Signal mining and analysis of adverse drug events of ferric carboxymaltose based on FDA adverse event reporting system database
Objective To explore and analyze the adverse drug event(ADE)signals of carboxymaltose iron after its market launch,and provide a reference for the clinical safety of drug use.Methods The ADE reports of ferric carboxymaltose from the first quarter of 2013 to the third quarter of 2023 were collected from the FDA adverse event reporting system(FAERS)database.For data mining and analysis,the reporting odds ratio(ROR)method and medicines and healthcare products regulatory agency(MHRA)method in the proportional imbalance method were utilized.Results A total of 6685 ADEs reports with ferric carboxymaltose as the primary subject were extracted.A total of 206 ADEs signals were detected involving 13 152 ADEs cases and 20 system organ classes(SOCs).The 20 SOCs mainly concentrated on general disorders and administration site conditions,skin and subcutaneous tissue disorders,nervous system disorders,musculoskeletal and connective tissue disorders,respiratory,thoracic and mediastinal disorders,and gastrointestinal disorders.Among the top 20 preferred terms(PTs)in the signal number list,the top 10 PTs included hypophosphataemia,nausea,dyspnoea,headache,dizziness,pruritus,urticaria,anxiety,arthralgia and myalgia,all of which were mentioned in the drug instruction.PTs such as emotional distress,anhedonia and chest discomfort were not mentioned in the drug labels.Among the top 20 PTs in the signal intensity list,the top 10 PTs included fibroblast growth factor-23(FGF-23)increased,hypophosphataemia,infusion site discolouration,hyperphosphaturia,urine phosphorus increased,Fishbane reaction,blood phosphorus decreased,hypophosphataemic osteomalcia,serum 1,25-dihydroxycholecalciferol decreased and discoloration at the site of administration.FGF-23 increased,urine phosphorus increased,Fishbane reaction,serum 1,25-dihydroxycholecalciferol decreased and discoloration at the site of administration were not mentioned in the drug labels.Conclusion ADE risk signals that occurred more frequently were generally consistent with the information in the drug labels.It is recommended that patients with chronic diseases,metabolic alkalosis and other factors that can cause hypophosphatemia should avoid using ferric carboxymaltose.It is recommended to slow down the infusion rate of ferric carboxymaltose.
ferric carboxymaltoseFDA adverse event reporting systemdata miningadverse drug event
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