The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force

The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force

The European Clozapine Task Force is a group of psychiatrists and pharmacologists practicing in 18 countries under European Medicines Agency (EMA) regulation, who are deeply concerned about the underuse of clozapine in European countries. Although clozapine is the most effective antipsychotic for pe...

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Main Authors: Hélène Verdoux, Robert A. Bittner, Alkomiet Hasan, Mishal Qubad, Elias Wagner, Alexis Lepetit, Manuel Arrojo-Romero, Christian Bachmann, Marieke Beex-Oosterhuis, Jan Bogers, Andreja Celofiga, Dan Cohen, Domenico de Berardis, Marc de Hert, Carlos de Las Cuevas, Bjørn H. Ebdrup, Konstantinos N. Fountoulakis, Daniel Guinart, Dolores Keating, Miloslav Kopeček, John Lally, Judit Lazáry, Jurjen J. Luykx, Olalla Maronas Amigo, Espen Molden, Jimmi Nielsen, Brian O’Donoghue, Pierre Oswald, Flavian S. Radulescu, Christopher Rohde, Marina Sagud, Emilio J. Sanz, Ivona Šimunović Filipčić, Iris E. Sommer, Heidi Taipale, Jari Tiihonen, Heli Tuppurainen, Selene Veerman, Alina Wilkowska, Edoardo Spina, Peter Schulte
Format: Article
Language:English
Published: Cambridge University Press 2025-01-01
Series:European Psychiatry
Subjects:
blood monitoring
clozapine
regulation
treatment-resistant schizophrenia
Online Access:https://www.cambridge.org/core/product/identifier/S0924933824018169/type/journal_article
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Summary:The European Clozapine Task Force is a group of psychiatrists and pharmacologists practicing in 18 countries under European Medicines Agency (EMA) regulation, who are deeply concerned about the underuse of clozapine in European countries. Although clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia, a large proportion of them do not have access to this treatment. Concerns about clozapine-induced agranulocytosis and stringent blood monitoring rules are major barriers to clozapine prescribing and use. There is a growing body of evidence that the incidence of clozapine-induced agranulocytosis is very low after the first year of treatment. Maintaining lifelong monthly blood monitoring after this period contributes to unjustified discontinuation of clozapine. We leverage recent and replicated evidence on the long-term safety of clozapine to call for the revision and updating of the EMA’s blood monitoring rules, thus aiming to overcome this major barrier to clozapine prescribing and use. We believe the time has come for relaxing the rules without increasing the risks for people using clozapine in Europe.
ISSN:0924-9338
1778-3585

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