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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2025-01-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Hélène Verdoux |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-f5989871f57648738e9d067a246e93db |
| institution | Kabale University |
| issn | 0924-9338 1778-3585 |
| language | English |
| publishDate | 2025-01-01 |
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| series | European Psychiatry |
| spelling | doaj-art-f5989871f57648738e9d067a246e93db2025-01-27T10:02:32ZengCambridge University PressEuropean Psychiatry0924-93381778-35852025-01-016810.1192/j.eurpsy.2024.1816The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task ForceHélène Verdoux0https://orcid.org/0000-0003-2948-3782Robert A. Bittner1https://orcid.org/0000-0003-2021-0358Alkomiet Hasan2Mishal Qubad3https://orcid.org/0000-0002-9291-5739Elias Wagner4https://orcid.org/0000-0002-7147-6167Alexis Lepetit5https://orcid.org/0009-0001-1490-871XManuel Arrojo-Romero6https://orcid.org/0000-0002-5609-7134Christian Bachmann7Marieke Beex-Oosterhuis8https://orcid.org/0000-0002-3070-3626Jan Bogers9https://orcid.org/0000-0001-7273-0027Andreja Celofiga10https://orcid.org/0000-0003-3979-9545Dan Cohen11https://orcid.org/0000-0003-1542-4255Domenico de Berardis12https://orcid.org/0000-0003-4415-5058Marc de Hert13https://orcid.org/0000-0003-4255-5920Carlos de Las Cuevas14https://orcid.org/0000-0001-5742-905XBjørn H. Ebdrup15https://orcid.org/0000-0002-2590-5055Konstantinos N. Fountoulakis16https://orcid.org/0000-0001-5503-0811Daniel Guinart17https://orcid.org/0000-0001-5078-6716Dolores Keating18https://orcid.org/0000-0001-7507-2680Miloslav Kopeček19https://orcid.org/0000-0002-0576-6887John Lally20https://orcid.org/0000-0003-3038-0625Judit Lazáry21https://orcid.org/0000-0003-0059-8893Jurjen J. Luykx22Olalla Maronas Amigo23https://orcid.org/0000-0001-6952-3377Espen Molden24https://orcid.org/0000-0001-6190-2751Jimmi Nielsen25Brian O’Donoghue26https://orcid.org/0000-0001-6240-6952Pierre Oswald27https://orcid.org/0009-0009-2712-3717Flavian S. Radulescu28https://orcid.org/0000-0002-1885-5459Christopher Rohde29https://orcid.org/0000-0001-9458-506XMarina Sagud30https://orcid.org/0000-0001-9620-2181Emilio J. Sanz31https://orcid.org/0000-0001-6788-4435Ivona Šimunović Filipčić32https://orcid.org/0000-0002-3265-0046Iris E. Sommer33https://orcid.org/0000-0002-2682-5313Heidi Taipale34https://orcid.org/0000-0002-3281-934XJari Tiihonen35https://orcid.org/0000-0002-0400-6798Heli Tuppurainen36https://orcid.org/0009-0007-9059-4605Selene Veerman37https://orcid.org/0000-0002-7604-6529Alina Wilkowska38https://orcid.org/0000-0001-7258-6811Edoardo Spina39https://orcid.org/0000-0002-2509-7449Peter Schulte40https://orcid.org/0000-0003-4931-3393French Clozapine Task Force, University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, FranceGoethe University Frankfurt, University Hospital, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Frankfurt am Main, GermanyDepartment of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Augsburg, Germany DZPG (German Center for Mental Health), Partner Site, Munich/Augsburg, GermanyGoethe University Frankfurt, University Hospital, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Frankfurt am Main, GermanyDepartment of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Augsburg, Germany Evidence-based Psychiatry and Psychotherapy, Faculty of Medicine, University of Augsburg, Augsburg, GermanyFrench Clozapine Task Force; ACPPA Group, Francheville, France Hospices Civils de Lyon, Hôpital des Charpennes, Villeurbanne, France Institut des Sciences Cognitives Marc Jeannerod, CNRS, Bron, FranceDepartment of Psychiatry, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, SpainDepartment of Child and Adolescent Psychiatry, Ulm University, Ulm, GermanyDepartment of Hospital Pharmacy, Albert Schweitzer Hospital, Dordrecht, The NetherlandsMental Health Organization Rivierduinen, Leiden, The NetherlandsDepartment of Psychiatry, University Medical Centre Maribor, Maribor, SloveniaDutch Clozapine Collaboration Group, Alkmaar, The Netherlands Esdege-Reigersdaal, Heerhugowaard, The NetherlandsNHS, Department of Mental Health, G. Mazzini Hospital, Teramo, ItalyUniversity Psychiatric Center Katholieke Universiteit Leuven, Kortenberg, Belgium Department of Neurosciences, Centre for Clinical Psychiatry, Katholieke Universiteit Leuven, Leuven, Belgium Leuven Brain Institute, Katholieke Universiteit Leuven, Leuven, Belgium Antwerp Health Law and Ethics Chair, University of Antwerp, Antwerp, BelgiumDepartment of Internal Medicine, Dermatology and Psychiatry, School of Medicine, University of La Laguna, Canary Islands, SpainCenter for Neuropsychiatric Schizophrenia Research (CNSR), Mental Health Center, Glostrup, Copenhagen University Hospital – Mental Health Services CPH, Copenhagen, Denmark Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark3rd Department of Psychiatry, Division of Neurosciences, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, GreeceInstitut