Lobby Groups Call for Full Review on Use of Epilim

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Calls have been made, by Epilespy Ireland, for a review of 40 cases of birth defects and disabilities that involved the use of the drug Epilim.

Epilim, a drug which the group has urged doctors not to prescribe for new child patients, is currently under review by the European Medicines Agency. Findings of the review are expected to result in new guidelines regarding its use being issue. Epilim is the brand name in Ireland for sodium valproate.

Epilepsy Ireland, and other campaigners, have asked that females being treated with the drug be considered for alternatives medications as a precaution. 1,700 female patients between the ages of 16 and 44, according to official figures released by the Health Service Executive (HSE), were prescribed Epilim during the calendar year 2016.

Issues experienced in Irish births involving the use of the drug include:

  • Foetal malformation
  • Tumours
  • Spina bifida
  • Cerebral palsy
  • Autism
  • Developmental issues
  • Spontaneous abortion

Epilim is currently being implicated in 40 cases of birth defects and disabilities, reported to the Health Products Regulatory Authority (HPRA). Lobby groups are of the opinion that this figure might actually be closer to 400 in the 43 years that the drug has been prescribed for treatment in Ireland.

Additionally it has been reported that, in France, in excess of 4,000 children have been born with malformations since 1967 when the use of the drug on children in the womb began there. Dr Mahmoud Zureik, the scientific director of France’s ANSM, said that reports have shown the possibility of experiencing significant birth defects was, worldwide, four times higher in children born to a woman treated with Valproate (Epilim) for epilepsy, when cross referencde with females who were not prescribed the drug.

Commenting on the use of Epilim, the HPRA said that it has liaised with neurologists, obstetricians, paediatricians, psychiatrists, GPs, family planning clinics, specialist epilepsy nurses, pharmacists and HSE clinical leads on an ongoing basis. Following the completion of the review by the European Medicines Agency is it expected that the HPRA will meet to review the use of Epilim in Ireland by medical professionals.

The Minister for Health, Fine Gael TD for Wicklow, Simon Harris is also due to meet with mothers of children who are believed to have suffered following being prescribed the drug to treat their epilepsy.