Sodium Valproate-Epilim Toxicity In Pregnancy

Since approximately the late 1990’s there was increasing evidence of the toxic in utero effects on the fetus of the anti epilepsy drug sodium valproate, commonly marketed as epilim. Initially it was believed that the fetal toxic effects of the drug was confined to neural tube defects (spina bifida), for which folic acid would offer protection. In the years that followed emerging evidence established that the adverse fetal effects of the drug were considerably more widespread and could cause so called "sodium valproate syndrome".

This condition could involve a possible constellation of birth defects and deformities in the baby affecting facial features, eyes, ears, lips, hands, fingers and toes.

By 2008 it became clearer that the drug might also be responsible for causing cognitive difficulties, mental retardation, global developmental delay and/or autism in the affected child.

Over the years the warnings given by the drug manufacturers in the product information leaflet have become ever more stark and have counselled great caution in its use for treatment of epilepsy in women of child bearing age. Basically, the recommendation and proper medical advice for the past decade or more has been to either temporarily stop using the drug during pregnancy, reduce the dosage during pregnancy and/or, if possible, switch to an alternative medication.

in 2010 Michael Boylan (when head of medical negligence department at his previous firm) successfully brought the first ever legal action in this country for a child who was wrongfully exposed to the toxic effects of the drug during pregnancy and who suffered damage as a result (see case report on McGillin v Casey and ors)
Michael Boylan is currently acting for a number of woman and children who have suffered birth defects as a consequence of being negligently exposed to the effects of the drug. If you require any advice on this issue please contact him at michael@michaelboylan.com

 

Recent cases of note

  • High Court approves disability settlement over misuse of epilim-sodium valproate drug in pregnancy