201801.20
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European Medicines Agency Reviewing Use of Epilim

The European Medicines Agency (EMA) is currently reviewing the use of Epilim to treat cases of Epilepsy following a number of report that have linked it to instances of birth defects and disability.

Epilim, a drug which Epilepsy Ireland 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. Epilim is the brand name in Ireland for sodium valproate,

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

Issues experienced by Irish using the drug include, along with some reports of spontaneous abortion:

  • Foetal malformation
  • Tumours
  • Spina bifida
  • Cerebral palsy
  • Autisc illnesses
  • Issues with development

Report in France state over 4,000 infants were born with malformations since 1967, when the use of the drug on children in the womb began in that country. Dr Mahmoud Zureik, the scientific director of France’s ANSM, remarked that the results showed that the potential for experiencing significant birth defects was globally four times greater in children born to a woman suffering from epilepsy being  treated with Valproate (Epilim), when compared with woman females who were not treated with the drug.

The Fine Gael Minister for Health Simon Harris is due to meet with Irish mothers of children who are thought to have suffered following being prescribed the drug to treat their own epilepsy.

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 belief that this figure might actually be closer to 400 in the 43 years that the drug has been prescribed for treatment of epilepsy in expectant mothers in Ireland.

Once the EMA review findings have been released it is likely that the HPRA will meet to review the use of Epilim in Ireland by doctors.