Analysis of risk signals of doxycycline in different age groups based on the FDA Adverse Event Reporting System database
AIM To mine and analyze the adverse event(AE)signals of doxycycline in patients of different age groups based on the FDA Administration Adverse Event Reporting System(FAERS)database,to provide references of the clinical safety information.METHODS AE reports of doxycycline from the FAERS database during the first quarter of 2004 to the third quarter of 2023 were collected.The AE reports of doxycycline were mined by using the reporting odds ratio(ROR),proportional reporting ratio(PRR),and the comprehensive standard method established by the Medicines and Healthcare Products Regulatory Agency(referred to as MHRA method),and key signals of AE in different age groups were deeply analyzed.RESULTS A total of 13 603 AE reports of doxycycline were retrieved,involving 39920 AE occurrences,which resulted in 517 positive signals mapped to 26 systems organ classification(SOC).In adults aged 18 and above,common AEs such as drug-induced hypersensitivity,nausea,vomiting,rash,and photosensitivity were consistent with the drug instructions.For the age group of 8 to 17 years,AEs included those documented in the instructions such as vomiting,nausea,esophageal ulcers,esophagitis and ulcerative colitis,as well as undocumented AEs like Jarisch-Herxheimer reaction,sclerosing cholangitis,depression,and suicidal ideation.In children under 8 years old,rare AEs explicitly warned in drug instruction,such as tooth discoloration and increased intracranial pressure,along with undocumented AEs like methemoglobinemia and metabolic acidosis were observed.CONCLUSION During clinical use of doxycycline,attention should be paid not only to common gastrointestinal,dermatological,and immune system AEs but also to rare or undocumented potential AEs in the instructions,especially in children under 8 years old,it is crucial to focus on the safety of off-label drug use to prevent severe irreversible damage and ensure patient medication safety.
万方数据
维普
