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 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.

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Publication Details

Journal
European Psychiatry
Published
2025-01-10
DOI
https://doi.org/10.1192/j.eurpsy.2024.1816
Citations
32
Primary Topic
Schizophrenia research and treatment
Type
article
Field-Weighted Citation Impact
47.08
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article

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

Selene Veerman, Jimmi Nielsen, Emílio J. Sanz, Marieke M. Beex‐Oosterhuis et al.
32 citations
European Psychiatry
Schizophrenia research and treatment
47.08
article

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

Selene Veerman, Jimmi Nielsen, Emílio J. Sanz, Marieke M. Beex‐Oosterhuis, Dolores Keating, Robert A. Bittner, Konstantinos Ν. Fountoulakis, Carlos De las Cuevas, Andreja Čelofiga, Christopher Rohde, Daniel Guinart, Jan Bogers, Alina Wilkowska, Jurjen J. Luykx, Dan Cohen, Mishal Qubad, Espen Molden, Hélène Verdoux, Alexis Lepetit, Olalla Maroñas, Manuel Arrojo, Marc D. Binder, Edoardo Spina, Ivona Šimunović Filipčić, Judit Lazáry, Domenico De Berardis, Heidi T. Taipale, Christian Bachmann, Jari Tiihonen, Miloslav Kopeček, Bjørn Hylsebeck Ebdrup, Elias M. Wagner, Marina Šagud, Brian N. O'Donoghue, Peter F.J. Schulte, Heli Tuppurainen, John Lally, I. Sommer, Alkomiet Hasan, Flavian Ștefan Rădulescu, Pierre OSWALD
article en
32 citations

Abstract

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.

European PsychiatryVol. 68(1)
University College Dublin (IE), University of Messina (IT), Goethe University Frankfurt (DE), University of Copenhagen (DK), Centre National de la Recherche Scientifique (FR), Northwell Health (US), Université Libre de Bruxelles (BE), University Medical Center Groningen (NL), University of Helsinki (FI), University Hospital Centre Zagreb (HR), University of Antwerp (BE), Université de Bordeaux (FR), Inserm (FR), Universidad de La Laguna (ES), Carol Davila University of Medicine and Pharmacy (RO), University of Groningen (NL), University of Eastern Finland (FI), University of Augsburg (DE), University of Zagreb (HR), King's College London (GB), University of Oslo (NO), Universität Ulm (DE), Universidade de Santiago de Compostela (ES), Aarhus University (DK), Charles University (CZ), Aristotle University of Thessaloniki (GR), Maastricht University Medical Centre (NL), Hospital Universitario de Canarias (ES), Mental Health Services (DK), Instituto de Salud Carlos III (ES), Niuvanniemi Hospital (FI), Stockholm County Council (SE), Glostrup Hospital (DK), Aarhus University Hospital (DK), Copenhagen University Hospital (DK), Karolinska Institutet (SE), Maastricht University (NL), Noordwest Ziekenhuisgroep (NL), GGZ Noord-Holland-Noord (NL), Centro de Investigación Biomédica en Red de Salud Mental (ES), Albert Schweitzer Ziekenhuis (NL), Complejo Hospitalario Universitario de Santiago (ES), Hospices Civils de Lyon (FR), Centre Hospitalier Universitaire Brugmann (BE), National Institute of Menthal Health, Neurology and Neurosurgery - Nyírő Gyula Hospital (HU), Bordeaux Population Health (FR), Donald & Barbara Zucker School of Medicine at Hofstra/Northwell (US), Amsterdam Neuroscience (NL), Centre for Biomedical Network Research on Rare Diseases (ES), Leefmilieu Brussel (BE), St. Vincent's University Hospital (IE), German Center for Infection Research (DE), Diakonhjemmet Hospital (NO), Fundación Pública Galega de Medicina Xenómica (ES), GGZ Rivierduinen (NL), German Centre for Cardiovascular Research (DE), University Clinical Centre Maribor (SI), Hospital Del Mar (ES), University Hospital Frankfurt (DE), Parc de Salut (ES), St John of God Hospital (AU), GGZ inGeest (NL), Instituto de Investigación Sanitaria de Santiago (ES), Public Health Service of Amsterdam (NL), Amsterdam University Medical Centers (NL), Groupe Lépine (France) (FR), Institut des Sciences Cognitives (FR), University Hospital Ulm (DE), Servicio Gallego de Salud (ES), German Center for Diabetes Research (DE), Technische Hochschule Ulm (DE), Groupe de Recherche en Écologie Arctique (FR), National Institute of Mental Health (CZ), Saint John of God Hospital, University of Osijek (HR), Gdańsk Medical University (PL), KU Leuven (BE)
Openalex Percentile: Top 0%
Schizophrenia research and treatment
47.08
DOIOpen Access PDFOpenAlex
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