Data mining of tetracyclines ADR signals in children under 8 based on FAERS database
Objective To determine the clinical safety of tetracyclines(tetracycline,minocycline,doxycycline,and tigecycline)for children with mycoplasma pneumoniae pneumonia(MPP)by data mining of adverse drug reaction(ADR)signals based on FAERS database.Methods ADR data in the FAERS database for children under 8 years old from the first quarter of 2004 to the second quarter of 2023 were collected with Open Vigi1 2.1 tool.The data were encoded with the Preferred Terms(PT)from the International Medical Dictionary for Drug Regulatory Activities(MedDRA),and were classified by System/Organ Class(SOC).ADR signal mining of the four tetracycline drugs was conducted with frequency method and Bayesian method,and the main characteristics of their ADR signals were analyzed.Results Totally 820 ADR reports were retrieved from the FAERS database,including 83 for tetracycline,66 for minocycline,352 for doxycycline,and 319 for tigecycline.Totally 63 ADR signals were obtained with both frequency method and Bayesian method,involving 16 SOC,302 PT reports.The most common was gastrointestinal diseases,followed by general disorders and administration site conditions,and various tests and hepatobiliary disorders ranked third.Four PTs involved the tooth related ADR signals,which was the most common ADR signals of tetracyclines,with a total of 29 reports.The signal intensity of tooth discolouration by doxycycline was obviously weaker than that of tetracycline.Minocycline had the strongest signal of blood cholesterol increased.Tigecycline exhibited a unique ADR signals of cardiac disorders in children under 8 years old.Conclusion Tetracyclines are not recommended for children under 8 years old.For children with MPP who are resistant to macrolides,tetracyclines may be used as an alternative treatment,but ADR must be strictly monitored,with doxycycline as the first choice.
万方数据
维普
