The Royal Pharmaceutical Society has come out in support of new restrictions on the prescribing of an epilepsy drug that can harm the health and development of unborn children, saying the measures will help women “make informed choices about their health and parenting options”.

The Medicines and Healthcare products Regulatory Agency recently announced new measures which mean doctors will only be able to prescribe sodium valproate to female patients of childbearing potential who are put on a Pregnancy Prevention Programme, which involves discussing the risks with a doctor and being informed of the importance of using contraception while using the drug.

While health bodies have welcomed the decision to limit the prescribing of valproate, currently the third most prescribed epilepsy medication, they have voiced a consensus that no one currently taking it should cease to do so without first seeking expert medical advice.

‘A very real risk’

The MHRA says that when valproate is taken during pregnancy, up to four in 10 babies are at risk of developmental disorders, and around one in 10 are at risk of birth defects. It is thought that around 20,000 UK children have been born with birth defects caused by valproate since it was introduced in the 1970s.

Dr June Raine, director of MHRA’s vigilance and risk management of medicines division commented on the new policy: “Patient safety is our highest priority. 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.” 

RPS: women must get the right information

RPS president Ash Soni said: “The RPS fully supports these new measures implemented today by the MHRA to ensure women understand the risks of taking sodium valproate during pregnancy. They must get the right information from health professionals in order to make informed choices about their health and parenting options.

“Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional. Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.”

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