de Salut Mental, Hospital del Mar, Barcelona, Spain Programa Recerca en Salut Mental, Hospital del Mar Research Institute, CIBERSAM, Barcelona, Spain The Donald and Barbara Zucker School of Medicine, Northwell Health, New York, NY, USASaint John of God Hospital, Stillorgan, Co. Dublin, Dublin, IrelandNational Institute of Mental Health, Klecany, Czech Republic Department of Psychiatry, Third Faculty of Medicine, Charles University, Prague, Czech RepublicDepartment of Psychiatry, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland Department of Psychiatry, St Vincent’s Hospital Fairview, Dublin, Ireland Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King’s College London, London, UKNyírő Gyula National Institute of Psychiatry and Addictions, Budapest, HungaryDepartment of Psychiatry, Amsterdam UMC, Amsterdam, The Netherlands GGZ inGeest Mental Health Care, Amsterdam, The Netherlands Amsterdam Neuroscience (Mood, Anxiety, Psychosis, Stress & Sleep program) and Amsterdam Public Health (Mental Health program) Research Institutes, Amsterdam, The Netherlands Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience Maastricht University Medical Center, Maastricht, The NetherlandsPharmacogenomics and Drug Discovery (GenDeM), Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain Genomic Medicine Group, CIMUS, University of Santiago de Compostela, Santiago de Compostela, Spain Centre for Biomedical Network Research on Rare Diseases (CIBERER), Instituto de Salud Carlos III, Madrid, Spain Galician Public Foundation of Genomic Medicine (FPGMX), Galician Healthcare Service (SERGAS), Santiago de Compostela, SpainSection for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, NorwayMental Health Centre Glostrup, Copenhagen University Hospital, Copenhagen, DenmarkDepartment of Psychiatry, University College Dublin, Dublin, Ireland Department of Psychiatry, St Vincent’s University Hospital, Dublin, IrelandDepartment of Psychiatry, Hôpital Universitaire de Bruxelles, Bruxelles, BelgiumCenter for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, RomaniaDepartment of Affective Disorders, Aarhus University, Hospital - Psychiatry, Aarhus, Denmark Department of Clinical Medicine, Aarhus University, Aarhus, DenmarkDepartment of Psychiatry, School of Medicine, University of Zagreb, Zagreb, Croatia Department for Psychiatry and Psychological Medicine, University Hospital Center Zagreb, Zagreb, CroatiaDepartment of Physical Medicine and Pharmacology, School of Medicine, Universidad de La Laguna, Canary Islands, Spain Hospital Universitario de Canarias, Tenerife, SpainDepartment of Psychiatry and Psychological Medicine, University Hospital Centre Zagreb, Zagreb, Croatia Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, CroatiaDepartment of Neuroscience, and Department of Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland Department of Clinical Neuroscience, Karolinska Institutet, and Center for Psychiatry Research, Stockholm City Council, Stockholm, Sweden School of Pharmacy, University of Eastern Finland, Kuopio, FinlandDepartment of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland Department of Clinical Neuroscience, Karolinska Institutet, and Center for Psychiatry Research, Stockholm City Council, Stockholm, Sweden Neuroscience Center, University of Helsinki, Helsinki, FinlandDepartment of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, FinlandMental Health Services Noord-Holland-Noord, Schagen, The Netherlands Dutch Clozapine Collaboration Group, Alkmaar, The NetherlandsDepartment of Psychiatry, Medical University of Gdańsk, Gdańsk, PolandDepartment of Clinical and Experimental Medicine, University of Messina, Messina, ItalyDutch Clozapine Collaboration Group, Alkmaar, The Netherlands Mental Health Services Noord-Holland-Noord, Alkmaar, The NetherlandsThe 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.https://www.cambridge.org/core/product/identifier/S0924933824018169/type/journal_articleblood monitoringclozapineregulationtreatment-resistant schizophrenia |
| spellingShingle | 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 The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force European Psychiatry blood monitoring clozapine regulation treatment-resistant schizophrenia |
| title | The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force |
| title_full | The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force |
| title_fullStr | The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force |
| title_full_unstemmed | The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force |
| title_short | The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force |
| title_sort | time has come for revising the rules of clozapine blood monitoring in europe a joint expert statement from the european clozapine task force |
| topic | blood monitoring clozapine regulation treatment-resistant schizophrenia |
| url | https://www.cambridge.org/core/product/identifier/S0924933824018169/type/journal_article |
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