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Parents launch legal action over epilepsy medication

6 October, 2004

Parents who claim
that their children were born with malformations caused by
anti-epileptic drugs (AEDs) taken by the mothers during pregnancy are
launching legal action against the manufacturers of the drugs.

Lawyers
claim that parents faced an 'impossible dilemma' of risking their
health and the health of their children by not taking their AEDs or
taking the medication knowing that posed risks.

Three
cases have been filed at the High Court in London, with around twenty
other cases pending, citing three pharmaceutical companies so far: Sanofi-Synthelabo, CP Pharmaceuticals and Aventis Pharma.

David Body, partner at solicitors Irwin Mitchell,
said the families hoped that if the cases are proved the legal actions
would force the drug companies to take responsibility for the damage
that their products caused:

'We
are hoping to prove that, under the Consumer Protection Act 1987, the
drugs are defective because once these mothers became pregnant, they
were faced with an impossible dilemma.'

'Should
they stop taking anti-convulsant medicine and risk having an epileptic
fit, so risking their unborn child? Or should they continue to take the
drugs knowing that there was a risk of damage to the child from the
drugs?'

The pharmaceutical companies contest the claims by the parents. A statement released by Sanofi-Synthelabo said:

'Anti-epileptic
drugs are crucial to the health of those prescribed them and have
passed stringent medical tests. Sanofi-Synthelabo Ltd has every
sympathy for people born with congenital abnormality, and would advise
women with epilepsy who may become pregnant to speak to their doctor."

CP Pharmaceuticals, in a statement, said:

'It
is acknowledged that there is an increase in the incidence of
congenital abnormalities in children born to mothers with epilepsy who
take anti-epileptic drugs during pregnancy, and this risk is well known
to doctors.

'CP
Pharmaceuticals' Orlept (sodium valproate) was first approved by the
then Department of Health (now the Medicines and Healthcare products
Regulatory Agency) in 1989.

'From
the outset, the product carried a warning that caution should be
exercised in prescribing the drug for use in pregnant women. Over the
years this warning has been updated and strengthened in line with
current medical opinion.'

It is estimated that the case may take up to two years to come to court.