Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.
The risk of developmental disorders is up to 4 in 10 and the risk of birth defects is approximately 1 in 10. The risk for autism, ASD and ADHD is higher for children exposed in-utero.
MHRA has worked with industry, healthcare professionals and patient groups on a toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.
In women who take valproate while pregnant, around 1 in 10 babies will have a birth defect.
Birth defects seen when mothers take valproate during pregnancy include:
- spina bifida (where the bones of the spine do not develop properly)
- facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
- malformations of the limbs, heart, kidney, urinary tract and sexual organs.
In women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems. The long-term effects are not known.
The effects on development can include:
- being late in learning to walk and talk
- lower intelligence than other children of the same age
poor speech and language skills
- memory problems.
Children exposed to valproate in the womb are more likely to have autism or autistic spectrum disorders (ASD). There is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).
MHRA February 2016 advice
Valproate should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated. Women of childbearing potential must use effective contraception during treatment.
No-one should stop taking valproate without discussing it first with their doctor and the benefits of valproate treatment must be carefully balanced against the risks.
If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.
For Healthcare Professionals
Toolkit on the risks of valproate medicines in female patients, Medicines and Healthcare products Regulatory Agency, 8 February 2016.