EU Strengthens Warnings on Valproate Use in Women

Caroline Cassels

Disclosures

November 21, 2014

The CMDh, a European regulatory body representing EU member states, has moved to strengthen warnings on the anticonvulsant valproate (Depacon, AbbVie Inc) in a bid to restrict its use in women of childbearing age.

Known to cause congenital malformations and developmental problems in children who are exposed to the drug in utero, valproate is used to treat epilepsy and bipolar disorder and to prevent migraine.

EU clinicians are being advised not to prescribe the drug to women or girls who can become pregnant unless other treatments are ineffective or not tolerated. In those for whom valproate is the only treatment option, clinicians need to advise patients about the importance of effective contraception, and treatment should be initiated and supervized by a physician experienced in the treatment of epilepsy and bipolar disorder.

However, in a press release, the CMDh also notes that women and girls who have been prescribed valproate should not stop taking their medication without consulting their doctor, because doing so could result in harm to themselves or to an unborn child.

In countries where valproate is also authorized for the prevention of migraine, valproate must not be used for this purpose in pregnant women, and doctors should exclude pregnancy before starting preventive treatment for migraine. Doctors must not prescribe valproate for migraine prevention for women who are not on effective contraception.

These recommendations are based on a review of recent studies showing developmental problems in up to 30% to 40% of preschool-aged children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language, and lower intellectual ability.

"The warnings aim to ensure that patients are aware of the risks and that they take valproate only when clearly necessary," the agency notes.

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