The European Medicines Agency (EMEA) has concluded that antiepileptics may entail a slight risk of suicidal thoughts and behaviour.
EMEA has reviewed data from clinical trials, spontaneous adverse reaction reports submitted after the products were marketed as well as literature reports dealing with the following antiepileptics: Carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, vigabatrin and zonisamide.
It has not been possible to determine whether the different antiepileptic medicines cause varying degrees of risk or if the risk entailed is the same for all of the products.
The product information of all antiepileptics will be updated, so that this potentially increased risk of suicidal thoughts and behaviour is included.
Please see the factbox to the right to learn more.
For further information, please contact the Consumer Safety Division on tel.: +45 4488 9757.
Danish Medicines Agency, 7 August 2008