Over the past 30 years, studies have shown that antiepileptic drugs (AEDs) are capable of interfering with development an embryo, potentially causing serious birth defects and developmental malformations. The ability of AEDs to harm an embryo fetus is associated with etero exposure and a dose-response relationship has been highly accepted in the medical world, and the occurrence of congenital malformations may have to do with the genetic differences in metabolic pathways which can affect individual responses to a medication.
Tests done on both human and animal patients have shown the teratogenic capacity of AEDs. Author Dansky LV, from the Neurogenetics Unit, Montreal Neurological Institute, P.Q., wrote an article called “Parental Epilepsy, Anticonvulsant Drugs, and Reproductive Outcome: Epidemiologic and Experimental Findings Spanning Three Decades; 2: Human Studies”, where he states that “Areas that require further amplification and clarification in future studies are the relative contribution of AEDs and other factors, such as genetic predisposition and maternal seizures, particularly with respect to the occurrence of minor anomalies, growth retardation, and developmental outcome; the relative teratogenicity of specific monotherapies and polytherapies; the predictive role of pharmacogenetic differences in the metabolism of AEDs in the occurrence of structural and functional abnormalities; and characterization of the precise nature of the pharmacogenetic defect underlying the aforementioned differences in AED metabolism.”
It is widely accepted that monotherapy is a safer route for epileptic women than polytherapy. Polytherapy has shown to greatly increase the risk of major congenital malformations (MCMs) in the offspring of epileptic women. Animal trials have shown that low levels of AEDs exposed to the fetus may not have as great of an effect on physical parameters, but the same cannot be said for the mental and neurologic development of the offspring. Much more research on the subject of mental/neurological development vs. growth development is needed to have a clear understanding about the drugs total effects on the fetus or embryo.
Author Dansky LV, further concludes that “Future investigations would be conducted through collaborative studies that would encompass sufficiently large numbers of women to provide adequate power to the statistical analyses of the data obtained. Care would have to be exercised to establish a uniform protocol for the collaborating centers. Regionally based investigations would be preferable to studies based at special centers, in order to assess the relative role of risk factors associated with abnormal pregnancy outcomes in the epileptic population at large.”
One commonly-used AED currently on the market is Depacon, manufactured by Abbott Laboratories. Sadly, Abbott has failed to warn women of the risks Depacon carries for developing babies and a number of Depacon lawsuits have ensured. This article may be used in a Depacon lawsuit to help provide evidence that Abbott knew, or should have known, the risks associated with Depacon.
If you or a loved one used Depacon and your child was born with a congenital malformation, you may be entitled to significant financial compensation by means of a Depacon lawsuit. For a free, no-obligation case consultation, please do not hesitate to contact our team of Depacon lawyers at the information provided below.