Evidence map›Paper›PMID 38002866›Full record

ArticleChildren (Basel, Switzerland)2023

Analysis of Adverse Drug Reactions in Pediatric Patients with Epilepsy: An Intensive Pharmacovigilance Study.

Ernestina Hernández García, Lizbeth Naranjo, Luz Adriana Pichardo-Macías, María Josefa Bernad Bernad, Lucila Isabel Castro-Pastrana, Matilde Ruíz García, Tanya Alejandra García Bernal, Jessica Lizbeth Mendoza Solís, David Calderón Guzmán, Luisa Díaz-García and 2 more

Open access · goldAbstract read
In one paragraph

Article in Children (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 13% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Cognition in pediatric patients with diagnosis of epilepsyRevista medica del Instituto Mexicano del Seguro Social · 2024
    Article
  3. 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

12 authors at 5 institutions in 1 country.

Ernestina Hernández GarcíaLaboratorio de Farmacología, Subdirección de Medicina Experimental, Instituto Nacional de Pediatría, Ciudad de Mexico 04530, Mexico.ORCID 0000-0002-0613-8196
Lizbeth NaranjoDepartamento de Matemáticas, Facultad de Ciencias, Universidad Nacional Autónoma de Mexico, Ciudad de Mexico 04510, Mexico.ORCID 0000-0002-9078-6363
Luz Adriana Pichardo-MacíasDepartamento de Fisiología, Instituto Politécnico Nacional, Escuela Nacional de Ciencias Biológicas, Ciudad de Mexico 07738, Mexico.ORCID 0000-0002-7412-8459
María Josefa Bernad BernadDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de Mexico, Ciudad de Mexico 04510, Mexico.
Lucila Isabel Castro-PastranaDepartamento de Ciencias Químico Biológicas, Universidad de las Américas Puebla, Puebla 72810, Mexico.ORCID 0000-0001-6724-6441
Matilde Ruíz GarcíaServicio de Neurología, Dirección Médica, Instituto Nacional de Pediatría, Ciudad de Mexico 04530, Mexico.ORCID 0000-0001-5542-8387
Tanya Alejandra García BernalFarmacia Intrahospitalaria, Hospital General Dr. Manuel Gea González, Ciudad de Mexico 14080, Mexico.
Jessica Lizbeth Mendoza SolísFacultad de Medicina, Universidad Nacional Autónoma de Mexico, Ciudad de Mexico 04360, Mexico.
David Calderón GuzmánLaboratorio de Neurociencias, Subdirección de Medicina Experimental, Instituto Nacional de Pediatría, Ciudad de Mexico 04530, Mexico.ORCID 0000-0002-7373-9389
Luisa Díaz-GarcíaDepartamento de Metodología de la Investigación, Subdirección de Investigación Clínica, Instituto Nacional de Pediatría, Ciudad de Mexico 04530, Mexico.ORCID 0000-0001-6757-3688
Julieta Griselda Mendoza-TorreblancaLaboratorio de Neurociencias, Subdirección de Medicina Experimental, Instituto Nacional de Pediatría, Ciudad de Mexico 04530, Mexico.ORCID 0000-0003-0702-5318
Juan Luis Chávez PachecoLaboratorio de Farmacología, Subdirección de Medicina Experimental, Instituto Nacional de Pediatría, Ciudad de Mexico 04530, Mexico.ORCID 0000-0001-6919-4497
Instituto Nacional de Pediatria · MXUniversidad Nacional Autónoma de México · MXHospital General Dr. Manuel Gea Gonzalez · MXInstituto Politécnico Nacional · MXUniversidad de las Américas Puebla · MX

Funding

Instituto Nacional de Pediatria 090/2012
6 · The paper itself

Abstract

Epilepsy is a chronic neurological disease characterized by the presence of spontaneous seizures, with a higher incidence in the pediatric population. Anti-seizure medication (ASM) may produce adverse drug reactions (ADRs) with an elevated frequency and a high severity. Thus, the objective of the present study was to analyze, through intensive pharmacovigilance over 112 months, the ADRs produced by valproic acid (VPA), oxcarbazepine (OXC), phenytoin (PHT), and levetiracetam (LEV), among others, administered to monotherapy or polytherapy for Mexican hospitalized pediatric epilepsy patients. A total of 1034 patients were interviewed; 315 met the inclusion criteria, 211 patients presented ADRs, and 104 did not. A total of 548 ASM-ADRs were identified, and VPA, LEV, and PHT were the main culprit drugs. The most frequent ADRs were drowsiness, irritability, and thrombocytopenia, and the main systems affected were hematologic, nervous, and dermatologic. LEV and OXC caused more nonsevere ADRs, and PHT caused more severe ADRs. The risk analysis showed an association between belonging to the younger groups and polytherapy with ADR presence and between polytherapy and malnutrition with severe ADRs. In addition, most of the severe ADRs were preventable, and most of the nonsevere ADRs were nonpreventable.

Indexed as

adverse drug reactionsanti-seizure medicationepilepsygeneralized estimating equationslevetiracetamlogistic regressionphenytoinrisk factorsvalproic acid

Identifiers

PMID38002866
PMCPMC10670375
OpenAlexW4388141567

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.