Mothers sue over Epilepsy drug

Women who took an epilepsy medication during pregnancy are suing for damages, claiming the drug harmed their children.

They have foetal anti-convulsant syndrome (FACS), which can involve physical and learning difficulties.

Lawyers argue the women had a choice between taking the drug and risking side effects or not taking the drug and risking seizures.

Sanofi-Synthelabo, who market the drug have said that the risks associated with the drug are and have always been well known to doctors.

The company say there could be a range of causes for the congenital abnormalities, not just exposure to anti epileptic drugs during pregnancy.

The case does not accuse the companies of negligence rather the case is being brought under consumer protection laws introduced after the thalidomide disgrace, to give patients a way of claiming compensation, even if negligence on the part of the drug company could not be proved.

The solicitor in the case says that women with epilepsy hoping to become pregnant were faced with an "impossible dilemma. They have to make a choice between not taking the drug during pregnancy to protect the child, or alternatively running the risk of the syndrome by taking the drug".

It is accepted that the drug, marketed under the trade names Epilim or Orlept, is an effective treatment for epilepsy.

According to the BBC there are three cases filed at the High Court, but at least twenty more are pending, and there are hundreds of children with FACS who may be affected, although the actual figure is unknown.

A Professor of neurology at the University of Liverpool was quoted as saying for each individual woman there is a balance of risks between reducing the risk from drugs, but also reducing the risk that seizures carry to pregnancy, it is quite simply a question of choosing the right drug for the right woman with epilepsy.

Drug such as sodium valproate were linked with a 10% risk of foetal abnormalities if taken during pregnancy, compared to a four to five per cent risk with other anti-epileptic drugs, and a two to three per cent risk in babies generally.

In a statement, Sanofi-Synthelabo, who market sodium valproate under the trade name Epilim, said "Anti-epileptic drugs are crucial to the health of those prescribed them and have passed stringent medical tests".

It acknowledged an increased incidence of congenital abnormalities in children born to mothers with epilepsy who take anti-epileptic drugs during pregnancy, and said this risk was well known to doctors.

"Sanofi Synthelabo Ltd has at all times acted responsibly in relation to its marketing of anti-epileptic drugs", it said.

Female First