The present study attempted to identify risk factors for suicidality and hostility/aggression in patients with bipolar disorders. Data on 3521 patients were extracted from the Japanese Adverse Drug Event Report (JADER) database. There were 134 reports regarding suicidal behavior/ideation, and 129 patients were judged to have it. Standardized Medical Dictionary for Regulatory Activities queries indicated that 248 adverse drug events pertained to hostility/aggression, and 218 patients were considered to show hostility/aggression. A multiple logistic regression analysis revealed the association of the risk for suicidal behavior/ideation with bipolar II disorder [adjusted odds ratio (aOR): 4.55, 95% confidence interval (CI): 1.90-10.9], male sex (aOR: 1.23, 95% CI: 1.02-1.48), age <50 years (aOR: 1.75, 95% CI: 1.43-2.15), the administration of aripiprazole (aOR: 1.27, 95% CI: 1.00-1.60), and akathisia (aOR: 3.05, 95% CI: 1.80-5.18), while lithium carbonate decreased its odds (aOR: 0.664, 95% CI: 0.537-0.821). The risk of hostility/aggression was associated with male sex (aOR: 1.22, 95% CI: 1.06-1.40), lithium carbonate (aOR: 0.823, 95% CI: 0.710-0.953), and carbamazepine (aOR: 0.693, 95% CI: 0.500-0.961). No association between suicidal behavior/ideation and hostility/aggression was recognized. The present study proposes factors related with suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders using the JADER database. Lithium carbonate appeared to decrease the risks of suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders, and akathisia may be associated with the former risk. Further studies are required to evaluate the identified signals.
Keywords: Bipolar disorder; Hostility/aggression; Japanese adverse drug event report database; Lithium carbonate; Multiple logistic regression analysis; Suicidal behavior/ideation.
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