PRAC recommends strengthening the restrictions on the use of valproate in women and girls

Women to be better informed of the risks of valproate use during pregnancy
The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended
strengthening the restrictions on the use of valproate medicines due to the risk of malformations and
developmental problems in children exposed to valproate in the womb.
Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are
pregnant or who can become pregnant unless other treatments are ineffective or not tolerated. Women
for whom valproate is the only option after trying other treatments, should use effective contraception
and treatment should be started and supervised by a doctor experienced in treating these conditions.
Women who have been prescribed valproate should not stop taking their medicine without first
consulting their doctor.
In countries where valproate medicines are authorised for the prevention of migraine, women must not
use valproate for preventing migraine when they are pregnant. Pregnancy should be excluded before
starting treatment for migraine, and women should use effective contraception.
The PRAC also recommended that doctors who prescribe valproate provide women with full information
to ensure understanding of the risks and to support their decisions.
These recommendations follow a review of available data on the effects of valproate exposure during
pregnancy. During the review the PRAC also consulted representatives of patients and families who
have been affected as well as a group of experts and specialists. While valproate remains an option for
patients where other treatments have failed or are not tolerated, the Committee concluded that
women and healthcare professionals need to be better informed about the risks of valproate exposure
in the womb and of the need for effective contraception.
Recent studies have shown a risk of developmental problems of up to 30 to 40% in pre-school children
exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty
with speech and language and lower intellectual ability.
In addition, data show that children exposed to valproate in the womb are at an approximately 11%
risk of malformations at birth (such as neural tube defects and cleft palate) compared to a 2 to 3% risk
for children in the general population. Available data also show that children exposed to valproate in
the womb are at increased risk of autistic spectrum disorder (around 3 times higher than in the general



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