RT info:eu-repo/semantics/article
T1 Revealing the reporting disparity: vigiBase highlights underreporting of clozapine in other Western European countries compared to the UK.
A1 Cuevas Castresana, Carlos de las
A1 Sanz Álvarez, Emilio José
A1 Gross, Jason A.
A1 Verdoux, Hélène
A1 Corell, Christoph U.
A1 Lally, John
A1 Filippis, Renato de
A1 Schulte, Peter F. J.
A1 Molden, Espen
A1 Arrojo Romero, Manuel
A1 Bostrom, Adrián D.
A1 Schoretsanitis, Georgios
A1 Fernández Egea, Emilio
A1 León, José de
K1 Clozapine, adverse effects
K1 Clozapine, administration and dosage
K1 Clozapine, therapeutic use
K1 Drug labeling
K1 Europe
K1 Schizophrenia
AB Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs). Objective: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization's pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality. Methods: VigiBase reports from clozapine's introduction to December 31, 2022, were studied for ADRs and the top 10 causes of fatal outcomes. The UK was compared with 11 other top reporting Western countries (Germany, Denmark, France, Finland, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland). Nine countries (except Ireland and Switzerland) were compared after controlling for population and clozapine prescriptions.
SN 1573-2509
YR 2023
FD 2023
LK http://riull.ull.es/xmlui/handle/915/39634
UL http://riull.ull.es/xmlui/handle/915/39634
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 27-mar-2025