A WARNING is to be posted on all epilepsy drugs in Europe, including Ireland, following the discovery that the medication heightens the risk of suicidal behaviour in some patients.

A European review of anti-epileptic medications concluded that the drugs can cause “a small risk of suicidal thoughts” and that this side-effect “may be seen as early as one week after starting treatment”.

The Irish Medicines Board (IMB) is currently working on updating the product information on all anti-epileptic medicines to advise people of this risk. The warning will be posted on the drugs by April 2009.

A spokeswoman for the IMB said it was advising healthcare professionals to monitor patients for signs of depression or suicidal thoughts throughout treatment.

The review was prompted by extensive research in America. The US Food and Drug Administration (FDA) analysed almost 200 studies on different anti-epileptic drugs, some of which have been on the market for decades.

The research tracked 28,000 people who had been given the medication, along with another 16,000 who were taking placebos. Suicidal thoughts or behaviour was rare, but was twice as likely in those taking the real drugs.

Overall, four people in the drug-treated groups committed suicide, and none did among the placebo takers. The higher risk of suicidal thoughts and behaviour was observed one week after starting treatment, and continued to at least 24 weeks. The results were consistent for all the different drugs studied.

Last week the FDA announced that it is now requiring all manufacturers to add warnings to their labelling. The European review has also advised all EU member states of the need to add the information onto product labels.

According to the IMB, the new package leaflet will carry the following warning: “A small number of people being treated with anti-epileptics . . . have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.”

Mike Glynn, chief executive of the Irish Epilepsy Association, said: “It is good that people will be made aware of this. But there is a fear that it will stop people from taking their medication, and that, in turn, could put them at high risk of Sudden Unexpected Death in Epilepsy (SUDEP).

“There are 40,000 people with epilepsy in Ireland, and of those 30-40 die every year of SUDEP. If the warning leads to people not taking their medication, it would put them at much greater risk.”

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