In an article from the Department of Neuropsychiatry at Hirosaki University in Japan, called “Congenital Malformations Due to Antiepileptic Drugs”, author Kaneko S. writes the goal of the study was “to identify the major risk factors for the increased incidence of congenital malformations in offspring of mothers being treated for epilepsy with antiepileptic drugs (AEDs) during pregnancy and, to determine the relative teratogenic risk of AEDs, we prospectively analyzed 983 offspring born in Japan, Italy, and Canada.”
The findings in this study were that 3.1 percent of children without in utero exposure to AEDs were born with congenital malformations, while 9 percent of children with in utero exposure to AEDs were born with congenital malformations.
Author Kaneko S. further explains that, “The highest incidence in offspring exposed to a single AED occurred with primidone (PRM; 14.3%), which was followed by valproate (VPA; 11.1%), phenytoin (PHT; 9.1%), carbamazepine (CBZ; 5.7%), and phenobarbital (PB; 5.1%). The VPA dose and level positively correlated with the incidence of malformations. This study first determined a cut-off value of VPA dose and level at 1000 mg/day and 70 microg/ml, respectively, to avoid the occurrence of malformations.” (emphasis added)
It is widely accepted that monotherapy is a safer option for pregnant epileptics than polytherapy. The study supported current reports that indicate the risk of malformations increases as the number of drugs increases, and specifically, this study showed that combinations of Phenytoin, Carbamazepine, Phenobarbital, and Valproate produced a higher rate of congenital malformations. The only background factors studied were for malformations present in siblings of the patients. Further, this study indicates AEDs were responsible for the increased incidence of congenital malformations. It is also recommended that epileptic women who are pregnant should not exceed more than 70 microg/ml per day of VPA (valproic acid).
Due to the fact that in utero exposure to sodium valproate (the active ingredient in Depacon Depakene, and Depakote) has been linked to birth defects by many studies, but the manufacturer of these drugs failed to warn its users about the risk for birth defects, a number of Depacon lawsuits are currently being filed.
If you or a loved one used Depacon during pregnancy and your baby was born with a birth defect, you may be entitled to significant financial compensation for undue injury to your child. For more information on Depacon, contact our team of Depacon lawyers at the information provided below.
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