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Anti-epilepsy drug restricted in bid to reduce risk of birth defects in children

About 20,000 UK children are thought to have been harmed by valproate medicines since the Seventies because their mothers took them during pregnancy: PA Wire/PA Images
About 20,000 UK children are thought to have been harmed by valproate medicines since the Seventies because their mothers took them during pregnancy: PA Wire/PA Images

New restrictions on an anti-epilepsy drug were introduced today in a bid to reduce to an “absolute minimum” the risk of it causing birth defects in children.

About 20,000 UK children are thought to have been harmed by valproate medicines since the Seventies because their mothers took them during pregnancy.

It is the third most prescribed anti-epilepsy medication, but carries a 10 per cent risk of physical abnormalities and up to a 40 per cent risk of causing autism, low IQ or learning disabilities.

A six-year campaign today resulted in the Medicines and Healthcare products Regulatory Agency (MHRA) changing the licence, banning it from being prescribed to women or girls of childbearing age unless they are enrolled on a “pregnancy prevention programme”.

This requires them to sign a form annually to indicate they are aware of the risks and the need to comply with contraception advice.

Fertility experts today warned that valproate drugs — such as Epilim, Depakote and generic brands — can interfere with standard contraceptive pills and urged women to seek longer-acting solutions, such as the coil, implants or sterilisation.

Valproate is also prescribed for bipolar disorder and migraine. Surveys have shown that there is low awareness of the risks to the unborn child.

Neurologists have warned that untreated epilepsy also presents a serious risk to women and unborn children. People taking valproate were today warned not to stop taking it without seeking medical advice.

Pack sizes will be reduced to encourage monthly prescribing and stronger warnings will be used on packaging.

Dr June Raine, MHRA director of vigilance and risk management of medicines, said: “We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.”

“It has taken many years to achieve these simple, straightforward and inexpensive healthcare improvements that will prevent babies being born with avoidable disabilities''

Clare Pelham, chief executive of Epilepsy Society, said: “It has taken many years to achieve these simple, straightforward and inexpensive healthcare improvements that will prevent babies being born with avoidable disabilities. All credit to the brave women who have campaigned for decades.”

Health minister Lord O’Shaughnessy said: “The focus will now be on explaining these changes to GPs and clinicians so they in turn can advise patients.”

Carol Long, chief executive of Young Epilepsy, said: “Sodium valproate can provide life-changing support for many young people with epilepsy. The percentage of women who do not know the risks of taking the drug during pregnancy is far too high.”