Published: May 2009

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Antiepileptic medicines - increased risk of suicidality

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Prescriber Update 30(2): 11
May 2009

The FDA performed an analysis of reports of suicidality (suicidal behaviour or ideation) from clinical trials of eleven medicines used to treat epilepsy, psychiatric disorders and other conditions (including neuropathic pain). The analysis included 199 placebo-controlled trials involving a total of 43,800 patients¹.

The FDA stated that patients receiving antiepileptic medicines had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.24%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic medicine and continued through 24 weeks.

Patients who were treated for epilepsy, psychiatric disorders and other conditions were all at increased risk for suicidality when compared to placebo. There did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the medicines for psychiatric or other conditions.

The increased risk of suicidal thoughts or behaviour was generally consistent among the eleven medicines with varying mechanisms of action and across a range of indications. This suggests that the risk applies to all antiepileptic medicines used for any indication.

A separate European review of clinical trial data, published literature and post-marketing spontaneous reports of adverse drug reactions also concluded that any antiepileptic medicines may rarely be associated with a small increased risk of suicidal thoughts and behaviour².

All patients who are currently taking or starting an antiepileptic medicine should be closely monitored for notable changes in behaviour that could indicate the emergence or worsening of suicidal thoughts/behaviour or depression. Healthcare professionals should inform patients, their families and caregivers of the potential for an increase in the risk of suicidality and should advise patients to seek medical advice immediately if they develop any symptoms suggestive of suicidality.

The data sheets for all antiepileptic medicines approved in New Zealand are in the process of being updated to include this advice.

References

1. Levenson M. 23 May 2008. Statistical review and evaluation: Anti-epileptic drugs and suicidality. Available from: http://www.fda.gov/ohrms/dockets/ac/08/briefi ng/2008-4372b1- 01 FDA.pdf
2. MHRA. August 2008. Antiepileptics: Risk of suicidal thoughts and behaviour. Drug Safety Update. 2(1):2.