RT info:eu-repo/semantics/article
T1 Clozapine-induced myocarditis in children and adolescents: a pharmacovigilance study using VigiBase and a systematic literature review
A1 Cuevas Castresana, Carlos de las
A1 Sanz Álvarez, Emilio José
A1 Ruan, Can-Jun
A1 Arrojo Romero, Manuel
A1 Schoretsanitis, Georgios
A1 León, José de
A2 Medicina InternaDermatología y Psiquiatría
A2 Adherencia Terapéutica
K1 Adolescent
K1 clozapine/adverse effects
K1 clozapine/metabolism
K1 clozapine/toxicity
K1 mortality/drug effects
K1 myocarditis/chemically induced
K1 myocarditis/etiology
AB Introduction: Clozapine-induced myocarditis in children (age ≤18 yo) was studied from a PubMed search (18 July 2022) (9 cases) and from the World Health Organization's pharmacovigilance database, called Vigibase, of adverse drug reaction (ADR) reports (72 non-duplicated cases). VigiBase uses a logarithmic measure of disproportionality called the information component (IC). A logistic regression model of presence/absence (40/32) of seriousness in VigiBase was developed.Areas covered: VigiBase provided a significant myocarditis IC = 4.2 with an IC025 = 3.8; only 4 clozapine-induced myocarditis cases were expected, while 72 were observed. The PubMed search identified 9 cases, while VigiBase identified 72 cases (of which 67 did not overlap with published cases). These 76 combined cases included 35 doubtful (most with missing information on the day of diagnosis), 19 possible and 22 probable, according to the ADR scale. After adjusting for confounders, quetiapine increased the risk of seriousness with an odds ratio (OR) of 17.6 (95% confidence interval CI, 1.56 to 198.6), while Australian origin decreased it with an OR = 0.13 (CI, 0.04 to 0.47).Expert opinion: These 41 cases of at least possible clozapine-induced myocarditis indicated that this ADR can definitively occur in children, particularly in the first 30 days of up-titration. Children's and adult cases appeared similar.
YR 2022
FD 2022
LK http://riull.ull.es/xmlui/handle/915/39588
UL http://riull.ull.es/xmlui/handle/915/39588
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 26-mar-2025