Submitted 30 April; revisions submitted 17 July 2020; accepted 8 August 2020; first published 10 January 2021.

PY - 2021/1/10

Y1 - 2021/1/10

N2 - Background: Promethazine is a medicinal product, available on its own or in combination with other ingredients including dextromethorphan, paracetamol, and/or expectorants. Anecdotal reports have however indicated that promethazine may have a misuse potential, especially in adolescents. Objective: We aimed at studying how this phenomenon has been reported to the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs) database. Methods: After a formal request to the EMA, the promethazine-specific dataset has been studied performing a descriptive analysis of the misuse/abuse/dependence related-ADR reports. The study was approved by the University of Hertfordshire (LMS/PGR/UH/03234). Results: The analysis of promethazine data showed increasing levels of misuse/abuse/ dependence issues over time (2003-2019). Out of a total number of 1,543 ADRs’ cases, the abuse/misuse/dependence-related cases reported were 557, with ‘drug abuse’ (300/557: 53.8%) and ‘intentional product misuse’ (117/557: 21.0%). being the most represented ADRs. A high number of fatalities were described (310/557: 55.6%), mostly recorded as ‘drug toxicity/drug abuse’ cases, with opiates/opioids having been the most commonly reported concomitant drugs used. Conclusion: Anecdotal promethazine misuse/abuse reports have been confirmed by EMA data. Promethazine misuse/abuse appears to be an alarming issue, being associated with drug-related fatalities. Thus, healthcare professionals should be warned about a possible misuse of promethazine and be vigilant, as in some countries medicinal products containing promethazine can be purchased over the counter. Since promethazine is often available in association with opioids, its abuse may be considered a public health issue, with huge implications for clinical practice.

AB - Background: Promethazine is a medicinal product, available on its own or in combination with other ingredients including dextromethorphan, paracetamol, and/or expectorants. Anecdotal reports have however indicated that promethazine may have a misuse potential, especially in adolescents. Objective: We aimed at studying how this phenomenon has been reported to the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs) database. Methods: After a formal request to the EMA, the promethazine-specific dataset has been studied performing a descriptive analysis of the misuse/abuse/dependence related-ADR reports. The study was approved by the University of Hertfordshire (LMS/PGR/UH/03234). Results: The analysis of promethazine data showed increasing levels of misuse/abuse/ dependence issues over time (2003-2019). Out of a total number of 1,543 ADRs’ cases, the abuse/misuse/dependence-related cases reported were 557, with ‘drug abuse’ (300/557: 53.8%) and ‘intentional product misuse’ (117/557: 21.0%). being the most represented ADRs. A high number of fatalities were described (310/557: 55.6%), mostly recorded as ‘drug toxicity/drug abuse’ cases, with opiates/opioids having been the most commonly reported concomitant drugs used. Conclusion: Anecdotal promethazine misuse/abuse reports have been confirmed by EMA data. Promethazine misuse/abuse appears to be an alarming issue, being associated with drug-related fatalities. Thus, healthcare professionals should be warned about a possible misuse of promethazine and be vigilant, as in some countries medicinal products containing promethazine can be purchased over the counter. Since promethazine is often available in association with opioids, its abuse may be considered a public health issue, with huge implications for clinical practice.

KW - promethazine

KW - promethazine misuse

KW - drug abuse

KW - purple drank

KW - sizzurp

KW - codeine/promethazine

KW - Adverse Drug Reactions

KW - ADR

KW - pharmacovigilance

U2 - 10.1177/0269881120959615

DO - 10.1177/0269881120959615

M3 - Article

JO - Journal of Psychopharmacology

JF - Journal of Psychopharmacology

SN - 0269-8811

M1 - JOP-2020-4294.R1

ER -