Evidence map›Paper›PMID 30484072›Full record

ArticlePaediatric drugs2019

Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review.

Kazeem A Oshikoya, Gerold T Wharton, Debbie Avant, Sara L Van Driest, Norman E Fenn, Allison Lardieri, Edwin Doe, Beena G Sood, Carol Taketomo, Phuong Lieu and 2 more

Open access · bronzeAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Paediatric drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

7 citing papers in PubMed, 22 citations in OpenAlex.

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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

12 authors at 7 institutions in 1 country.

Kazeem A OshikoyaVanderbilt University School of Medicine, Nashville, TN, USA.
Gerold T WhartonOffice of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Building 32, Room 5158, Silver Spring, MD, 20993, USA.
Debbie AvantOffice of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Building 32, Room 5158, Silver Spring, MD, 20993, USA.
Sara L Van DriestVanderbilt University School of Medicine, Nashville, TN, USA.
Norman E FennChildren's National Health System, Washington, DC, USA.
Allison LardieriUniversity of Maryland Children's Hospital, Baltimore, MD, USA.
Edwin DoeINOVA Children's Hospital, Falls Church, VA, USA.
Beena G SoodChildren's Hospital of Michigan, Detroit, MI, USA.
Carol TaketomoChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Phuong LieuChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Lilly YenChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Ann W McMahonOffice of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Building 32, Room 5158, Silver Spring, MD, 20993, USA. Ann.mcmahon@fda.hhs.gov.
Children's Hospital of Los Angeles · USUnited States Food and Drug Administration · USVanderbilt University · USChildren's Hospital of Michigan · USChildren's National · USInova Children's Hospital · USUniversity of Maryland, Baltimore · US

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
CLINICAL PHARMACOLOGY TRAINING PROGRAMT32GM007569 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Bjorn C Knollmann · 1985 to 2026
$12.4M
Intramural FDA HHS FD999999NCATS NIH HHS UL1 TR000445NIGMS NIH HHS T32 GM007569
6 · The paper itself

Abstract

objectivesHalf of prescription drugs commonly given to children lack product labeling on pediatric safety, efficacy, and dosing. Two drugs most widely used off-label in pediatrics are azithromycin and fentanyl. We sought to determine the risk of serious adverse events (SAEs) when oral azithromycin or intravenous/intramuscular fentanyl are used off-label compared to on-label in pediatric intensive care units (ICUs). STUDY

designSix pediatric hospitals participated in a retrospective chart review of patients administered oral azithromycin (n = 241) or intravenous/intramuscular fentanyl (n = 367) between January 5, 2013 and December 26, 2014. Outcomes were SAEs by drug and labeling status: off-label compared to on-label by Food and Drug Administration (FDA)-approved age and/or indication. Statistical analysis was performed using logistic regression to estimate odds ratios (ORs) and Cox regression to estimate hazard ratios (HRs).

resultsTwenty-one (9%) children receiving azithromycin experienced SAEs. Off-label use of azithromycin was not associated with a higher risk of SAE (OR 0.87, 95% CI 0.27-2.71, p = 0.81). Ninety-five (26%) children receiving fentanyl experienced SAEs. Fentanyl off-label use by both age and indication was not associated with a higher risk of overall SAEs compared to on-label use (OR 1.99, 95% CI 0.94-4.19, p = 0.07). However, the risk of the SAE respiratory depression was significantly greater when fentanyl was used off-label by both age and indication (OR 5.05, 95% CI 1.08-23.56, p = 0.044). Results based on HRs were similar.

conclusionsAzithromycin off-label use in pediatric ICUs does not appear to be associated with an increased risk of SAEs. Off-label use of fentanyl appears to be more frequently associated with respiratory depression when used off-label by both age and indication in pediatric ICUs. Prospective studies should be undertaken to assess the safety and efficacy of fentanyl in the pediatric population so that data can be added to the FDA labeling.

Indexed as

Intensive Care Units, PediatricOff-Label UseAdministration, IntravenousAdministration, OralAdolescentAnalgesics, OpioidAnti-Bacterial AgentsAzithromycinChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsFemaleFentanylHospitals, PediatricHumansInfantAnalgesics, OpioidAnti-Bacterial AgentsAzithromycinFentanylPrescription Drugs

Identifiers

PMID30484072
PMCPMC6387682
OpenAlexW2902579454

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.