ArticlePaediatric drugs2018
Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.
Article in Paediatric drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 10 citations in OpenAlex.
- Contributions of Pharmacovigilance to the Understanding of Risks Associated with Ibuprofen: Descriptive and Disproportionality Analysis Using FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Assessment of Paracetamol Usage Practices and Perceptions among Caregivers for Children Post-COVID-19 in Saudi Arabia: A Cross-Sectional Analysis.Healthcare (Basel, Switzerland) · 2024Article
- The Use of Non-Prescribed Medicines in Infants from Birth to Six Months in Rural Areas of Polokwane Municipality-Limpopo Province, South Africa.Children (Basel, Switzerland) · 2024Article
- Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding.Pharmacy (Basel, Switzerland) · 2020Article
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionStudies that evaluate the safety of non-prescription drugs in children remain scarce.
objectivesThe aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children.
methodsWe 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.
resultsWe 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%).
conclusionsNon-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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