Signal mining and analysis of adverse drug events for apremilast based on FAERS database
Objective To mine the safety warning signals of apremilast based on the database of the US FDA Adverse Event Reporting System(FAERS),so as to provide reference for clinical safe use.Methods With the generic drug name"Apremilast",trade name"Otezla",and alias"CC-10004"as keywords,the adverse drug events(ADE)signals of apremilast since its listing(from the second quarter of 2014 to the fourth quarter of 2022)were retrieved through the FAERS database.The reporting odds ratio(ROR)and bayesian confidence propagation neural network(BCPNN)were used to mine and analyze the signals.Results A total of 118 818 ADE reports from apremilast were retrieved,including 75 134 female cases,accounting for 63.23％.The age of patients in ADE report was mostly 19-64 years old(48 917 cases,accounting for 41.17％).These data were mainly reported by pharmacists(40 779 copies,accounting for 34.32％).The United States was the main reporting country(accounting for 94.12％).A total of 3 620 ADE signals were screened out.After excluding the signals of non-drug factors,the top ten ADE signals were diarrhea,nausea,psoriasis,headache,abdominal discomfort,psoriatic arthritis,vomiting,depression,weight loss and rash.All selected ADE signals involved 27 system organ classes(SOC),the main dis-eases of which were Gastrointestinal diseases(62 454 cases),General disorders and administration site conditions(37 214 cases),Skin and subcutaneous tissue disorders(29 823 cases),Nervous system disorders(22 623 cases),Injury,poisoning and procedural complications(16 711 cases),and Musculoskeletal and connective tissue disor-ders(16 292 cases).Conclusion During the treatment of apremilast,special attention should be paid to whether the patients have symptoms of the drug-induced ADE in gastrointestinal discomfort,drug ineffectiveness and psori-asis recurrence.At the same time,the risk of mental illness should be assessed.After starting the treatment,the patients'mental illness should be closely monitored for deterioration,suicide or other abnormal behavior.
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