Paediatric Postmarketing Pharmacovigilance Using Prescription-Event Monitoring
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ORIGINAL RESEARCH ARTICLE
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Paediatric Postmarketing Pharmacovigilance Using Prescription-Event Monitoring Comparison of the Adverse Event Profiles of Lamotrigine Prescribed to Children and Adults in England Beate Aurich-Barrera,1,2 Lynda Wilton,1,2 David Brown1,2 and Saad Shakir1,2 1 Drug Safety Research Unit, Southampton, UK 2 Division of Pharmacy Practice, School of Pharmacy and Biomedical Sciences, Portsmouth University, Portsmouth, UK
Abstract
Background: Using postmarketing pharmacovigilance data collected shortly after market authorization of lamotrigine in the UK, a study was conducted to compare the adverse event (AE) profiles of children and adults taking lamotrigine, using modified signal detection methods. Methods: Data from the lamotrigine Prescription Event Monitoring (PEM) study, an observational cohort study, were stratified by age and examined using summary statistics for adverse drug reactions (ADRs), reasons for stopping treatment, deaths and follow-up information. Incidence densities of AEs in children (0–17 years) and adults (‡18 years) in the first month of treatment were compared with months 2–6 to examine whether the AE rates were different in these two periods. AE rates in children were compared with those in adults (proportional reporting ratio [PRR] and incidence rate ratios), to compare the AE profiles between these age groups. Results: The cohort included 2457 children and 7379 adults. Differences in the AE profiles between children and adults were observed. Rash (PRR 1.2) and Stevens-Johnson syndrome (PRR 4.5) were more commonly reported in children, and confusion more frequently in adults (PRR 6.3). In children, 33% of ADRs were reported to the Regulatory Authority compared with 44% in adults. A higher proportion of children stopped treatment due to lack of effectiveness (45% vs 38%). No deaths were attributed to lamotrigine. Conclusions: This study demonstrated that signal detection methods can be used to detect quantitative and qualitative differences in the AE profiles between the first children and adults taking a newly licensed drug.
Aurich-Barrera et al.
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Background In the early 1960s the thalidomide disaster led to an increasing awareness of the issues surrounding drug safety. Many of these concerns affected children, who have often been excluded from drug safety and efficacy studies due to concerns about ethics, practicability and financial reasons. Summaries of product characteristics (SPCs) frequently include only limited paediatric drug safety information. To address the issue of off-label and unlicensed prescribing in children, European regulations were issued to oblige pharmaceutical companies to submit a paediatric investigation plan for all new compounds, indications and formulations from January 2007 onwards.[1-3] Paediatric pharmacovigilance activities will have to be included in the benefit-risk management plan and other pharmacovigilance activities. Paediatric clinical trials of many new compounds could
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