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Epilepsy drug's safety reviewed over pregnancy risk

Women whose children have been harmed by the epilepsy drug sodium valproate will give evidence to a European-wide safety review in London next week. The European Medicines Agency will examine whether warnings about risks to unborn babies are strong enough.About 20,000 babies in the UK alone have been left with disabilities since valproate was introduced in the 1970s.The medicines regulator said warnings had been updated as more information had become available.Many women whose babies were affected say nobody warned them of the extent of the dangers. Valproate is an effective treatment for epilepsy, bipolar disorders and migraine - and doctors prescribe it because it is the best option for some women.Instructions for doctors - and, more recently, patient leaflets - say valproate should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the risks.Babies exposed to valproate medicines in the womb have a 10% chance of developing physical abnormalities. Julie Marjot, from Norfolk, says it wasn't until her last child was born that she was told the pills she took had harmed three of her four children."As time went by and we had more children, we saw more paediatricians, we saw GPs, we saw midwives, we saw all of these healthcare professionals. "Sanofi will reinforce the fact that sodium valproate is an important molecule that epileptic women continue to rely on, even today, to control seizures, to avoid a potentially fatal seizure during their lifetime, including during pregnancy."It said doctors needed a range of therapeutic options to help women with epilepsy through pregnancy.

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