Background:The purpose of this study was to analyze and classify adverse drug events(ADEs)related to ceftazidime/avibactam reported in the Food and Drug Administration Adverse Event Reporting System(FAERS)database and...Background:The purpose of this study was to analyze and classify adverse drug events(ADEs)related to ceftazidime/avibactam reported in the Food and Drug Administration Adverse Event Reporting System(FAERS)database and to evaluate their potential safety signals since the drug’s market introduction.Methods:This analysis systematically extracted and filtered FAERS data for ceftazidime/avibactam from its market launch in 2015 to the last quarter of 2024,utilizing the Medical Dictionary for Regulatory Activities(MedDRA)terminology for ADE recoding.The analysis employed the reporting odds ratio(ROR)method to assess the strength of ADE signals and to identify significant diseases associated with infections,the hepatobiliary system,the urinary system,and the nervous system.Results:A review of 540 adverse reaction reports revealed significant signals of adverse effects related to infections,hepatobiliary disorders,urinary system issues,and neurological impairments,including pathogen resistance,liver and kidney function impairment,encephalopathy,thrombocytopenia,and toxic epidermal necrolysis.However,these issues require further clinical attention.Conclusion:Ceftazidime/avibactam is associated with a range of adverse reactions,necessitating enhanced clinical monitoring,particularly in patients with underlying liver or kidney dysfunction.Continuous risk assessment and vigilant monitoring are critical for its clinical use.However,this study is limited by inherent reporting biases and confounders associated with the spontaneous reporting database(FAERS).Future research should validate these signals through prospective cohort and mechanistic studies and explore personalized risk management strategies for high-risk populations.展开更多
基金Intramural Project of The First Affiliated Hospital of Guangxi University of Chinese Medicine(2018QN008).
文摘Background:The purpose of this study was to analyze and classify adverse drug events(ADEs)related to ceftazidime/avibactam reported in the Food and Drug Administration Adverse Event Reporting System(FAERS)database and to evaluate their potential safety signals since the drug’s market introduction.Methods:This analysis systematically extracted and filtered FAERS data for ceftazidime/avibactam from its market launch in 2015 to the last quarter of 2024,utilizing the Medical Dictionary for Regulatory Activities(MedDRA)terminology for ADE recoding.The analysis employed the reporting odds ratio(ROR)method to assess the strength of ADE signals and to identify significant diseases associated with infections,the hepatobiliary system,the urinary system,and the nervous system.Results:A review of 540 adverse reaction reports revealed significant signals of adverse effects related to infections,hepatobiliary disorders,urinary system issues,and neurological impairments,including pathogen resistance,liver and kidney function impairment,encephalopathy,thrombocytopenia,and toxic epidermal necrolysis.However,these issues require further clinical attention.Conclusion:Ceftazidime/avibactam is associated with a range of adverse reactions,necessitating enhanced clinical monitoring,particularly in patients with underlying liver or kidney dysfunction.Continuous risk assessment and vigilant monitoring are critical for its clinical use.However,this study is limited by inherent reporting biases and confounders associated with the spontaneous reporting database(FAERS).Future research should validate these signals through prospective cohort and mechanistic studies and explore personalized risk management strategies for high-risk populations.
