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A pregnant lady imageSeptember 26 2017

Almost a fifth of women with epilepsy (18%) who take sodium valproate are not aware of the potential risks the medicine can pose during pregnancy. The new survey also found that 28% of the women currently taking sodium valproate said they had not been informed of the risks.

 The survey of 2,000 women with epilepsy, aged 16-50, was conducted by Epilepsy Action, the Epilepsy Society and Young Epilepsy, in August and early September, and showed similar results to a similar survey a year ago. In 2016, 20% of respondents said they did not know the risks of taking valproate during pregnancy and 27% of women taking the drug said they had not had a discussion with their healthcare professional about the risks in pregnancy.

The charities are concerned that a valproate toolkit put out by the medicines regulator, the MHRA in February 2016, has not been used sufficiently. The 2017 survey found that “more than two-thirds of women (68%) taking sodium valproate said they have not received any materials from the MHRA toolkit.”

Epilepsy Action said that sodium valproate is linked to an increased risk of birth defects and developmental problems in babies born to mothers taking the medicine. “The risk of physical disabilities in babies born to women taking sodium valproate is estimated to be around 1 in 10 (10%). The risk of developmental problems, which can lead to learning difficulties, is around 2 in 5 (40%).”

Philip Lee, chief executive at Epilepsy Action, said: “It is vital that women with epilepsy get the right information about their care and treatment to ensure a healthy pregnancy and minimise the risks associated with sodium valproate.

“Yet these figures suggest that information is not filtering down to women and that conversations about the potential risks are not always happening. Discussions with a health professional about these risks should be a mandatory part of care for all women with epilepsy so they can make informed choices, ideally before they conceive.”

The survey findings have been published ahead of a public hearing on valproate being conducted by the European Medicines Agency on September 26. The hearing will take place in London, and follows requests by EU member states to review how effective nationally-implemented measures have been in increasing awareness and reducing valproate use appropriately.

The RCGP has issued advice for women taking valproate, advising them “not to panic”.

RCGP Chair, Professor Helen Stokes-Lampard, said: “Patients who are currently taking sodium valproate should not stop without seeking medical advice. Any patient who has particular concerns can ring their GP but there is no need to book an emergency appointment. Most prescriptions are initiated in secondary care but GPs will discuss any concerns at their regular medication reviews with patients.

“However, it is important that patients read warnings on their medicine packets – and really important for women on any long-term medication to tell their GP if they are planning to have a baby. We would also advise patients on long-term medication to use appropriate contraception until they do want to become pregnant.”

Links:
Epilepsy Action announcement
MHRA ‘Toolkit on the risks of valproate medicines in female patients’       
EMA review    
RCGP statement                

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