Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (2): 189-192.
DOI: 10.19803/j.1672-8629.2022.02.16

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Evaluation and significance of benefit-risk analysis of benzbromarone-induced liver injury

WANG Yi, REN Jingtian*   

  1. Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China
  • Received:2021-07-14 Online:2022-02-15 Published:2022-02-15

Abstract: Objective To analyze the benefit-risk of DILI caused by benzbromarone and to provide reference for its safe use. Methods The adverse reactions to benzbromarone recorded in the National ADR Database from building to June 30, 2020 and the UMC database from building to August 9, 2020 and related literature were collected and analyzed. Results A total of 874 reports of DILI were retrieved from spontaneous reports of adverse reactions to benzbromarone received from the real world in both domestic and international adverse reaction monitoring databases. Patients were mostly males aged 18 to 64. Adverse reactions were mostly described as abnormal liver function and elevated aminotransferase. The outcome of domestic patients was good. Conclusion There is the risk of DILI from benzbromarone. Strengthening intervention and monitoring of liver function can effectively help prevent serious DILI.

Key words: benzbromarone, drug-related liver injury, ADR monitoring, benefit-risk

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