Toolkit on the risks of Sodium Valproate

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.
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. There is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).

    Current 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.

From February a Sodium Valproate Toolkit was launched to inform women of childbearing age about the risks Valproate poses to an unborn baby. The Toolkit consists of :

Checklist

Patient Card : http://www.medicines.org.uk/emc/RMM.422.pdf

Brochure for Patients http://www.medicines.org.uk/emc/RMM.421.pdf

Brochure for Health Care Professionals

INFACT have been heavily involved with the construction of the Toolkit and very much so welcome these materials, however for the Toolkit to be effective and reach every single woman prescribed Valproate we feel this should be made a mandatory action.