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9-6-2009 | Update on changes to AED labeling in Ireland concerning increased suicidal tendencies

10 June 2009
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As previously reported by Brainwave, The FDA in the US confirmed recently that they would be putting new warnings on the labels of anti-epilepsy drugs (AEDs) about heightened risks of suicidal tendencies. This was following a review there that concluded that an additional two patients per 1,000 would have suicidal thoughts and behaviors when taking AED's compared with placebo.

The FDA decided not to add its sternest 'black box' warning to the medications, following concerns that these warnings could cause undue alarm among patients and cause them to stop taking their medications.

This issue has also been reviewed at a European level comprising of assessments of clinical trial data, spontaneous adverse reaction reports and other literature reports. In relation to each particular medication, throughout Europe warnings and/or additional information are being included in to the patient information and summary of product characteristics documentation relating to each product. We understand from the Irish Medicines Board (www.imb.ie) that this process is almost complete.

The European review concluded that it was not possible to determine whether the risk of suicidal thoughts and behaviour differs between antiepileptic medicines. Furthermore, the mechanism by which antiepileptic medicines may increase the risk of a patient having suicidal thoughts and behaviour is not known. As a result, the product information for ALL antiepileptic medicines is being updated to reflect the currently available information for the potential risk of suicidal thoughts and behaviour.

Below is the updated information that will appear:

Summary of Product Characteristics

'Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for <drug substance>. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge."

Package Leaflet

'A small number of people being treated with antiepileptics such as << drug substance >> have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.'

Brainwave agrees that people on AED's should be made aware of these risks, but we must also re-iterate that you must not stop or reduce your epilepsy medication because of these warnings. The risks associated with this (e.g. breakthrough seizures causing accidents, increased risk of SUDEP) far outweigh the risk of suicide or suicidal behaviour. Please speak with your doctor if you have any concerns or contact us for further information.

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