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Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database

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Abstract

Introduction

Studies that evaluate the safety of non-prescription drugs in children remain scarce.

Objectives

The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children.

Methods

We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test.

Results

We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 ± 5.3 vs. 8.4 ± 5.7 years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with prescription drugs (21.0%) than with non-prescription drugs (14.2%, p = 0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-prescription than with prescription drugs (p = 0.0006 and p < 0.0001, respectively). The frequency of “serious” ADRs was higher with prescription drugs than with non-prescription drugs (40.9 vs. 34.2%, p = 0.007). The non-prescription drugs most frequently implicated with serious ADRs were ibuprofen (n = 37; 4.2%), tuberculosis vaccine (n = 23; 2.6%), aspirin (n = 20, 2.3%), and paracetamol (n = 17; 1.9%). ADRs from prescription drugs involved asparaginase (n = 27; 3.1%), immunoglobulins (n = 25; 2.9%), and amoxicillin (n = 23; 2.4%).

Conclusions

Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen.

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Author information

Authors and Affiliations

  1. Service de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d’Informations sur les Médicaments, Pharmacopôle Midi-Pyrénées, Toulouse University Hospital, UMR1027 INSERM Pharmacoepidemiology Unit, Faculty of Medicine, University of Toulouse, Toulouse, France

    Geneviève Durrieu, Mathieu Maupiler, Vanessa Rousseau, Leila Chebane, François Montastruc, Emmanuelle Bondon-Guitton & Jean-Louis Montastruc

  2. Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, 37 Allées Jules Guesde, 31000, Toulouse, France

    Geneviève Durrieu

Authors
  1. Geneviève Durrieu
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  2. Mathieu Maupiler
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  3. Vanessa Rousseau
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  4. Leila Chebane
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  5. François Montastruc
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  6. Emmanuelle Bondon-Guitton
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  7. Jean-Louis Montastruc
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Contributions

GD conceptualized and supervised the study, drafted the initial manuscript, and reviewed and revised the manuscript. MM carried out the initial data analysis. VR conducted the final analysis and reviewed the manuscript. LC was responsible for acquisition of data. FM reviewed the manuscript. EBG contributed to the concept and the design of the study and reviewed the manuscript. JLM reviewed and revised the manuscript. All authors approved the final manuscript for submission and agreed to be accountable for all aspects of the work.

Corresponding author

Correspondence to Geneviève Durrieu.

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Funding source

No funding was secured for this study.

Conflict of interest

GD, MM, VR, LC, FM, EBG, JLM) have no conflicts of interest relevant to this article.

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Durrieu, G., Maupiler, M., Rousseau, V. et al. Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database. Pediatr Drugs 20, 81–87 (2018). https://doi.org/10.1007/s40272-017-0255-z

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