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Escaping the Long Shadow Cast by Agranulocytosis: Reflections on Clozapine Pharmacovigilance Focused on the United Kingdom.
de Leon, Jose; Arrojo-Romero, Manuel; Verdoux, Hélène; Ruan, Can-Jun; Schoretsanitis, Georgios; Rohde, Christopher; Cohen, Dan; Schulte, Peter F J; Kim, Se Hyun; Cotes, Robert O; Leung, Jonathan G; Otsuka, Yuji; Kirilochev, Oleg O; Baptista, Trino; Grover, Sandeep; Every-Palmer, Susanna; Clark, Scott R; McGrane, Ian R; Motuca, Mariano; Olmos, Ismael; Wilkowska, Alina; Sagud, Marina; Anil Yagcioglu, A Elif; Ristic, Dragana Ignjatovic; Lazary, Judit; Sanz, Emilio J; De Las Cuevas, Carlos.
Afiliación
  • Arrojo-Romero M; Department of Psychiatry, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
  • Verdoux H; Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, F-33000 Bordeaux, France.
  • Kim SH; Department of Psychiatry, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Cotes RO; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.
  • Leung JG; Department of Pharmacy, Mayo Clinic, Rochester, MN.
  • Otsuka Y; Department of Psychiatry, Asahi General Hospital, Chiba, Japan.
  • Kirilochev OO; Department of Clinical Pharmacology, Astrakhan State Medical University, Astrakhan, Russian Federation.
  • Grover S; Department of Psychiatry, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
  • Clark SR; University of Adelaide, Discipline of Psychiatry, Adelaide, South Australia, Australia.
  • McGrane IR; Department of Pharmacy Practice, University of Montana, Missoula, MT.
  • Motuca M; Instituto Vilapriño, Center for Studies, Assistance and Research in Neurosciences, Mendoza, Argentina.
  • Olmos I; Clinical Pharmacology Unit and Pharmacy Department, Vilardebó Hospital, Administración de Servicios de Salud, Montevideo, Uruguay.
  • Wilkowska A; Department of Psychiatry, Medical University of Gdansk, Gdansk, Poland.
  • Anil Yagcioglu AE; Department of Psychiatry, Hacettepe University Faculty of Medicine, Ankara, Turkey.
  • Ristic DI; University of Kragujevac, Faculty of Medical Sciences, Department of Psychiatry, Kragujevac, Serbia.
  • Lazary J; National Institute of Mental Health, Neurology and Neurosurgery, Budapest, Hungary.
  • De Las Cuevas C; Department of Internal Medicine, Dermatology and Psychiatry and Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary Islands, Spain.
J Clin Psychopharmacol ; 43(3): 239-245, 2023.
Article en En | MEDLINE | ID: mdl-37068034
PURPOSE/BACKGROUND: A recent article in this journal presented a US perspective regarding the modernization of clozapine prescription and proposed an escape from the long shadow cast by agranulocytosis. METHODS: Here, an international group of collaborators discusses a point of view complementary to the US view by focusing on worldwide outcomes of clozapine usage that may be uneven in terms of frequency of clozapine adverse drug reactions. FINDINGS/RESULTS: Studies from the Scandinavian national registries (Finland and Denmark) did not find increased mortality in clozapine patients or any clear evidence of the alleged toxicity of clozapine. Data on clozapine-associated fatal outcomes were obtained from 2 recently published pharmacovigilance studies and from the UK pharmacovigilance database. A pharmacovigilance study focused on physician reports to assess worldwide lethality of drugs from 2010 to 2019 found 968 clozapine-associated fatal outcomes in the United Kingdom. Moreover, the United Kingdom accounted for 55% (968 of 1761) of worldwide and 90% (968 of 1073) of European fatal clozapine-associated outcomes. In a pharmacovigilance study from the UK database (from 2008 to 2017), clozapine was associated with 383 fatal outcomes/year including all reports from physicians and nonphysicians. From 2018 to 2021, UK clozapine-associated fatal outcomes increased to 440/year. IMPLICATIONS/CONCLUSIONS: The interpretation of fatal outcomes in each country using pharmacovigilance databases is limited and only allows gross comparisons; even with those limitations, the UK data seem concerning. Pneumonia and myocarditis may be more important than agranulocytosis in explaining the uneven distribution of fatal outcomes in clozapine patients across countries.
Asunto(s)

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Antipsicóticos / Clozapina / Agranulocitosis País/Región como asunto: Europa Idioma: En Revista: J Clin Psychopharmacol Año: 2023 Tipo del documento: Article

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Antipsicóticos / Clozapina / Agranulocitosis País/Región como asunto: Europa Idioma: En Revista: J Clin Psychopharmacol Año: 2023 Tipo del documento: Article