A Europe-wide review of data from clinical trials, published literature and post-marketing reports concluded that any antiepileptic drug might rarely be associated with a small increased risk of suicidal thoughts and behaviour.
The review of data also included an FDA data analysis of placebo-controlled trials for 11 antiepileptic drugs, which showed that patients receiving antiepileptics had approximately twice the risk of suicidal thoughts and behaviour (0.43%) compared to placebo (0.22%). The increased risk was seen as early as one week after starting treatment.
The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics and the MHRA has decided that prescribing information for all antiepileptics must be updated.
Prescribers will need to advise patients to be alert to any mood changes, distressing thoughts or feelings about suicide or harming themselves at any point during treatment. Patients should also be advised not to stop or switch treatment on the basis of this information without discussion with their healthcare provider
Further information: MHRA