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The move comes after The Times highlighted the risks of the drug, which is still routinely prescribed by doctors despite its known side-effects.
The Committee on Safety of Medicines (CSM) said that GPs should no longer give sodium valproate to women who might become pregnant because it carried a greater risk than alternative medicines. A recent study of more than 2,000 pregnant women with epilepsy found that those taking sodium valproate, often prescribed under the brand name Epilim, were almost twice as likely to have babies with birth defects than those on other epilepsy medication.
The study, by doctors at the Royal Victoria Hospital in Belfast, found that women taking the drug had a 7.2 per cent risk of giving birth to babies with spina bifida, heart disease, skeletal and other deformities. Women on another epilepsy medication had that risk reduced to 2.3 per cent.
A group of 20 parents has won legal aid to seek compensation from health authorities, citing negligence. Lawyers believe that many other parents will also make claims. As a result of the concern, the safety committee started an investigation into the drug that has now been published.
It said that women who could become pregnant should not be started on the drug without specialist neurological advise. Women who were already taking the drug should also seek specialist advice about moving to alternative medications. “The risk of congenital malformations in infants born to mothers is approximately two to three times higher than in the general population,” the report concluded.
“An increased incidence has been demonstrated in infants born to mothers with epilepsy taking sodium valproate. Following a review of the data the CSM has advised that women of childbearing potential should not be started on sodium valproate without specialist neurological advise.”
But some doctors have expressed concern that the guidance contradicts advice due out from the National Institute for Clinical Excellence, which recommends sodium valproate as a first-line treatment.
The doctors said that the greater expense of the newer drugs was more than offset by the cost to society of children born with defects. “In women it is much better to start with lamotrigine or Keppra,” Tim Betts, a consultant neuropsychiatrist at the University of Birmingham, told the medical magazine Pulse.
“I know they’re more expensive but the cost of a spina bifida baby is about £2 million.”
A spokeswoman for the charity Epilepsy Action said that it welcomed the decision. “We are pleased that the committee has made this decision, which we have been pressing for for a long time,” she said.
“While we realise that for some women sodium valproate is the most appropriate drug to control their condition, we do believe they should all be assessed by a specialist and their medication reviewed.”
Epilepsy Action says that one in every 130 people in Britain suffers from epilepsy. About 40 per cent are of childbearing age.
The charity runs a helpline on 0808 8005050.
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