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Women need to be made aware of the risks of taking valproate during pregnancy, says Jane Bass, senior pharmacist, women’s services, Guy’s and St Thomas’ NHS Foundation Trust

In November 2013, the MHRA published a Drug Safety Update reminding healthcare professionals that sodium valproate should not be used in pregnancy “unless there is no effective alternative”. Patient information leaflets now state that the babies of women who take valproate in pregnancy may display slow development or autistic disorders.

Ongoing review

A European Medicines Agency (EMA) risk/benefit review of valproate use in pregnancy is ongoing. Initial discussions have included the need for healthcare professionals and patients to be aware of the updated pregnancy advice for valproate. However the QOF requiring GPs to monitor the number of women of child-bearing age taking anti-epileptic drugs who have received information and counselling on contraception, conception and pregnancy in the previous 12 months has been withdrawn. It is therefore more important than ever that pharmacists advise women when they are picking up their prescriptions for valproate:

• To read the patient information leaflet provided with the medication as this will have been updated. Many women have been taking valproate for several years so probably no longer read the leaflet and remain unaware of the revised risks.

• To speak to their GP or specialist about whether valproate is still the most appropriate drug for them if they wish to become pregnant. Women should be advised not to stop valproate suddenly as there is a risk of their condition worsening if it is stopped in an uncontrolled way (e.g. relapse of bipolar disorder). This empowers patients to ask their GP or specialist to talk through the risk/benefit balance for them as an individual.

• To get a prescription from their GP for 5mg folic acid daily, and to start taking it as soon as they stop contraception or are planning a pregnancy.This needs to be taken around the time of conception and for at least the first 12 weeks of pregnancy. OTC pregnancy vitamin preparations do not contain enough folic acid to reduce the increased risk of physical malformations in these babies. There may also be neurodevelopmental benefits from taking folic acid periconceptually.

A vitamin D supplement should be advised for all pregnant women (10mcg daily)but particularly for those on valproate.

Sign up

Women with epilepsy should also be encouraged to sign up to the UK Pregnancy and Epilepsy Register early in pregnancy (www.epilepsyandpregnancy.co.uk) so that information from their pregnancy can be added to that from more than 10,000 others. This will help researchers develop the best advice for women considering pregnancy.