Deputy Pauline Tully (SF).

Families affected by epilepsy drug must be looked after – Tully

A package of measures must be delivered for families whose children were left with disabilities due to exposure in the womb to a drug used to treat epilespy. The issue was raised in Dáil Éireann last week by Sinn Fein TD Pauline Tully who advocated for those affected by the drug Valproate.

“A disability package was promised to people affected by Valproate,” she said.

Listed by the World Health Organisation (WHO) as an essential medicine, sodium valproate is an important drug in the treatment of epilepsy. It is manufactured by Sanofi and marketed in Ireland under the brand name Epilim. It causes developmental disability and congenital malformation in 30-40% of children exposed to it in the womb.

“A number of years ago, the affected people and families obtained a report from a genetics doctor, which was submitted to the CHO area in which they live.

“They were told a liaison officer would be appointed to engage with those concerned to identify the supports required to address their needs,” contended Deputy Tully.

“Despite this announcement of a number of years ago, no packages have been put in place. We are talking about approximately 1,200 people, although there could be over 3,000 potentially impacted,” said the Cavan Monaghan TD. She urged the Government to follow up with the HSE on packages for the people affected.

“Sinn Féin will continue to hold the Government to their previous commitments on this issue until it is resolved,” said Deputy Tully.

The European Medicines Agency (EMA) strengthened warnings on valproate-based medicines in 2014 but a further review in 2017 found warnings were still not effective enough. Sodium valproate is now contraindicated in women and girls of childbearing potential, unless a pregnancy-prevention plan is in place, and may be prescribed only when other treatments are not suitable.

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