Women remain uninformed of the risks of sodium valproate

In a recent survey, conducted by the three leading epilepsy charities – Epilepsy Action, Epilepsy Society and Young Epilepsy – more than a quarter (28%) of women taking sodium valproate said that they had not received any information on the harm it could do to an unborn child.  

The drug is used to treat epilepsy, migraine and bipolar disorder. However, in babies whose mothers are given the drug during pregnancy there is a 10% increased risk that the unborn child will develop physical birth defects, and a 40% chance that they will develop autism, low IQ and/or learning difficulties.

The survey used the responses from 2000 women with epilepsy and found almost 1 in 5 women (18%) with epilepsy taking sodium valproate had no knowledge of the harm it could do to their child if they became pregnant. These results are despite efforts by the Medicines and Healthcare products Regulatory Agency to raise greater awareness of the dangers of sodium valproate by releasing a toolkit in February 2016 to aid health professionals in discussing the risks with female patients prescribed the drug. The toolkit included booklets for pharmacists and patients, along with a checklist of discussion points, however, survey results showed that more than two thirds (68%) of women prescribed sodium valproate still had not received any of the toolkit materials.

Susan Cole, 53, whose daughter has learning difficulties, said to the BBC: “There are also the miscarriages and stillbirths. We don’t know how many of them there have been. But there’s been no help and no investigation into what went wrong – why were there not more warnings, why have doctors not been clearer about the risks?”

It is estimated by campaigners that up to 20 000 children in the UK have been harmed by the drug since it was introduced in the 1970s. However, for some women it remains the only medication that effectively controls their epilepsy.

The charities Epilepsy Action, Epilepsy Society and Young Epilepsy are now leading calls on the government to stop the renewal of prescriptions of sodium valproate after a period of 12 months in women of childbearing age without a face-to-face consultation with a health professional. The consultation will be used to properly inform women of the risks to their child by taking the drug during pregnancy.

The European Medicines Agency (EMA) risk assessment committee is currently in London reviewing testimonies from families affected by sodium valproate, alongside experts and the drug’s maker Sanofi, which produces it under the brand name Epilim. The EMA will then make a decision on what extra measures should be taken to protect women using sodium valproate.

In France, the government has set aside funds to support the legal action of 1200 families preparing to sue Sanofi for failing to provide adequate information on Epilim. In the UK, government support was withdrawn in 2010 for a similar legal dispute initiated against Sanofi by families in England and Wales.

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