Epilim (sodium valproate)

Women on epilepsy drugs sue over birth defects
By Linda Jackson

Telegraph Dec 1996 http://www.telegraph.co.uk/

SEVENTY women with epilepsy are taking legal action against various British health authorities after giving birth to children with abnormalities linked to anti-convulsant drugs.

A legal researcher involved in the cases described the action as "bigger than Thalidomide". Up to 500,000 people in the UK have epilepsy. The first case, involving a woman who gave birth to a child with spina bifida after taking sodium valproate during pregnancy, will be launched early next year. Another case, to be heard later in the year, involves a woman who had two severely disabled daughters after taking the same drug.

Lawyers say doctors failed to alert the women to the full extent of the risks to the unborn child of sodium valproate and other anti-convulsants. This is despite well-documented research highlighting the increased risk of birth defects for women taking anti-convulsants.

The British Epilepsy Assocation is launching a campaign to raise awareness among the medical profession of the risks involved.

In the first case, Sharon Walker, 29, of Wallasey, Merseyside, learned that her unborn child had spina bifida when she was eight and half months pregnant. She was taking large doses of the anti-convulsant drugs Tegretol and sodium valproate, sold as Epilim.

She said she knew nothing of the increased risk of spina bifida. Women taking sodium valproate are 20 times more likely to have a child with the condition. She is suing Wirral Health Authority for more than 500,000.

The second case involves Christine Stafford, 30, who took Epilim during two pregnancies. Her two daughters - Aimee, 10, and Charlotte, nine - are severely disabled. She says she was told by doctors that there was no risk from the drug. She later found she had been misdiagnosed as having epilepsy and should not have been given the drugs in the first place.

Nina Rowland, a partner with Liverpool-based solicitors Goldsmith Williams, which is handling the lawsuits, said most involved sodium valproate, which is commonly prescribed.

Fourteen further cases involving children born with spina bifida are also due to be heard next year. The condition involves partial paralysis, where the vertebrae fail to develop fully, leaving part of the spinal cord exposed. All the mothers were taking sodium valproate.

Most of the remaining cases involved disabilities known as foetal valproate syndrome. This is typified by a wide-bridged nose, wide forehead, mental retardation and difficulties with movement. Two babies who were born with congenital heart defects, also linked to the drug, later died.

Miss Rowland said information sheets on possible side effects were contained in drugs packets, but doctors failed to tell the women of all the risks involved. Dr Ley Sanders, a consultant at the National Hospital for Neurology and Nervous Diseases in London, said the risks of birth defects from anti-convulsants were "well-known and recognised".

"It is important that women are told of the possible effects. However, the overall risk is small and it might be safer for people to stay on the drugs than risk a seizure during pregnancy which could harm the baby."

Len Pearse-Butler, chief executive of Wirral Health Authority, said he could not comment until he had received a claim.