Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

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

H. Verdoux, RA. Bittner, A. Hasan, M. Qubad, E. Wagner, A. Lepetit, M. Arrojo-Romero, C. Bachmann, M. Beex-Oosterhuis, J. Bogers, A. Celofiga, D. Cohen, D. de Berardis, M. de Hert, C. de Las Cuevas, BH. Ebdrup, KN. Fountoulakis, D. Guinart, D....

. 2025 ; 68 (1) : e17. [pub] 20250110

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc25010287

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

ACPPA Group Francheville France

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

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

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25010287
003      
CZ-PrNML
005      
20250429134614.0
007      
ta
008      
250415s2025 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1192/j.eurpsy.2024.1816 $2 doi
035    __
$a (PubMed)39788917
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Verdoux, Hélène $u French Clozapine Task Force, University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France $1 https://orcid.org/0000000329483782
245    14
$a The time has come for revising the rules of clozapine blood monitoring in Europe. A joint expert statement from the European Clozapine Task Force / $c H. Verdoux, RA. Bittner, A. Hasan, M. Qubad, E. Wagner, A. Lepetit, M. Arrojo-Romero, C. Bachmann, M. Beex-Oosterhuis, J. Bogers, A. Celofiga, D. Cohen, D. de Berardis, M. de Hert, C. de Las Cuevas, BH. Ebdrup, KN. Fountoulakis, D. Guinart, D. Keating, M. Kopeček, J. Lally, J. Lazáry, JJ. Luykx, O. Maronas Amigo, E. Molden, J. Nielsen, B. O'Donoghue, P. Oswald, FS. Radulescu, C. Rohde, M. Sagud, EJ. Sanz, I. Šimunović Filipčić, IE. Sommer, H. Taipale, J. Tiihonen, H. Tuppurainen, S. Veerman, A. Wilkowska, E. Spina, P. Schulte
520    9_
$a 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.
650    12
$a klozapin $x terapeutické užití $x škodlivé účinky $x krev $7 D003024
650    _2
$a lidé $7 D006801
650    12
$a antipsychotika $x terapeutické užití $x škodlivé účinky $7 D014150
650    12
$a agranulocytóza $x chemicky indukované $7 D000380
650    12
$a monitorování léčiv $x metody $x normy $7 D016903
650    _2
$a poradní výbory $7 D026683
650    _2
$a refrakterní schizofrenie $x farmakoterapie $7 D000090663
651    _2
$a Evropa $7 D005060
655    _2
$a časopisecké články $7 D016428
700    1_
$a Bittner, Robert A $u Goethe University Frankfurt, University Hospital, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Frankfurt am Main, Germany $1 https://orcid.org/0000000320210358
700    1_
$a Hasan, Alkomiet $u Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Augsburg, Germany $u DZPG (German Center for Mental Health), Partner Site, Munich/Augsburg, Germany
700    1_
$a Qubad, Mishal $u Goethe University Frankfurt, University Hospital, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Frankfurt am Main, Germany $1 https://orcid.org/0000000292915739
700    1_
$a Wagner, Elias $u Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Augsburg, Germany $u Evidence-based Psychiatry and Psychotherapy, Faculty of Medicine, University of Augsburg, Augsburg, Germany $1 https://orcid.org/0000000271476167
700    1_
$a Lepetit, Alexis $u French Clozapine Task Force; ACPPA Group, Francheville, France $u Hospices Civils de Lyon, Hôpital des Charpennes, Villeurbanne, France $u Institut des Sciences Cognitives Marc Jeannerod, CNRS, Bron, France $1 https://orcid.org/000900011490871X
700    1_
$a Arrojo-Romero, Manuel $u Department of Psychiatry, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain $1 https://orcid.org/0000000256097134
700    1_
$a Bachmann, Christian $u Department of Child and Adolescent Psychiatry, Ulm University, Ulm, Germany
700    1_
$a Beex-Oosterhuis, Marieke $u Department of Hospital Pharmacy, Albert Schweitzer Hospital, Dordrecht, The Netherlands $1 https://orcid.org/0000000230703626
