Epilepsy drug may be linked to brain defect in over 1,200 babies

More than 1,500 children may have suffered some form of brain development problem or physical disability because their mother took a drug used to treat epilepsy and bipolar disorder during pregnancy, according to the HSE.

The drug Valproate – marketed in Ireland under the brand name Epilim – may be linked to 1,250 children who suffered brain development delay and up to 341 more being born with physical defects, the analysis reveals.

Healthcare experts gathered at a conference in Dublin yesterday to discuss the impact of these conditions, which are known as foetal Valproate syndrome.

The European Medicines Agency’s pharmacovigilance risk assessment committee last year found that women were not always receiving appropriate and timely information on risks of the drug during pregnancy. It must not be used in pregnancy unless there is no suitable alternative treatment.

The HSE’s Rapid Assessment report looked at its potential impact during pregnancy between 1975 and 2015.

It suggests that an estimated 43 to 95 children under the age of 16 today will have experienced a major congenital malformation as a result of Valproate exposure and 349 have some form of neurodevelopmental delay.

Dr Colm Henry, HSE chief clinical officer, told the conference: “A specialist paediatric consultant has been appointed to Our Lady’s Hospital, Crumlin, to support medical diagnosis, and we are working to improve access to genetic testing and diagnosis.

“We have also supported the development of a diagnostic pathway for Valproate syndrome, we are reviewing how community supports for people affected can be improved, and we have also begun the development of women’s health in epilepsy programme.”

Professor Amanda Wood, professor of developmental neuropsychology at Aston University, Birmingham, said: “There remain significant gaps in our knowledge about the longer-term outcomes for children exposed in utero to sodium Valproate and we are committed to ensuring that surveillance of neurodevelopmental effects occurs early for new medicines, including anticonvulsants.”

Peter Murphy, the CEO of Epilepsy Ireland, said he hoped the conference would act as a springboard for implementing the diagnostic and support services that families across the country deserve and urgently require.

Sanofi, the makers of the drug, said that it had provided information and warnings on its use including during pregnancy which was in accordance with regulatory requirements.

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