CONTEXT: On January 31, 2008, the Food and Drug Administration issued an alert 
regarding increased risk of suicidal thoughts and behavior related to use of 
antiepileptic drugs (AEDs). On July 10, 2008, a Food and Drug Administration 
scientific advisory committee voted that, yes, there was a significant positive 
association between AEDs and suicidality but voted against placing a black box 
warning on AEDs for suicidality.
OBJECTIVE: To determine if AEDs increase the risk of suicide attempt in patients 
with bipolar disorder.
DESIGN: A pharmacoepidemiologic study in which suicide attempt rates were 
compared before and after treatment and with a medication-free control group. 
Analyses were restricted to AED and lithium monotherapy.
SETTING: We used the PharMetrics medical claims database to study the 
relationship between the 11 AEDs identified in the FDA alert, and lithium, to 
suicide attempts.
MAIN OUTCOME MEASURE: Suicide attempts. Patients A cohort of 47 918 patients 
with bipolar disorder with a minimum 1-year window of information before and 
after the index date of their illness.
RESULTS: Overall, there was no significant difference in suicide attempt rates 
for patients treated with an AED (13 per 1000 person-years [PY]) vs patients not 
treated with an AED or lithium (13 per 1000 PY). In AED-treated subjects, the 
rate of suicide attempts was significantly higher before treatment (72 per 1000 
PY) than after (13 per 1000 PY). In patients receiving no concomitant treatment 
with an antidepressant, other AED, or antipsychotic, AEDs were significantly 
protective relative to no pharmacologic treatment (3 per 1000 vs 15 per 1000 
PY).
CONCLUSIONS: Despite Food and Drug Administration reports regarding increased 
risk of suicidality associated with AED treatment, the current study reveals 
that, as a class, AEDs do not increase risk of suicide attempts in patients with 
bipolar disorder relative to patients not treated with an AED or lithium. Use of 
AEDs reduces suicide attempt rates both relative to patients not receiving any 
psychotropic medication and relative to their pretreatment levels.