Background: The frequency of major malformations, growth retardation, and h
ypoplasia of the midface and fingers, known as anticonvulsant embryopathy,
is increased in infants exposed to anticonvulsant drugs in utero. However,
whether the abnormalities are caused by the maternal epilepsy itself or by
exposure to anticonvulsant drugs is not known.
Methods: We screened 128,049 pregnant women at delivery to identify three g
roups of infants: those exposed to anticonvulsant drugs, those unexposed to
anticonvulsant drugs but with a maternal history of seizures, and those un
exposed to anticonvulsant drugs with no maternal history of seizures (contr
ol group). The infants were examined systematically for the presence of maj
or malformations, signs of hypoplasia of the midface and fingers, microceph
aly, and small body size.
Results: The combined frequency of anticonvulsant embryopathy was higher in
223 infants exposed to one anticonvulsant drug than in 508 control infants
(20.6 percent vs. 8.5 percent; odds ratio, 2.8; 95 percent confidence inte
rval, 1.1 to 9.7). The frequency was also higher in 93 infants exposed to t
wo or more anticonvulsant drugs than in the controls (28.0 percent vs. 8.5
percent; odds ratio, 4.2; 95 percent confidence interval, 1.1 to 5.1). The
98 infants whose mothers had a history of epilepsy but took no anticonvulsa
nt drugs during the pregnancy did not have a higher frequency of those abno
rmalities than the control infants.
Conclusions: A distinctive pattern of physical abnormalities in infants of
mothers with epilepsy is associated with the use of anticonvulsant drugs du
ring pregnancy, rather than with epilepsy itself. (N Engl J Med 2001;344:11
32-8.) Copyright (C) 2001 Massachusetts Medical Society.