Evidence map›Paper›PMID 30679050›Full record

ArticleThe Journal of pediatrics2019

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

Xiaomei I Liu, Paul Schuette, Gilbert J Burckart, Dionna J Green, Julie La, Janelle M Burnham, Natella Rakhmanina, Adelaide Robb, Shiew Mei Huang, John N van den Anker

Open access · greenAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Evaluation of off-label medication use and drug safety in a pediatric intensive care unit.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
    Article
  15. Review
  16. Review
  17. Article
  18. Observational
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Xiaomei I LiuChildren's National Medical Center, Washington, DC.
Paul SchuetteOffice of Biostatistics, United States Food and Drug Administration, Silver Spring, MD.
Gilbert J BurckartOffice of Clinical Pharmacology, United States Food and Drug Administration, Silver Spring, MD. Electronic address: Gilbert.Burckart@fda.hhs.gov.
Dionna J GreenOffice of Pediatric Therapeutics, United States Food and Drug Administration, Silver Spring, MD.
Julie LaLoma Linda School of Pharmacy, Loma Linda, CA.
Janelle M BurnhamOffice of Clinical Pharmacology, United States Food and Drug Administration, Silver Spring, MD.
Natella RakhmaninaChildren's National Medical Center, Washington, DC.
Adelaide RobbChildren's National Medical Center, Washington, DC.
Shiew Mei HuangOffice of Clinical Pharmacology, United States Food and Drug Administration, Silver Spring, MD.
John N van den AnkerChildren's National Medical Center, Washington, DC.
United States Food and Drug Administration · USChildren's National · USLoma Linda University · US

Funding

Postdoctoral training in Pediatric Clinical PharmacologyT32HD087969 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2016 to 2020
$998k
Intramural FDA HHS FD999999NICHD NIH HHS T32 HD087969
6 · The paper itself

Abstract

objectiveTo 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

designClinical 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.

resultsThere 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%.

conclusionsThis 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.

Indexed as

Patient SafetyAdolescentAdultAntidepressive AgentsAntipsychotic AgentsChildClinical Trials as TopicDrug-Related Side Effects and Adverse ReactionsHumansIncidencePediatricsRiskUnited StatesUnited States Food and Drug AdministrationAntidepressive AgentsAntipsychotic Agentsadverse drug effectsantidepressantantipsychoticdrug developmentpediatricregulatoryUS FDA

Identifiers

PMID30679050
PMCPMC7171692
OpenAlexW2911849339

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.