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Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs

Objective: To investigate the occurrence of adverse effects of antiepileptic drugs (AEDs) in pediatric epileptic patients on mono- or polytherapy. Method: We evaluated eighty consecutive patients that met the following inclusion criteria: aged ≤18 years; diagnosed with epilepsy for at least one year...

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Autores principales: Kopciuch, Dorota, Kus, Krzysztof, Fliciński, Jędrzej, Steinborn, Barbara, Winczewska-Wiktor, Anna, Paczkowska, Anna, Zaprutko, Tomasz, Ratajczak, Piotr, Nowakowska, Elżbieta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9028571/
https://www.ncbi.nlm.nih.gov/pubmed/35457375
http://dx.doi.org/10.3390/ijerph19084509
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author Kopciuch, Dorota
Kus, Krzysztof
Fliciński, Jędrzej
Steinborn, Barbara
Winczewska-Wiktor, Anna
Paczkowska, Anna
Zaprutko, Tomasz
Ratajczak, Piotr
Nowakowska, Elżbieta
author_facet Kopciuch, Dorota
Kus, Krzysztof
Fliciński, Jędrzej
Steinborn, Barbara
Winczewska-Wiktor, Anna
Paczkowska, Anna
Zaprutko, Tomasz
Ratajczak, Piotr
Nowakowska, Elżbieta
author_sort Kopciuch, Dorota
collection PubMed
description Objective: To investigate the occurrence of adverse effects of antiepileptic drugs (AEDs) in pediatric epileptic patients on mono- or polytherapy. Method: We evaluated eighty consecutive patients that met the following inclusion criteria: aged ≤18 years; diagnosed with epilepsy for at least one year; a stable dose of AED for at least three months; verbal consent to participation in the study. Patients were asked if they had experienced any adverse drug reaction (ADR) related to the AED. Afterward, regardless of the answer, they were interviewed based on a detailed semi-structured questionnaire about the presence of ADRs associated with the AED. The data were analyzed regarding the use of monotherapy or polytherapy. Results: Ninety-seven percent of the patients reported having experienced ADRs related to AEDs. The greatest number of seizures affected the group of patients treated with monotherapy (both at baseline and at followup), but the greatest number of ADRs were observed among patients treated with polytherapy. In patients on monotherapy, the most frequent ADRs reported at baseline included fatigue and somnolence, and among patients with polytherapy, it was fatigue and hair loss. Conclusion: Children on polytherapy were significantly more likely to develop ADRs compared to those on monotherapy, but a statistically significant improvement in seizure frequency was also observed in the group of patients on polytherapy. Pharmacovigilance is very important in children with AEDs, so that ADRs can be identified early and managed appropriately.
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spelling pubmed-90285712022-04-23 Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs Kopciuch, Dorota Kus, Krzysztof Fliciński, Jędrzej Steinborn, Barbara Winczewska-Wiktor, Anna Paczkowska, Anna Zaprutko, Tomasz Ratajczak, Piotr Nowakowska, Elżbieta Int J Environ Res Public Health Article Objective: To investigate the occurrence of adverse effects of antiepileptic drugs (AEDs) in pediatric epileptic patients on mono- or polytherapy. Method: We evaluated eighty consecutive patients that met the following inclusion criteria: aged ≤18 years; diagnosed with epilepsy for at least one year; a stable dose of AED for at least three months; verbal consent to participation in the study. Patients were asked if they had experienced any adverse drug reaction (ADR) related to the AED. Afterward, regardless of the answer, they were interviewed based on a detailed semi-structured questionnaire about the presence of ADRs associated with the AED. The data were analyzed regarding the use of monotherapy or polytherapy. Results: Ninety-seven percent of the patients reported having experienced ADRs related to AEDs. The greatest number of seizures affected the group of patients treated with monotherapy (both at baseline and at followup), but the greatest number of ADRs were observed among patients treated with polytherapy. In patients on monotherapy, the most frequent ADRs reported at baseline included fatigue and somnolence, and among patients with polytherapy, it was fatigue and hair loss. Conclusion: Children on polytherapy were significantly more likely to develop ADRs compared to those on monotherapy, but a statistically significant improvement in seizure frequency was also observed in the group of patients on polytherapy. Pharmacovigilance is very important in children with AEDs, so that ADRs can be identified early and managed appropriately. MDPI 2022-04-08 /pmc/articles/PMC9028571/ /pubmed/35457375 http://dx.doi.org/10.3390/ijerph19084509 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Kopciuch, Dorota
Kus, Krzysztof
Fliciński, Jędrzej
Steinborn, Barbara
Winczewska-Wiktor, Anna
Paczkowska, Anna
Zaprutko, Tomasz
Ratajczak, Piotr
Nowakowska, Elżbieta
Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
title Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
title_full Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
title_fullStr Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
title_full_unstemmed Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
title_short Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
title_sort pharmacovigilance in pediatric patients with epilepsy using antiepileptic drugs
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9028571/
https://www.ncbi.nlm.nih.gov/pubmed/35457375
http://dx.doi.org/10.3390/ijerph19084509
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