Appearing in the July-August, 2009 edition of the Spanish medical journal, Neurologia, a piece titled “Malformations and fetal death in the Spanish antiepileptic drug and pregnancy registry: results at 6 years” by M. Martinez Ferri et al. aimed to “study the incidence of major congenital malformations (MCM) /and/or fetal-perinatal death (MFP) and determine his relationship to AEDs in the Spanish EURAP registry.” Over the last two decades, dozens of studies have shown that prenatal exposure to antiepileptic drugs containing sodium valproate (the active ingredient in Depacon, Depakene, and Depakote) is linked to increased risk for a range of serious birth defects.
In this study, “After informed consent, patients were included in the prospective Registry and evaluated: at the beginning, at the end of the second and third trimester, after delivery and one year after birth. A variety of variables were collected: demographic, type of epilepsy, frequency of seizures during pregnancy, AEDs and dose, potential toxics, folate use and dose, obstetric complications and information of the newborn. After 6 years of recruitment (June 2001-October 2007) we analyzed the results of this Registry in Spain with special attention on the incidence of major congenital malformations and foetal-perinatal death.”
The team states “Of a whole of 540 cases included in the Registry, 490 were prospective (included before the 16th week), of these we had complete information in 368 cases. Major congenital maLformations were present in 5% (n=13) of the child exposed to monotherapy and 12% (n=6) of those exposed to polytherapy (p=0.08). All polytherapy combinations with MCM, contained valproate.”
“The percentage of MCM was superior for valproate, particularly at doses equal or superior of 1000 mg/day (16%), although differences were not statistically significant. The majority of ours patients were on monotherapy (83%) with AEDs at low doses and were taking 5 mg of folate.”
Concluding that “Patients on polytherapy, particularly those with valproate in combination present more risk of MCM”, “For monotherapy exposures only weight at birth and the AEDs used have association statistically significant with MC/MFP”, and “Valproate in our series presents more risk than lamotrigine and does not show differences with regard to carbamazepine”, this article can be used in a Depacon birth defect lawsuit to demonstrate to a court that the manufacturers of these drugs knew, or should have known the risks of Depacon and failed to act.
If you or a loved one used Depacon, Depakote, or Depakene in pregnancy and your child was born with a birth defect, you may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of Depacon birth defect lawyers at the information provided below. We have the compassion, experience, and resources required to win the justice you deserve. Call today and see how we can help.
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