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EU Strengthens Warnings on Valproate

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Demetria Ratchford3 years ago

The European Union has ordered Valproate carry new warnings due to concerns that the drug can lead to congenital malformations in newborns.

Valproate Warnings

Valproate has been known to cause congenital malformations and developmental problems in children who are exposed to the drug in utero.

Valproate is mainly used to treat epilepsy and bipolar disorder, and to treat migraines. Recently, however, the CMDh, a European regulatory body representing EU member states, has decided to strengthened the warning on the anticonvulsant valproate, in an effort to restrict its use in women of childbearing age.

EU clinicians are advised to not prescribe the drug to women or girls who can become pregnant unless other treatments are ineffective.

CMDh also notes that women and girls prescribed valproate should not stop taking their medication without consulting their doctor, in order to ensure the safety of the unborn child. Doctors also should not prescribe valproate for migraine prevention for women who are not on effective contraception.

Basis of New Recommendations

According to Medscape, the recommendations from the CMDh are based on review of recent studies.

The studies show that 30% to 40% of preschool-aged children exposed to valproate in the womb develop problems such as delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.


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