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

. 2025 Jan 10 ; 68 (1) : e17. [epub] 20250110

Jazyk angličtina Země Velká Británie, Anglie Médium electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid39788917

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.

3rd Department of Psychiatry Division of Neurosciences School of Medicine Faculty of Health Sciences Aristotle University of Thessaloniki Thessaloniki Greece

Amsterdam Neuroscience Research Institutes Amsterdam The Netherlands

Antwerp Health Law and Ethics Chair University of Antwerp Antwerp Belgium

Center for Drug Sciences Faculty of Pharmacy University of Medicine and Pharmacy Carol Davila Bucharest Romania

Center for Neuropsychiatric Schizophrenia Research Mental Health Center Glostrup Copenhagen University Hospital Mental Health Services CPH Copenhagen Denmark

Center for Psychopharmacology Diakonhjemmet Hospital Oslo Norway

Centre for Biomedical Network Research on Rare Diseases Instituto de Salud Carlos 3 Madrid Spain

Department for Psychiatry and Psychological Medicine University Hospital Center Zagreb Zagreb Croatia

Department of Affective Disorders Aarhus University Hospital Psychiatry Aarhus Denmark

Department of Child and Adolescent Psychiatry Ulm University Ulm Germany

Department of Clinical and Experimental Medicine University of Messina Messina Italy

Department of Clinical Medicine Aarhus University Aarhus Denmark

Department of Clinical Medicine Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Department of Clinical Neuroscience Karolinska Institutet and Center for Psychiatry Research Stockholm City Council Stockholm Sweden

Department of Forensic Psychiatry University of Eastern Finland Niuvanniemi Hospital Kuopio Finland

Department of Hospital Pharmacy Albert Schweitzer Hospital Dordrecht The Netherlands

Department of Internal Medicine Dermatology and Psychiatry School of Medicine University of La Laguna Canary Islands Spain

Department of Neuroscience and Department of Psychiatry University Medical Center Groningen University of Groningen Groningen The Netherlands

Department of Neurosciences Centre for Clinical Psychiatry Katholieke Universiteit Leuven Leuven Belgium

Department of Physical Medicine and Pharmacology School of Medicine Universidad de La Laguna Canary Islands Spain

Department of Psychiatry 3rd Faculty of Medicine Charles University Prague Czech Republic

Department of Psychiatry Amsterdam UMC Amsterdam The Netherlands

Department of Psychiatry and Neuropsychology School for Mental Health and Neuroscience Maastricht University Medical Center Maastricht The Netherlands

Department of Psychiatry and Psychological Medicine University Hospital Centre Zagreb Zagreb Croatia

Department of Psychiatry Complejo Hospitalario Universitario de Santiago Santiago de Compostela Spain

Department of Psychiatry Hôpital Universitaire de Bruxelles Bruxelles Belgium

Department of Psychiatry Medical University of Gdańsk Gdańsk Poland

Department of Psychiatry Psychotherapy and Psychosomatics Medical Faculty University of Augsburg Augsburg Germany

Department of Psychiatry School of Medicine and Medical Science University College Dublin Dublin Ireland

Department of Psychiatry School of Medicine University of Zagreb Zagreb Croatia

Department of Psychiatry St Vincent's Hospital Fairview Dublin Ireland

Department of Psychiatry St Vincent's University Hospital Dublin Ireland

Department of Psychiatry University College Dublin Dublin Ireland

Department of Psychiatry University Medical Centre Maribor Maribor Slovenia

Department of Psychosis Studies Institute of Psychiatry Psychology and Neuroscience King's College London London UK

Dutch Clozapine Collaboration Group Alkmaar The Netherlands

DZPG Partner Site Munich Augsburg Germany

Esdege Reigersdaal Heerhugowaard The Netherlands

Evidence based Psychiatry and Psychotherapy Faculty of Medicine University of Augsburg Augsburg Germany

Faculty of Dental Medicine and Health Josip Juraj Strossmayer University of Osijek Osijek Croatia

French Clozapine Task Force University of Bordeaux Inserm Bordeaux Population Health Research Center Bordeaux France

French Clozapine Task Force; ACPPA Group Francheville France

Galician Public Foundation of Genomic Medicine Santiago de Compostela Spain

Genomic Medicine Group CIMUS University of Santiago de Compostela Santiago de Compostela Spain

GGZ inGeest Mental Health Care Amsterdam The Netherlands

Goethe University Frankfurt University Hospital Department of Psychiatry Psychosomatic Medicine and Psychotherapy Frankfurt am Main Germany

Hospices Civils de Lyon Hôpital des Charpennes Villeurbanne France

Hospital Universitario de Canarias Tenerife Spain

Institut de Salut Mental Hospital del Mar Barcelona Spain

Institut des Sciences Cognitives Marc Jeannerod CNRS Bron France

Leuven Brain Institute Katholieke Universiteit Leuven Leuven Belgium

Mental Health Centre Glostrup Copenhagen University Hospital Copenhagen Denmark

Mental Health Organization Rivierduinen Leiden The Netherlands

Mental Health Services Noord Holland Noord Alkmaar The Netherlands

Mental Health Services Noord Holland Noord Schagen The Netherlands

National Institute of Mental Health Klecany Czech Republic

Neuroscience Center University of Helsinki Helsinki Finland

NHS Department of Mental Health G Mazzini Hospital Teramo Italy

Nyírő Gyula National Institute of Psychiatry and Addictions Budapest Hungary

Pharmacogenomics and Drug Discovery Santiago de Compostela Spain

Programa Recerca en Salut Mental Hospital del Mar Research Institute CIBERSAM Barcelona Spain

Saint John of God Hospital Stillorgan Co Dublin Dublin Ireland

School of Pharmacy University of Eastern Finland Kuopio Finland

Section for Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Oslo Norway

The Donald and Barbara Zucker School of Medicine Northwell Health New York NY USA

University Psychiatric Center Katholieke Universiteit Leuven Kortenberg Belgium

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