700    1_
$a Bogers, Jan $u Mental Health Organization Rivierduinen, Leiden, The Netherlands $1 https://orcid.org/0000000172730027
700    1_
$a Celofiga, Andreja $u Department of Psychiatry, University Medical Centre Maribor, Maribor, Slovenia $1 https://orcid.org/0000000339799545
700    1_
$a Cohen, Dan $u Dutch Clozapine Collaboration Group, Alkmaar, The Netherlands $u Esdege-Reigersdaal, Heerhugowaard, The Netherlands $1 https://orcid.org/0000000315424255
700    1_
$a de Berardis, Domenico $u NHS, Department of Mental Health, G. Mazzini Hospital, Teramo, Italy $1 https://orcid.org/0000000344155058
700    1_
$a de Hert, Marc $u University Psychiatric Center Katholieke Universiteit Leuven, Kortenberg, Belgium $u Department of Neurosciences, Centre for Clinical Psychiatry, Katholieke Universiteit Leuven, Leuven, Belgium $u Leuven Brain Institute, Katholieke Universiteit Leuven, Leuven, Belgium $u Antwerp Health Law and Ethics Chair, University of Antwerp, Antwerp, Belgium $1 https://orcid.org/0000000342555920
700    1_
$a de Las Cuevas, Carlos $u Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine, University of La Laguna, Canary Islands, Spain $1 https://orcid.org/000000015742905X
700    1_
$a Ebdrup, Bjørn H $u Center for Neuropsychiatric Schizophrenia Research (CNSR), Mental Health Center, Glostrup, Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, Denmark $u Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark $1 https://orcid.org/0000000225905055
700    1_
$a Fountoulakis, Konstantinos N $u 3rd Department of Psychiatry, Division of Neurosciences, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece $1 https://orcid.org/0000000155030811
700    1_
$a Guinart, Daniel $u Institut de Salut Mental, Hospital del Mar, Barcelona, Spain $u Programa Recerca en Salut Mental, Hospital del Mar Research Institute, CIBERSAM, Barcelona, Spain $u The Donald and Barbara Zucker School of Medicine, Northwell Health, New York, NY, USA $1 https://orcid.org/0000000150786716
700    1_
$a Keating, Dolores $u Saint John of God Hospital, Stillorgan, Co. Dublin, Dublin, Ireland $1 https://orcid.org/0000000175072680
700    1_
$a Kopeček, Miloslav $u National Institute of Mental Health, Klecany, Czech Republic $u Department of Psychiatry, Third Faculty of Medicine, Charles University, Prague, Czech Republic $1 https://orcid.org/0000000205766887 $7 js20070525003
700    1_
$a Lally, John $u Department of Psychiatry, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland $u Department of Psychiatry, St Vincent's Hospital Fairview, Dublin, Ireland $u Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK $1 https://orcid.org/0000000330380625
700    1_
$a Lazáry, Judit $u Nyírő Gyula National Institute of Psychiatry and Addictions, Budapest, Hungary $1 https://orcid.org/0000000300598893
700    1_
$a Luykx, Jurjen J $u Department of Psychiatry, Amsterdam UMC, Amsterdam, The Netherlands $u GGZ inGeest Mental Health Care, Amsterdam, The Netherlands $u Amsterdam Neuroscience (Mood, Anxiety, Psychosis, Stress & Sleep program) and Amsterdam Public Health (Mental Health program) Research Institutes, Amsterdam, The Netherlands $u Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience Maastricht University Medical Center, Maastricht, The Netherlands
700    1_
$a Maronas Amigo, Olalla $u Pharmacogenomics and Drug Discovery (GenDeM), Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain $u Genomic Medicine Group, CIMUS, University of Santiago de Compostela, Santiago de Compostela, Spain $u Centre for Biomedical Network Research on Rare Diseases (CIBERER), Instituto de Salud Carlos III, Madrid, Spain $u Galician Public Foundation of Genomic Medicine (FPGMX), Galician Healthcare Service (SERGAS), Santiago de Compostela, Spain $1 https://orcid.org/0000000169523377
700    1_
