title: Association between Selective Serotonin Reuptake Inhibitor Therapy and Suicidality: Analysis of U.S. Food and Drug Administration Adverse Event Reporting System Data.
abstract: Selective serotonin reuptake inhibitors (SSRIs) are prescribed for the treatment of depression worldwide. SSRIs are suspected to increase the risk of suicidal ideation and behavior (suicidality) in children, adolescents, and young adults. We examined the association between SSRI therapy and suicidality by applying a logistic regression model to age-stratified data from the Food and Drug Administration (FDA) Adverse Event Reporting System database. We attempted to mitigate the effect of patient-related factors by data subsetting. We selected case reports for SSRIs as referred to in the World Health Organization Anatomical Therapeutic Chemical classification code N06AB. The association between SSRIs and "suicidal events" or "self-harm events" was calculated as a reporting odds ratio (ROR) and adjusted for covariates by logistic regression. For subjects <18 years old (y.o.) the adjusted RORs (95% confidence interval) of SSRI therapy with suicidal events were 9.58 (8.97-10.23) in the whole data analysis and 4.64 (4.15-5.19) in the subset analysis; those with self-harm events were 31.40 (27.71-35.58) and 16.31 (13.12-20.29), respectively. Although the adjusted RORs were lower in the subset analyses than in the whole data analyses, both analyses indicated associations between SSRI treatment and suicidal and self-harm events. In both analyses these associations were stronger in the <18 y.o. group than other age groups. Children and adolescents should be closely monitored for the occurrence of suicidality when they are prescribed SSRIs. In addition, we found that data subsetting might mitigate the effect of an intrinsic risk among patients taking the suspected drug.
authors.affiliation: Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Ryogo
authors.initials: R
authors.lastname: Umetsu
authors.forename: Junko
authors.initials: J
authors.lastname: Abe
authors.forename: Natsumi
authors.initials: N
authors.lastname: Ueda
authors.forename: Yamato
authors.initials: Y
authors.lastname: Kato
authors.forename: Toshinobu
authors.initials: T
authors.lastname: Matsui
authors.forename: Yoko
authors.initials: Y
authors.lastname: Nakayama
authors.forename: Yasutomi
authors.initials: Y
authors.lastname: Kinosada
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Nakamura
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D002648:Child; D016208:Databases, Factual; D003863:Depression / Q000150:complications / Q000188:drug therapy*; D003866:Depressive Disorder / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012307:Risk Factors; D016728:Self-Injurious Behavior; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D013405:Suicide / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors