Acido valproico se asocia significativamente con al menos 6 malformaciones congénitas

Publicado el 20.07.2010

Estudio recientemente publicado en el NEJM, derivado del EUROCAT revela que existe una asociación entre acido valproico y malformaciones congénitas fetales, aún cuando se administra en monodosis para el tratamiento de la epilepsia. Las malformaciones implicadas son la espina bífida, defectos septales cardíacos, fisura labiopalatina, hipospadia, polidactilia y craneosinostosis.

Janneke Jentink, M.Sc., Maria A. Loane, M.Sc., Helen Dolk, Dr.P.H.,
Ingeborg Barisic, Dr.P.H., Ester Garne, M.D., Joan K. Morris, Ph.D.,
Lolkje T.W. de Jong-van den Berg, Ph.D., for the EUROCAT Antiepileptic
Study Working Group

ABSTRACT

Background The use of valproic acid in the first trimester of pregnancy is associated with an increased risk of spina bifida, but data on the risks of other congenital malformations are limited.

Methods We first combined data from
eight published cohort studies (1565 pregnancies in which
the women were exposed to valproic acid, among which 118
major malformations were observed) and identified 14
malformations that were significantly more common among the
offspring of women who had received valproic acid during the
first trimester. We then assessed the associations between
use of valproic acid during the first trimester and these 14
malformations by performing a case–control study with the use
of the European Surveillance of Congenital Anomalies (EUROCAT)
antiepileptic-study database, which is derived from population-based
congenital-anomaly registries. Registrations (i.e.,
pregnancy outcomes with malformations included in EUROCAT) with
any of these 14 malformations were compared with two control groups,
one consisting of infants with malformations not previously linked
to valproic acid use (control group 1), and one consisting of
infants with chromosomal abnormalities (control group 2). The
data set included 98,075 live births, stillbirths, or terminations with malformations among 3.8 million births in 14 European
countries from 1995 through 2005.

Results Exposure to valproic acid
monotherapy was recorded for a total of 180 registrations,
with 122 registrations in the case group, 45 in control group
1, and 13 in control group 2. As compared with no use of an
antiepileptic drug during the first trimester (control group
1), use of valproic acid monotherapy was associated with
significantly increased risks for 6 of the 14 malformations
under consideration; the adjusted odds ratios were as
follows: spina bifida, 12.7 (95% confidence interval [CI],
7.7 to 20.7); atrial septal defect, 2.5 (95% CI, 1.4 to 4.4);
cleft palate, 5.2 (95% CI, 2.8 to 9.9); hypospadias, 4.8 (95%
CI, 2.9 to 8.1); polydactyly, 2.2 (95% CI, 1.0 to 4.5); and
craniosynostosis, 6.8 (95% CI, 1.8 to 18.8). Results for exposure
to valproic acid were similar to results for exposure to
other antiepileptic drugs.

Conclusions The use of valproic
acid monotherapy in the first trimester was associated with
significantly increased risks of several congenital
malformations, as compared with no use of antiepileptic drugs
or with use of other antiepileptic drugs.

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