Baroness Masham of Ilton – 2014 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Baroness Masham of Ilton on 2014-06-11.

To ask Her Majesty’s Government what information is currently given to female patients concerning the potential problems of taking valproate in pregnancy; and how that information reflects the guidelines established by the National Institute for Health and Care Excellence on those issues.

Earl Howe

The Patient Information Leaflet (PIL) that accompanies the medicine is intended to supplement the information provided by the prescriber. The PIL for Epilim (a brand of valproate for the treatment of epilepsy) states that women who are pregnant or of childbearing age should not take valproate unless explicitly advised by their doctor and provides information on birth defects, impaired development and other problems which may occur in babies born to mothers who take valproate during pregnancy. The PILs for other brands of valproate used in the treatment of epilepsy and to control mania in bipolar disorder contain similar warnings. The warnings in the information for healthcare professionals, the Summary of Product Characteristics (SPC) and the PIL are currently the subject of a Europe–wide review which was prompted by new data on the risk of developmental disorders in children born to mothers who took valproate during pregnancy.

The National Institute for Health and Care Excellence (NICE) clinical guideline on epilepsy made the following recommendation as a key priority for implementation: "Women and girls with epilepsy and their partners, as appropriate, must be given accurate information and counselling about contraception, conception, pregnancy, caring for children, breastfeeding and menopause." NICE’s clinical guideline on bipolar disorder recommends that valproate should not routinely be prescribed to pregnant women with bipolar disorder.