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Comparison of agranulocytosis and anti-neutrophil cytoplasmic antibody-associated vasculitis caused by two antithyroid drugs: A pharmacovigilance study using the WHO international database

Authors
 Ji Yun Han  ;  Jun Myong Lee  ;  Se Yong Jung  ;  Min Seo Kim  ;  Seung Won Lee  ;  Andreas Kronbichler  ;  Kalthoum Tizaoui  ;  Ai Koyanagi  ;  Eun Young Kim  ;  Kyungchul Song  ;  Hyun Wook Chae  ;  Dong Keon Yon  ;  Jae Il Shin  ;  Lee Smith 
Citation
 FUNDAMENTAL & CLINICAL PHARMACOLOGY, Vol.38(4) : 780-788, 2024-08 
Journal Title
FUNDAMENTAL & CLINICAL PHARMACOLOGY
ISSN
 0767-3981 
Issue Date
2024-08
MeSH
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems / statistics & numerical data ; Aged ; Agranulocytosis* / chemically induced ; Agranulocytosis* / epidemiology ; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis* / chemically induced ; Antithyroid Agents* / adverse effects ; Databases, Factual* ; Female ; Humans ; Male ; Methimazole* / adverse effects ; Middle Aged ; Pharmacovigilance* ; Propylthiouracil* / adverse effects ; World Health Organization ; Young Adult
Keywords
ANCA‐associated vasculitis ; Antithyroid drugs ; agranulocytosis ; methimazole ; pharmacovigilance study ; propylthiouracil
Abstract
BackgroundMethimazole (MMI) and propylthiouracil (PTU) are commonly used for patients with thyrotoxicosis. Agranulocytosis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is associated with high morbidity and mortality, requiring appropriate interventions. In this study, we compared adverse drug effects associated with MMI and PTU using a real-world large pharmacovigilance database.MethodsWe searched all Individual Case Safety Reports reported to be associated with MMI and PTU, from VigiBase between 1967 and June 2, 2021. We conducted disproportionality analysis (case/non-case analysis) to analyze the difference in reported adverse drug reactions (ADRs) between antithyroid drugs (case) and the entire database (non-cases). We further analyzed information for the cases of agranulocytosis and AAV.ResultsAmong 11 632 cases of ADRs reported after MMI intake, agranulocytosis occurred in 1633 cases and AAV occurred in 41 cases. For 5055 cases of ADRs reported after PTU intake, agranulocytosis occurred in 459 cases and AAV occurred in 110 cases. Agranulocytosis occurred after a median of 28 days after PTU intake and 33 days after MMI intake. More than 95% of the agranulocytosis cases were classified as serious, but most of them (65.1% for PTU and 70.4% for MMI) were reported to have recovered after dechallenge actions; mostly drug withdrawal. AAV occurred after a median of 668 days after PTU intake, and 1162 days after MMI intake.ConclusionsThis is a pharmacoepidemiological study investigating agranulocytosis and AAV caused by MMI and PTU. Through this research, we could provide more specific insights into a safe prescription of antithyroid drugs in a real-world setting.
Full Text
https://onlinelibrary.wiley.com/doi/10.1111/fcp.12991
DOI
10.1111/fcp.12991
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
Yonsei Authors
Song, Kyungchul(송경철) ORCID logo https://orcid.org/0000-0002-8497-5934
Shin, Jae Il(신재일) ORCID logo https://orcid.org/0000-0003-2326-1820
Jung, Se Yong(정세용) ORCID logo https://orcid.org/0000-0003-1337-563X
Chae, Hyun Wook(채현욱) ORCID logo https://orcid.org/0000-0001-5016-8539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/201072
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