english.prescrire.org > Spotlight > Archives : 2018 > Avoid pregnancy during treatment with valproic acid or its derivatives

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Avoid pregnancy during treatment with valproic acid or its derivatives

New measures have been taken in the European Union to prevent the exposure of fetuses to valproic acid and its derivatives.

Valproic acid and its derivatives, respectively authorised in certain types of epilepsy and bipolar disorders, are teratogenic: they expose the unborn child to congenital malformations and serious psychomotor developmental disorders in childhood. 

Since 2014, preventive measures have been put in place in the EU and France: the recommendation to use valproic acid in girls and pregnant women or women of childbearing age only in the absence of a therapeutic alternative; improved information on the need for effective contraception; initial prescription restricted to paediatricians, neurologists and psychiatrists, with the obligation for both the prescriber and the patient to sign a care agreement informing on the risks in case of pregnancy. Some of these measures are the result of campaigning by APESAC (Association of Parents of Children with Anticonvulsant Syndrome).

In mid-2018, these measures were reinforced at the EU level. Valproic acid is now contraindicated in epilepsy in pregnant women, except in exceptional circumstances. It is also contraindicated in women of childbearing age, unless all the conditions of the "pregnancy prevention programme" are met: pregnancy tests before and during treatment, consultation with the prescriber to discuss treatment options when pregnancy is desired.

In France, by the end of 2018, the only pictogram shown on valproic acid packets will represent a barred red circle with the words "PREGNANCY = PROHIBITED" on tablet blister packs, sachets and vials.

©Prescrire 1 December 2018

"Valproic acid and its derivatives: pregnancy prevention measures stepped up in the EU" Prescrire Int 2018; 27 (199): 293-294. (Pdf, subscribers only).

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See also:

Valproic acid and
pregnancy: assessment of
malformations in France
Prescrire Int 2017;
26 (188): 294.
Pdf, free

Valproic acid and pregnancy
(December 2017)
Free

Pregnancy: drugs to avoid
(August 2013)
Free

Valproic acid: long-term effects
on children exposed in utero
(January 2010)
Free