Babies exposed to valproate in the womb are at high risk of serious complications.
NICE guidance has been updated to align with the advice provided on the use of valproate by the Medicines and Healthcare products Regulatory Agency (MHRA). Valproate must not be used by any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.
Valproate is licensed for use in treating bipolar disorder and epilepsy. It is also used outside of its product licence (off-label use) for treating neuropathic pain, migraine, depression and dementia.
If valproate is taken during pregnancy, up to 4 in 10 babies may have developmental problems and 1 in 10 may have a birth defect, according to data from the MHRA.
Total prescribing of valproate for women or girls aged 14 to 45 in England has reduced in recent years, as shown in data from the NHS Business Services Authority. Though this trend is positive, some women or girls who can have children continue to take it, which suggests that more can be done to reduce the risk.
Fewer women or girls aged 14 to 45 are being prescribed valproate
Number of women or girls, aged 14 to 45, receiving a prescription for sodium valproate
Between January to March 2019, the proportion of all patients receiving prescriptions for sodium valproate who are women or girls aged 14 to 45 ranged from 6% to 13% across CCGs. This suggests there is wide variation and there may be room for improvement in many areas.
There is CCG variation in the proportion of all patients receiving prescriptions for sodium valproate who are women or girls aged 14 to 45 (Jan to Mar 2019)
The proportion of all patients receiving prescriptions for sodium valproate who are women or girls aged 14 to 45 by CCG
To further address this risk, we have published a summary sheet which brings together existing information and advice on safe prescribing from other sources (for example, MHRA safety alerts, BNF information, summary of products data and information from the Driver and Vehicle Licensing Agency) with NICE’s existing guideline recommendations, to produce easy to access, practical recommendations supported by a visual summary.