Analysis of serious adverse events related to testosterone treatment
Objective To investigate the association between testosterone replacement therapy(TRT)and serious adverse events,based on the FDA adverse event reporting system(FAERS)database.Method Reporting odds ratio(ROR)and Bayesian confidence propagation neural network were applied to analyze the adverse reaction reports in FAERS database from January 2004 to June 2023.Result A total of 16 702 testosterone users were included according to the including/excluding criteria,and 424 pharmacovigilance signal were detected,among which 155 were strong signals,referring to 29 system organ classes,such as cardiovascular,reproductive,nervous and endocrine systems.The most significant adverse events including polycythemia[ROR 149.10,95%CI 128.65-172.80,lower limit of information component(IC025)6.05],testis atrophy(ROR 114.47,95%CI 89.88-145.79,IC025 4.92),clear cell renal cell carcinoma(ROR 86.97,95%CI 64.47-117.32,IC025 4.23),and acute myocardial infarction(ROR 20.40,95%CI 18.77-22.17,IC025 4.14).Conclusion The serious adverse reactions associated with TRT were mainly thrombosis,serious cardiovascular events and tumor risk,which significantly increased the mortality and disability rate.Health care workers should pay more attention to the potential risk of TRT-related erious adverse events and balance the benefits and risks.