Detection and analysis on safety signals of Clonidine Hydrochloride Sustained-Release Tablets for attention deficit hyperactivity disorder based on FAERS database
Objective To mine and analyze the safety warning signals of Clonidine Hydrochloride Sustained-Release Tablets in treatment of attention deficit hyperactivity disorder in the FAERS database,and provide reference for clinical safety medication.Methods"clonidine"or"clonidine hydrochloride"is targeted as the primary suspect,and extracted adverse event reports related to"attention deficit hyperactivity disorder"in the FAERS database from first quarter 2004 to third quarter 2023,using the report odds ratio method(ROR),proportional reporting ratio(PRR),while bayesian confidence progressive neural network(BCPNN)were used for signal detection analysis.Results There were 136 ADE reports with clonidine or clonidine hydrochloride as the main suspected object and the indication corresponding to attention deficit hyperactivity disorder,involving 8 systems and 36 safety warning signals,including the nervous system,cardiovascular system and respiratory system.The main ADE are common sedation,drowsiness,sinus bradycardia,hypotension,withdrawal hypertension,respiratory depression,apnea,etc.In addition,prolongation of QT interval and generalized tonic convulsions not mentioned in the instruction manual were detected,including suicidal behavior,overweight and other ADE signals.Conclusion When using Clonidine Hydrochloride Sustained-Release Tablets clinically,it is necessary to monitor the medication,especially the heart rate and blood pressure.In children with behavioral disorders or brain development,it is also necessary to consider the relationship with this drug,and make a safe and rational use of the drug.
NETL
NSTL
万方数据
维普
