Evidence map›Paper›PMID 39412691›Full record

ArticleInternational journal of clinical pharmacy2025

Disproportionality analysis of flutamide- or bicalutamide-induced liver injury with and without steroids by using the Japanese Adverse Drug Event Report database.

Tomoyuki Yamada, Saori Tanaka, Takumi Noda, Kazuya Urashima, Ayumi Fujimoto, Yuka Kohda, Ryuji Kato

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Article in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Tomoyuki Yamada *Department of Pharmacy, Osaka Medical and Pharmaceutical University Hospital, Daigaku-machi 2-7, Takatsuki, Osaka, 569-8686, Japan.
Saori Tanaka *Department of Pharmacotherapeutics and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Nasahara 4-20-1, Takatsuki, Osaka, 569-1094, Japan.
Takumi NodaDepartment of Pharmacotherapeutics and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Nasahara 4-20-1, Takatsuki, Osaka, 569-1094, Japan.
Kazuya UrashimaDepartment of Pharmacotherapeutics and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Nasahara 4-20-1, Takatsuki, Osaka, 569-1094, Japan.
Ayumi FujimotoDepartment of Pharmacotherapeutics and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Nasahara 4-20-1, Takatsuki, Osaka, 569-1094, Japan.
Yuka KohdaDepartment of Pharmacotherapeutics and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Nasahara 4-20-1, Takatsuki, Osaka, 569-1094, Japan.
Ryuji KatoDepartment of Pharmacotherapeutics and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Nasahara 4-20-1, Takatsuki, Osaka, 569-1094, Japan. ryuji.kato@ompu.ac.jp.ORCID http://orcid.org/0000-0002-7783-2599

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the mechanism underlying flutamide- or bicalutamide-induced liver injury may be immune related, the details remain unclear. If this mechanism is immune related, steroid use may be considered as a treatment option.

aimDisproportionality analysis was conducted to evaluate the effect of concomitant steroid use on flutamide- and bicalutamide-induced liver injury.

methodMale patients aged 20 years or older who were receiving nonsteroidal anti-androgens from April 2004 to October 2023 were screened from the Japanese Adverse Drug Event Report database. Data on liver injury, age, weight, height, steroid use, obesity, hepatic stenosis, alcohol-related hepatic disorders, hepatitis B and C, and common drugs known to cause drug-induced liver injury were analyzed. Liver injury was defined by the Standardized Medical Dictionary for Regulatory Activities query index (code 20000006, version 27.0).

resultsAmong 142,430 patients, 2,316 were administered nonsteroidal anti-androgens. Reports of liver injury were disproportionate depending on the agents used (reporting odds ratio [ROR], 1.29; 95% confidence intervals [CI], 1.13-1.46), especially among flutamide or bicalutamide users (flutamide: ROR, 6.09; 95% CI, 4.51-8.23; bicalutamide: ROR, 1.24; 95% CI, 1.05-1.48). Multivariable logistic regression analysis correlated steroid use with a lower risk of flutamide- or bicalutamide-induced liver injury (flutamide: odds ratio, 0.07; 95% CI, 0.01-0.52; bicalutamide: odds ratio, 0.45; 95% CI, 0.21-0.96).

conclusionOur findings suggest that flutamide and bicalutamide may increase the risk of liver injury compared to enzalutamide, apalutamide, and darolutamide. Furthermore, our study indicated that steroid use could aid in the management of liver injury.

Indexed as

Adverse Drug Reaction Reporting SystemsAndrogen AntagonistsAnilidesChemical and Drug Induced Liver InjuryFlutamideNitrilesSteroidsTosyl CompoundsAdultAgedAged, 80 and overDatabases, FactualHumansJapanMaleMiddle AgedAndrogen AntagonistsAnilidesbicalutamideFlutamideNitrilesNonsteroidal Anti-AndrogensSteroidsTosyl CompoundsAdverse drug eventBicalutamideChemical and drug induced liver injuryFlutamideJapanese Adverse Drug Event Report databasePharmacovigilanceSteroids

Identifiers

PMID39412691

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.