$a Molden, Espen $u Section for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway $u Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway $1 https://orcid.org/0000000161902751
700    1_
$a Nielsen, Jimmi $u Mental Health Centre Glostrup, Copenhagen University Hospital, Copenhagen, Denmark
700    1_
$a O'Donoghue, Brian $u Department of Psychiatry, University College Dublin, Dublin, Ireland $u Department of Psychiatry, St Vincent's University Hospital, Dublin, Ireland $1 https://orcid.org/0000000162406952
700    1_
$a Oswald, Pierre $u Department of Psychiatry, Hôpital Universitaire de Bruxelles, Bruxelles, Belgium $1 https://orcid.org/0009000927123717
700    1_
$a Radulescu, Flavian S $u Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania $1 https://orcid.org/0000000218855459
700    1_
$a Rohde, Christopher $u Department of Affective Disorders, Aarhus University, Hospital - Psychiatry, Aarhus, Denmark $u Department of Clinical Medicine, Aarhus University, Aarhus, Denmark $1 https://orcid.org/000000019458506X
700    1_
$a Sagud, Marina $u Department of Psychiatry, School of Medicine, University of Zagreb, Zagreb, Croatia $u Department for Psychiatry and Psychological Medicine, University Hospital Center Zagreb, Zagreb, Croatia $1 https://orcid.org/0000000196202181
700    1_
$a Sanz, Emilio J $u Department of Physical Medicine and Pharmacology, School of Medicine, Universidad de La Laguna, Canary Islands, Spain $u Hospital Universitario de Canarias, Tenerife, Spain $1 https://orcid.org/0000000167884435
700    1_
$a Šimunović Filipčić, Ivona $u Department of Psychiatry and Psychological Medicine, University Hospital Centre Zagreb, Zagreb, Croatia $u Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia $1 https://orcid.org/0000000232650046
700    1_
$a Sommer, Iris E $u Department of Neuroscience, and Department of Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands $1 https://orcid.org/0000000226825313
700    1_
$a Taipale, Heidi $u Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland $u Department of Clinical Neuroscience, Karolinska Institutet, and Center for Psychiatry Research, Stockholm City Council, Stockholm, Sweden $u School of Pharmacy, University of Eastern Finland, Kuopio, Finland $1 https://orcid.org/000000023281934X
700    1_
$a Tiihonen, Jari $u Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland $u Department of Clinical Neuroscience, Karolinska Institutet, and Center for Psychiatry Research, Stockholm City Council, Stockholm, Sweden $u Neuroscience Center, University of Helsinki, Helsinki, Finland $1 https://orcid.org/0000000204006798
700    1_
$a Tuppurainen, Heli $u Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland $1 https://orcid.org/0009000790594605
700    1_
$a Veerman, Selene $u Mental Health Services Noord-Holland-Noord, Schagen, The Netherlands $u Dutch Clozapine Collaboration Group, Alkmaar, The Netherlands $1 https://orcid.org/0000000276046529
700    1_
$a Wilkowska, Alina $u Department of Psychiatry, Medical University of Gdańsk, Gdańsk, Poland $1 https://orcid.org/0000000172586811
700    1_
$a Spina, Edoardo $u Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy $1 https://orcid.org/0000000225097449
700    1_
$a Schulte, Peter $u Dutch Clozapine Collaboration Group, Alkmaar, The Netherlands $u Mental Health Services Noord-Holland-Noord, Alkmaar, The Netherlands $1 https://orcid.org/0000000349313393
773    0_
$w MED00001658 $t European psychiatry $x 1778-3585 $g Roč. 68, č. 1 (2025), s. e17
856    41
$u https://pubmed.ncbi.nlm.nih.gov/39788917 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250415 $b ABA008
991    __
$a 20250429134609 $b ABA008
999    __
$a ok $b bmc $g 2311569 $s 1247368
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 68 $c 1 $d e17 $e 20250110 $i 1778-3585 $m European psychiatry $n Eur Psychiatry $x MED00001658
LZP    __
$a Pubmed-20250415

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...