Data mining of adverse drug event signals for quetiapine based on FAERS database
Objective To mine adverse drug event(ADE)signals for quetiapine from the FDA Adverse Event Reporting System(FAERS)database,and provide reference for its safe clinical use.Methods We searched the FAERS database for ADE reports related to quetiapine from 2004 to 2023,79 quarters in total.Several methods were used,including the reporting odds ratio,proportional reporting ratio,Bayesian confidence propagation neural network,and multi-item Gamma poisson shrinker.The ADE reports were categorized and risk signals were grouped based on the preferred terms and system organ classes.Results Totally 261 725 ADE reports were collected in which quetiapine was the primary suspect drug,involving 68 012 patients.The majority of these reports came from females(37 495 reports,55.13％)and over 65 years old(35 312 reports,51.9％),mainly reported in the United States,with outcome often being other serious consequences,hospitalization,death,or life-threatening conditions.Totally 713 positive risk signals for quetiapine were identified,covering 27 system organ classes,basiclly consistent with the insruction in the drug package.The most frequently reported ADE was diabetes,with strong signals.Among those ADEs with more than 500 reports,47 positive risk signals were identified,except rhabdomyolysis,which was not listed in the instruction.The time of ADEs onset induced by quetiapine varied,often occurring within 30 days or a year after the treatment.Conclusion Clinicians should not only monitor the ADEs of quetiapine in the instuction but also be vigilant about those not mentioned.Individualized monitoring plans should be catered based on factors such as gender and age.
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