Post publication note: this article has been superseded. Valproate medicines are contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met. See Drug Safety Update April 2018 for more information.
In January 2015 we informed you that children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. To further improve awareness of the risks of valproate in pregnancy we are asking that you use the new communication materials below to support discussion of these risks with women of childbearing potential and girls who take valproate. Hard copies are being sent to relevant healthcare professionals from this week.
Later in 2016, the outer packaging for medicines containing valproate will include a warning for women on the risk of adverse pregnancy outcomes.
Summary of risks and precautions
Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases) refs 1-9
Valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.
Valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder.
Carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant.
You must ensure that all female patients are informed of and understand:
the risks associated with valproate during pregnancy;
the need to use effective contraception;
the need for regular review of treatment;
the need to rapidly consult if she is planning a pregnancy or becomes pregnant
For specialists (neurologists, psychiatrists and paediatricians)
We are asking that you use the following communication materials to help manage and minimise the risks outlined above. If you manage specialist care in your organisation, ensure that processes are in place to allow these requirements to be met.
a comprehensive overview of the risks of valproate in females of childbearing potential and during pregnancy,
points to consider and steps to take when deciding to treat women of childbearing potential and girls with valproate.
Whenever you conclude it necessary to treat or continue treating a woman of childbearing potential or girl with valproate, use the checklist to check that you have given her all the necessary information and that she has fully understood it. Add the completed checklist to her medical records as a permanent record of your discussion.
When considering treating a woman of childbearing potential or girl with valproate, give her or her carer the valproate patient guide and ensure that she understands the information it contains.
Valproate is not licensed for treatment of conditions other than epilepsy or bipolar disorder in the UK. However, we are aware that these medicines are sometimes used ‘off-label’ (eg for migraine or chronic pain). If you are considering initiating or continuing such treatment, the same risks and advice in this article apply.
Monitoring effectiveness of risk minimisation
The effectiveness of the above risk minimisation measures will be continuously monitored via prescribing data and evaluation of levels of patient awareness. Results will be communicated as they become available. As with all medicines, we will continue to monitor the safety and efficacy of valproate to assess the need for further regulatory action.