The FDA has analysed reports of suicidal behaviour (completed suicides, suicide attempts and preparatory acts) or having suicidal ideas from nearly 200 studies of 11 AEDs. In the analysis, patients taking AEDs had approximately twice the risk of suicidal behavior or ideas (one person in 232) compared to patients taking a placebo (one person in 454).
The increased risk of suicidal behavior ideas was seen as early as one week after starting the AEDs and continued through 24 weeks. The results were generally consistent among the eleven drugs. Four of the patients who were taking one of the AEDs committed suicide, whereas none of the patients in the placebo group did.
As most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The FDA has suggested to healthcare professionals that all patients who are currently taking or starting on any AED should be closely monitored for notable changes in behaviour that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.