Pediatric drug surveillance and the food and drug administration's adverse event reporting system: an overview of reports, 2003–2007

Johann-Liang, Rosemary; Wyeth, Jo; Chen, Min; Cope, Judith U.

doi:10.1002/pds.1679

Cited by 46 publications

(17 citation statements)

References 5 publications

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“…The number of AE reported in children has been growing since 2008. A 2009 study reported a flat trend from 2003 to 2007 in AEs reported to the FDA for children (mean 7248 reports/yr) . However, we found that the number of AEs increased from 12,100 in 2008 to 21,227 reports in 2011 (data not shown).…”

Section: Discussioncontrasting

confidence: 59%

“…Like us, these investigators also found ADHD drugs and antiepileptics to be the most common categories of medications among AE reports in children. Another group using the FAERS database in 2003–2007 reported that ADHD medications, antiepileptics and antipsychotics were the top drug classes associated with AEs in children aged 2–10 years and in adolescents 11–16 years of age . Additionally, the ADHD medication atomoxetine has been found to be among the most commonly reported drugs associated with AE in children aged 0–17 years, based on an analysis from the WHO global individual case safety report database (Vigibase) .…”

Section: Discussionmentioning

confidence: 99%

“…Analysis of the FAERS data has been used primarily to describe adverse drug events in adults. The few published studies of the FAERS data related to children have focused on drug classes rather than individual medications . To the best of our knowledge, there has been no recent analysis of the most commonly suspected medications and the associated AEs in different pediatric age groups.…”

mentioning

confidence: 99%

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Drugs Associated with Adverse Events in Children and Adolescents

Lee

Pickard

et al. 2014

Pharmacotherapy

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Section: Discussioncontrasting

confidence: 59%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Drugs Associated with Adverse Events in Children and Adolescents

Lee

Pickard

et al. 2014

Pharmacotherapy

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“…Finally, an overview of ADRs reported to the FDA’s Adverse Event Reporting System revealed that the number of pediatric reports to the Adverse Event Reporting System over the past 5 years has remained steady (Figure 1), while reports for adults have increased fivefold over the same time period. The authors concluded that improvement in the passive surveillance system is needed from a pediatric perspective, and recommended that investments be made in active surveillance systems to better capture risk information in children [14]. …”

Section: Adr Reporting In Children: General Considerations and Challengesmentioning

confidence: 99%

Identifying Genomic and Developmental Causes of Adverse Drug Reactions in Children

Becker

Leeder

2010

Pharmacogenomics

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Adverse drug reactions are a concern for all clinicians who utilize medications to treat adults and children; however, the frequency of adult and pediatric adverse drug reactions is likely to be under-reported. In this age of genomics and personalized medicine, identifying genetic variation that results in differences in drug biotransformation and response has contributed to significant advances in the utilization of several commonly used medications in adults. In order to better understand the variability of drug response in children however, we must not only consider differences in genotype, but also variation in gene expression during growth and development, namely ontogeny. In this article, recommendations for systematically approaching pharmacogenomic studies in children are discussed, and several examples of studies that investigate the genomic and developmental contribution to adverse drug reactions in children are reviewed.

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“…The result is a potential delay in the authorisation of antibiotics for children and a consequent increase in off-label prescribing [5]. Moreover, given the paucity of information of new antibiotics in children, data on drug safety and tolerability are often extrapolated from adult studies, with the consequent risks of underestimating toxicity, inadequate dosages and clinical failures [6].…”

Section: Introductionmentioning

confidence: 99%

New antibiotics for paediatric use: A review of a decade of regulatory trials submitted to the European Medicines Agency from 2000—Why aren’t we doing better?

Garazzino¹,

Lutsar²,

Bertaina³

et al. 2013

International Journal of Antimicrobial Agents

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New initiatives have been introduced in Europe and the USA to encourage more rapid development of antibiotics. The need to ensure these new antibiotics can be safely used in children, and especially neonates, is important owing to high antimicrobial resistance in these patient groups. This review aims to determine what lessons can be learnt from the recent regulatory processes to speed up access to new medicines for children, focusing on antibiotics licensed for adults by the EMA since 2000. For the 11 newly approved antibiotics, 31 clinical trials enrolling children in Europe were identified. However, many of these trials included both adults and children but did not provide a subset analysis for paediatrics, limiting the relevance of their findings. Some studies have been prematurely terminated and others are apparently active but are still not yet recruiting patients. Among paediatric-specific studies, 18 evaluate safety and efficacy of new compounds, 4 are pharmacokinetic studies, but only 2 focus on neonates. Nearly all studies with an agreed Paediatric Investigation Plan have just started or are not yet recruiting. For most antibiotics, despite adult phase 3 studies being completed, with specific concerns for particular drugs already noted, it will take another 3-5 years before adequate prescribing information becomes available for paediatricians. Evidence from this review suggests that we could do better. Lessons should be learnt from paediatric antiretroviral development, with neonatal and paediatric pharmacokinetic, clinical trial and pharmacovigilance drug development programmes being run directly in parallel with adult studies-not a decade behind.

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Pediatric drug surveillance and the food and drug administration's adverse event reporting system: an overview of reports, 2003–2007

Cited by 46 publications

References 5 publications

Drugs Associated with Adverse Events in Children and Adolescents

Drugs Associated with Adverse Events in Children and Adolescents

Identifying Genomic and Developmental Causes of Adverse Drug Reactions in Children

New antibiotics for paediatric use: A review of a decade of regulatory trials submitted to the European Medicines Agency from 2000—Why aren’t we doing better?

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