12-05-2017 | Epilepsy Ireland welcomes new warnings on Irish boxes of sodium valproate (epilim)

'12-05-2017 | Epilepsy Ireland welcomes new warnings on Irish boxes of sodium valproate (epilim)' image

A drug linked to up to 4,000 birth defects in France, according to a recent French government report, will finally be dispensed in Ireland with clear warnings on the outside of the box, in line with other European countries. HPRA has approved the update and Epilepsy Ireland understands the updated packaging (see image below) will be introduced to the market within the next few months.

Last month the campaign group FACS Forum (which Epilepsy Ireland is part of) called on the Health Products Regulatory Authority (HPRA) to urgently ensure that the outer packaging of all products containing sodium valproate, including Epilim, contain clearly visible warnings similar to those used in the UK.

The FACS (Fetal Anti-Convulsant Syndrome) Forum estimates that up to 400 children could have been born in Ireland with a range of physical and developmental disabilities following in-utero exposure to the epilepsy drug over the past four decades.

Peter Murphy, CEO of Epilepsy Ireland said: "This news is long overdue and has been one of FACS Forum's key demands. The most effective way of ensuring that all women and parents of girls taking the drug know the risks is to make it clear on the outside of the box. In recent years, there has been a comprehensive warning on the leaflet inside but many people never read those, especially people on the drug long-term."

The new warning on boxes of sodium valproate (epilim)