Escaping the Long Shadow Cast by Agranulocytosis : Reflections on Clozapine Pharmacovigilance Focused on the United Kingdom
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
|---|---|
| Enthalten in: |
Journal of clinical psychopharmacology - 43(2023), 3 vom: 01. Mai, Seite 239-245 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
de Leon, Jose [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Completed 03.05.2023 Date Revised 03.05.2023 published: Print Citation Status MEDLINE |
|---|
| doi: |
10.1097/JCP.0000000000001678 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM355720639 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM355720639 | ||
| 003 | DE-627 | ||
| 005 | 20231226064935.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1097/JCP.0000000000001678 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1185.xml |
| 035 | |a (DE-627)NLM355720639 | ||
| 035 | |a (NLM)37068034 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a de Leon, Jose |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Escaping the Long Shadow Cast by Agranulocytosis |b Reflections on Clozapine Pharmacovigilance Focused on the United Kingdom |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 03.05.2023 | ||
| 500 | |a Date Revised 03.05.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Clozapine |2 NLM | |
| 650 | 7 | |a J60AR2IKIC |2 NLM | |
| 650 | 7 | |a Antipsychotic Agents |2 NLM | |
| 700 | 1 | |a Arrojo-Romero, Manuel |e verfasserin |4 aut | |
| 700 | 1 | |a Verdoux, Hélène |e verfasserin |4 aut | |
| 700 | 1 | |a Ruan, Can-Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Schoretsanitis, Georgios |e verfasserin |4 aut | |
| 700 | 1 | |a Rohde, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Cohen, Dan |e verfasserin |4 aut | |
| 700 | 1 | |a Schulte, Peter F J |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Se Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Cotes, Robert O |e verfasserin |4 aut | |
| 700 | 1 | |a Leung, Jonathan G |e verfasserin |4 aut | |
| 700 | 1 | |a Otsuka, Yuji |e verfasserin |4 aut | |
| 700 | 1 | |a Kirilochev, Oleg O |e verfasserin |4 aut | |
| 700 | 1 | |a Baptista, Trino |e verfasserin |4 aut | |
| 700 | 1 | |a Grover, Sandeep |e verfasserin |4 aut | |
| 700 | 1 | |a Every-Palmer, Susanna |e verfasserin |4 aut | |
| 700 | 1 | |a Clark, Scott R |e verfasserin |4 aut | |
| 700 | 1 | |a McGrane, Ian R |e verfasserin |4 aut | |
| 700 | 1 | |a Motuca, Mariano |e verfasserin |4 aut | |
| 700 | 1 | |a Olmos, Ismael |e verfasserin |4 aut | |
| 700 | 1 | |a Wilkowska, Alina |e verfasserin |4 aut | |
| 700 | 1 | |a Sagud, Marina |e verfasserin |4 aut | |
| 700 | 1 | |a Anil Yağcioğlu, A Elif |e verfasserin |4 aut | |
| 700 | 1 | |a Ristic, Dragana Ignjatovic |e verfasserin |4 aut | |
| 700 | 1 | |a Lazary, Judit |e verfasserin |4 aut | |
| 700 | 1 | |a Sanz, Emilio J |e verfasserin |4 aut | |
| 700 | 1 | |a De Las Cuevas, Carlos |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical psychopharmacology |d 1993 |g 43(2023), 3 vom: 01. Mai, Seite 239-245 |w (DE-627)NLM012629219 |x 1533-712X |7 nnns |
| 773 | 1 | 8 | |g volume:43 |g year:2023 |g number:3 |g day:01 |g month:05 |g pages:239-245 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1097/JCP.0000000000001678 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 43 |j 2023 |e 3 |b 01 |c 05 |h 239-245 | ||