Medicine & Law: Epilepsy drug

Nearly everyone in Ireland over a certain age has heard of the drug Thalidomide. It was given to pregnant women to eliminate morning sickness but led to unwanted changes in the foetus some of whom were born without one or several limbs.

 There was a certain element of déjà vu when reports in the Irish Medical Times recently announced an inquiry into another drug which pregnant women were prescribed to control their epilepsy.

The drug, sodium valproate, purchased in Ireland under the trade name Epilim, was more than useful in controlling their epileptic fits but posed a risk of congenital malformation to any children exposed to the drug in the womb. It also brought about serious development disorders in other children equally exposed.

The government appointed barrister Brid O’Flaherty, a medical negligence practitioner, to chair an inquiry into the use of the drug among pregnant women in Ireland. Similar enquiries have been set up in the UK and elsewhere.

The chairwoman will review the way the drug which has been regularly prescribed in Ireland, as well as, perhaps more importantly, the timeline of scientific knowledge about the product’s disastrous effects on foetal development in the womb. Also in her brief is an examination of safety concerns around the treatment and to make recommendations as necessary.

The statistics do not make for pleasant reading. Between 1975 and 2015 350 children experienced congenital malformation when their mothers were prescribed the drug during pregnancy. On an even more dramatic note, in January last GP were warned about the possible side-effects arising from the use of the drug by men during the months leading up to conception.

Studies and research undertaken indicated an increased risk of a range of neurodevelopmental disorders such as delayed learning, ADHD and autism in children, whose fathers were treated with the drug Epilim during the months before conception.

It is to be hoped that the issues around Epilim will be sorted in the not too distant future compared with the long drawn out legal battles surrounding Thalidomide over the last 50 years or so.