Cognitive Development Considerations for Long-term Safety Exposures in Children

Pipan, Mary; Wang, Paul P.; Penna, Rebecca

doi:10.1002/9781118312087.ch30

Cited by 2 publications

(1 citation statement)

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“…Sedation, somnolence, and lethargy ADRs are associated with negative effects including learning disabilities in children. [20][21][22] Additional important ADRs included weight gain, fatigue, orthostatic hypotension, and tachycardia, which are all likely to decrease the tolerance of and adherence to these medications in the pediatric patient population. Given the limitation of unbalanced treatment experience between adult and pediatric patients, the long-term consequences of this difference in ADRs in pediatric patients are Unknown.…”

Section: Original Articlesmentioning

confidence: 99%

A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration

Liu

Schuette

Burckart

et al. 2019

The Journal of Pediatrics

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Objective To examine the differences in the adverse drug reaction (ADR) profile of antipsychotic and antidepressant agents between pediatric and adult patients in studies submitted to the Food and Drug Administration (FDA) during the drug development process.Study design Clinical trials in adult and pediatric patients were conducted by sponsors as part of the drug development programs for antipsychotic and antidepressant agents, and ADR information was collected as part of those trials and submitted to the FDA. Data collection was conducted by reviewing publicly available FDA-authored reviews and FDA-approved product labels for 10 drugs with an antipsychotic or an antidepressant indication from 2007 to 2017.Results There were 308 drug and ADR combinations for the 10 drugs and drug combinations with 113 (36.7%) having a significantly different incidence in pediatric patients compared with adults. Sixty-eight (60.2%) of these ADRs had a significantly higher incidence in pediatric patients than in adults. Sedation was higher in 6 of the 10 drugs and drug combinations with risk differences ranging from 9.6 to 36.6%.Conclusions This analysis indicates that there were significant differences between the pediatric and adult safety profiles of antipsychotic and antidepressant drugs. Sedation was the major ADR associated with the use of atypical antipsychotic drugs in pediatric patients. Clinicians caring for children should consider the ADR profile when prescribing antipsychotics and antidepressants in pediatric patients. (J Pediatr 2019;208:236-42).

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Section: Original Articlesmentioning

confidence: 99%