Epidemiological Analysis of Lacosamide-related Adverse Drug Reactions Based on OpenFDA
Objective:To explore the clinical characteristics of adverse drug reactions(ADRs)related to lacosamide based on OpenFDA,a public database of U.S.Food and Drug Administration,and provide a reference for the clinically safe medication of lacosamide.Methods:All information on lacosamide-related ADRs from January 1,2004 to February 1,2023 was searched in the OpenFDA database using"lacosamide"as the key word to analyze its epidemiological characteristics.Results:A total of 10 510 patients with lacosamide-related ADRs were searched from the OpenFDA database,of which,the number of reported patients increased significantly since 2018.Among all lacosamide-related ADRs,most of ADRs were of"serious"(9 170 patients,87.25%),and only a small number of patients(1 340 patients,12.75%)were of"ordinary".The lacosamide-related ADRs were mainly manifested as various neurological symptoms,followed by systemic or administration site discomforts or abnormalities and psychiatric symptoms.Among 10 510 patients with lacosamide-related ADRs,the outcomes of 1 011 patients were death and 76 patients had sequelae.Conclusion:Most of the lacosamide-related ADRs are serious,and even cause deaths.Therefore,it is necessary to strengthen the clinical medication monitoring when lacosamide is used for treatment,to avoid or reduce the occurrence of serious adverse outcomes.
lacosamideOpenFDAadverse drug reactionepidemiological characteristics