Data Mining of Opioids-Induced Constipation Adverse Events Based on FAERS
Objective To promote the rational clinical use of opioids.Methods The drug adverse event(ADE)reports of 11 opioids in the FDA Adverse Event Reporting System(FAERS)from 2004 to 2022 were extracted,and the reporting odds ratio(ROR)and information component(IC)methods were use for data analysis.Results A total of 400 986 cases of reports with opioids as the primary suspected drug were included,including 6 045 cases of constipation events.The quantity of opioids-induced ADE reports and opioids-induced constipation(OIC)events showed an upward trend from 2004 to 2022.The cases of OIC were mainly from the North America(71.65%),and 57.44%were reported by non-health experts.The top five opioids with more reports were oxycodone(2 394 cases),fentanyl(895 cases),buprenorphine(846 cases),morphine(791 cases)and tramadol(596 cases),accounting for over 90%cumulatively.Eight drugs generated signals,among which oxycodone[ROR=1.54,95%CI(1.48,1.61)],fentanyl[ROR=1.33,95%CI(1.24,1.42)],buprenorphine[ROR=1.32,95%CI(1.23,1.41)],morphine[ROR=2.27,95%CI(2.11,2.44)]and tramadol[ROR=2.03,95%CI(1.87,2.20)]were significantly associated with constipation;and the ADE signal intensity increased with age.Oral(oxycodone,morphine,tramadol)and transdermal(fentanyl,buprenorphine)were the main routes of administration in constipation cases.Conclusion There is a correlation between the use of opioids and constipation.We should strengthen monitoring of the gastrointestinal function of elderly patients using opioids for a long time to ensure their medication safety,and improve the quality of pharmaceutical care.
万方数据
维普
