Some studies suggest that the use of certain antiepileptic medications such as valproic acid (Depacon / Depakene / Depakote) in the first trimester is associated with an increased risk of spina bifida. Limited information is available on the risks of other congenital malformations. A study done by a team from the Department of Pharmacoepidemiology and Pharmacoeconomics, within Division of Pharmacy at The University of Groningen, in Groningen, The Netherlands, titled “Valproic Acid Monotherapy in Pregnancy and Major Congenital Malformations”, combined data from 8 studies and identified 14 types of malformations associated in offspring of women who received valproic acid during their first trimester. Out of 1,565 pregnancies exposed to valproic acid, 118 major malformations were seen.
The 14 kinds of malformations seen were compared with two control groups: the first group consisted of infants with malformations not previously linked to Valproic acid and the second control group consisted of infants with chromosomal abnormalities. A large data set was used in this study, which consisted of 98,075 live births, stillbirths, or terminations with malformation among 3.8 million births.
Author of the above study, J. Jentink, states that “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).” This means that the use of valproic acid monotherapy was connected with an increased risk of several congenital malformations when compared to subjects with no use of antiepileptic drugs. A fetus that is exposed to high levels of antiepileptic drugs has an increased risk for developing major congenital malformations. For this reason, doctors recommend monotherapy whenever possible during pregnancy.
Since so many women have used Depacon or other AEDs containing sodium valproate and were unaware of the risk the drug carries for their developing baby, Depacon lawsuits have been filed around the world.
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