This safety statement is being issued to alert stakeholders to the revised guidance on the use of valproic acid (sodium valproate) for the treatment of epilepsy and bipolar disorder in women and girls of childbearing potential contained in addenda to the mhGAP intervention guide (mhGAP-IG) and mhGAP humanitarian intervention guide (mhGAP-HIG). The addenda have been issued in advance of an update to the mhGAP guideline for non-specialist health-care providers which is due to be released later this year, and was discussed at the meeting of the WHO Advisory Committee for the Safety of Medicinal products (ACSoMP) on 14 December 2022 [2022 December ACSoMP recommendations]. A safety statement has also been added to the Essential Medicines List (EML).
Prescription of valproic acid (sodium valproate) for women and girls of childbearing potential:
Valproic acid (sodium valproate) should not be prescribed to women and girls of childbearing potential because of the high risk of birth defects and developmental disorders in children exposed to valproic acid (sodium valproate) in the womb. In women and girls of childbearing potential, lamotrigine or levetiracetam should be offered as first line monotherapy for both generalized onset seizures and focal onset seizures.
For women and girls of childbearing potential currently prescribed valproic acid (sodium valproate):
Advice should be provided on use of effective contraception, without interruption, during the entire duration of treatment. Information must be provided on risks associated with valproic acid (sodium valproate) use during pregnancy, pregnancy prevention and refer for contraceptive advice if they are not using effective contraception.
Individual circumstances should be evaluated in each case when choosing the contraception method and involving the woman in shared decision making.
If a woman is planning to become pregnant, a person trained in the management of epilepsy/bipolar disorder in pregnant women should consider alternative treatment options. Women should be informed to consult their physician as soon as they are planning pregnancy and the need to urgently consult their physician in case of pregnancy.
Every effort should be made to switch to appropriate alternative treatment prior to conception. If switching is not possible, the woman should receive further counselling regarding the risks of valproic acid (sodium valproate) for the unborn child to support her informed decision-making.
A specialist should periodically review whether valproic acid (sodium valproate) is the most suitable treatment for the person.
