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Women and girls must be warned of the risks associated with valproate

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Women and girls must be adequately informed about the risks of taking valproate medication, prescribed for bipolar disorder and epilepsy, the MHRA has warned.

Valproate is known to be damaging to fetal development causing babies to have birth defects. However, a European review in 2014 showed that of the 35,000 women prescribed valproate during the course of the review, 375 became pregnant. It found that approximately 40 per cent of children born to women who take valproate during pregnancy may have developmental disorders or other defects.

The MHRA has produced information booklets for healthcare professionals and patients as an educational tool. The warnings on the leaflet inside the packaging has also been strenghtened to increase awareness of the risks to unborn children.

Dr June Raine, director of MHRA's vigilance and risk management of medicines division, said:'If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment,' she added.

'We want to ensure that medical professionals inform women and girls of the latest information about the risks of developmental disorders in children exposed to valproate during pregnancy, in addition to the already well-known risks of birth defects.'

NICE is currently reassessing the use of valproate as part of its guidelines on epilepsy and bipolar disorder.

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