Safety Information

Revised: 26 June 2013

Anti-epileptics - Monitor patients for increased risk of suicidality

1 February 2008

Advice from Medsafe

Medsafe is writing to advise that the Food and Drug Administration (FDA) in the United States has released an alert to healthcare professionals about an increased risk of suicidal thoughts and behaviours in patients taking anti-epileptic medicines.

The FDA analysed reports of suicidality (suicidal behaviour or ideation) from placebo-controlled clinical studies (total of 43,892 patients) of eleven medicines used to treat epilepsy as well as psychiatric disorders, and other conditions.

In the FDA's analysis:

• Patients receiving anti-epileptic medicines had approximately twice the risk of suicidal behaviour or ideation (0.43%) compared to patients receiving placebo (0.22%).
• There were an estimated 2.1 per 1000 (95% CI: 0.7, 4.2) more patients in the anti-epileptic treatment groups who experienced suicidal behaviour or ideation than in the placebo groups.
• The increased risk of suicidal behaviour and suicidal ideation was observed as early as one week after starting the anti-epileptic medicine and continued through 24 weeks.
• The results were generally consistent among the eleven medicines.
• Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed.

The FDA expects that all medicines in the anti-epileptic class share the increased risk of suicidality. Therefore, the FDA advises that:

• All patients who are currently taking or starting any anti-epileptic should be closely monitored for notable changes in behaviour (such as anxiety, agitation, hostility, mania and hypomania) that could indicate the emergence or worsening of suicidal thoughts or behaviour or depression.
• Healthcare professionals should inform patients, their families, and caregivers of the potential for an increase in the risk of suicidality so they are aware and able to immediately notify their doctor of any unusual behavioural changes.
• Patients who are currently taking anti-epileptic medicines should not make any changes without first talking to their doctor.

More information from the FDA

Medsafe has contacted the sponsors of anti-epileptics available in New Zealand to request that the data sheets be updated to include warnings about the increased risk of suicidality. Additionally, the Medicines Adverse Reactions Committee will review this issue at its March 2008 meeting. In the interim, Medsafe advises New Zealand prescribers to follow the FDA's advice. Medsafe will inform health professionals of any further developments.