Data mining of adverse drug event signals for tenofovir alafenamide based on the FDA adverse event reporting system database
Objective To analyze the adverse drug event signals of tenofovir alafenamide,to provide a reference for the ra-tional and safe clinical use of tenofovir alafenamide.Methods The OpenVigil 2.1 data platform was used to retrieve the FDA adverse event reporting system(FAERS)database.The reporting odds ratio(ROR)method was used to analyze all the adverse events reported as primarily suspected to be related to tenofovir alafenamide from January 1,2017 to September 30,2022.For all the selected adverse events,the characteristics of the population,the number of reports,the distribution of positive signals,and signal strength were analyzed.Results A total of 9025 cases of tenofovir alafenamide-related adverse events were identi-fied,including 6203 males,2271 females,and 551 unspecified.The largest age groups were 45 to 64 and 18 to 44 years.The United States had the highest number of reports,with Japan being the only country in the top five.Among the severe out-comes,hospitalization accounted for the largest proportion,with 410 suspected deaths due to tenofovir alafenamide.A total of 196 positive signals were detected mapping to 21 system/organ classifications,mainly involving various examinations,gastroin-testinal system,psychiatric disorders,various surgical and medical procedures,systemic diseases and reactions of drug deliv-ery sites,skin and subcutaneous tissues,infections and infestations,renal and urinary system diseases,etc.Positive signals of adverse events not included in the package insert included various examinations(CD4 lymphocyte decrease/abnormal/in-crease),endocrine system(diffuse goiter),nervous system(Guillain-Barre syndrome),pregnancy,perinatal period,puerperal period(placenta previa,fetal death)diseases,etc.Conclusion In addition to the adverse events listed in the manual,clini-cians should be vigilant about the impact of tenofovir alafenamide on various examinations,the endocrine system,and the ner-vous system to ensure its safe use in clinical practice.
tenofovir alafenamideadverse eventssignal miningFDA adverse event reporting system database
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万方数据
