30th January 2009
A small risk of suicidal thoughts and behaviour has recently been found to be associated with all antiepileptic medicines (about 2 additional patients per 1000). The EMEA has recommended that the product information for these agents is updated to warn of this.
Healthcare professionals should continue to follow MHRA advice and NICE guidance on epilepsy. Patients taking antiepileptics (and their carers) should be advised to seek medical advice if they develop any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment. Such patients should be referred for appropriate treatment if necessary and advised against stopping or switching treatment without talking to a healthcare professional first.
What is this about and what is the background? –
The EMEA CHMP meeting held in December 2008 concluded that the product information of all antiepileptic medicines used in the European Union (EU) should be updated with appropriate information about the small risk of suicidal thoughts and behaviour with treatment. This follows a review of all antiepileptic medicines available in the EU that was carried out by the Pharmacovigilance Working Party. The review suggested that treatment with antiepileptic medicines is associated with a small risk of suicidal thoughts and behaviour, but this risk does not outweigh the benefits of these treatments.
In August 2008, the MHRA reported on the findings of this review and issued recommendations for healthcare professionals. The review was based on information from clinical trials, information reported in the scientific literature, and from databases that recorded spontaneous reports of side effects in people who had taken an antiepileptic. A recent review of antiepileptics and suicidality that was carried out by the FDA was also considered in the European review. This FDA review looked at 199 placebo-controlled trials (n=43,800) involving 11 antiepileptic drugs used for epilepsy, psychiatric disorders or other disorders (e.g. neuropathic pain). 0.43% of patients taking antiepileptics had suicidal thoughts and behaviour compared with 0.22% of patients taking placebo. An increased risk was generally seen for all drugs studied but there did not appear to be any obvious pattern of risk across specific patients or age-groups. To put this small risk into context, approximately two additional patients per 1000 in the antiepileptic group had such an event compared with those in the placebo group.
The product information for many antiepileptics has already been updated to reflect the small risk of suicidal thoughts and behaviour. When prescribing antiepileptics, healthcare professionals should continue to follow MHRA advice:
- Antiepileptic treatment is associated with a small risk of suicidal thoughts and behaviour; available data suggest that the increased risk applies to all antiepileptics and is seen as early as one week after starting treatment.
- Patients should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment. They should be advised to seek medical advice if they develop such thoughts or behaviour, and should be referred for appropriate treatment if necessary.
The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics. Patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.