Fluoxetine and adult suicidality revisited: an updated meta-analysis using expanded data sources from placebo-controlled trials.
Selective serotonin reuptake inhibitor treatments have been suggested by some to induce emergence of suicidality (ideation and behaviors). The objective of this study was to assess suicidality emergence by adverse event and rating scale data in the largest available, adult, major depression, double-blind, placebo-controlled, fluoxetine trial database (18 trials). Adverse event reports and comments for patients (fluoxetine, n = 2200; placebo, n = 1551) were searched for suicide-related events that were then classified into Food and Drug Administration categories. For 16 trials, suicidality was also examined by Hamilton Depression Scale item 3 (suicide) scores, and these data were analyzed along with the combination of event-based data and scale-based data. Comparisons between treatments were made for various estimates of worsening (risk) and improvement (benefit) of suicidality. Fluoxetine treatment did not result in greater worsening but was associated with greater improvement and faster resolution of ideation (P < or = 0.05 vs placebo). Data sources were differentially sensitive in detecting changes in suicidal ideation and behaviors. Fluoxetine treatment led to greater benefit rather than risk for suicidality.
Beasley
Charles M
CM
Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. cmbeasleyj@lilly.com
Ball
Susan G
SG
Nilsson
Mary E
ME
Polzer
John
J
Tauscher-Wisniewski
Sitra
S
Plewes
John
J
Acharya
Nayan
N
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D003625:Data Collection / Q000379:methods*; D003865:Major Depressive Disorder / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D005473:Fluoxetine / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D010045:Outpatients / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013405:Suicide / Q000523:psychology / Q000706:statistics & numerical data*; D014481:United States
D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors