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:

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

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.