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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2002 – Large study proposed to evaluate safety of AEDs during pregnancy

Posted in Depacon / Depakene / Depakote

There are many risks involved with the harmful effects antiepileptic drugs have on a developing fetus or embryo.  Despite the studies that have been done on this subject, the risks involved with the new generation of AEDs are not well known, and many questions still remain.  There is a clear connection between the amount of AEDs exposed to a developing fetus and an increased risk of major congenital malformations found in the offspring, and monotherapy is widely regarded as the more safe method to treat the epilepsy of pregnant women.  The complexity of the mechanisms involved requires large population based studies to accurately understand the risks involved.  Objectives of these studies should be the evaluation of the risk of fetal malformations, delay in prenatal growth, assessment of the pattern of congenital malformations, and if possible, identify possible relationships with dosage and elevated risks for major congenital malformations.

Author D. Battino, from the Neurologic Institute of Milan, Italy, worked on a study called “Malformations in the Offspring of Pregnant Women with Epilepsy.  Presentation of an International Registry of Antiepileptic Drugs and Pregnancy”, where he explains the study: “All women exposed to antiepileptic drugs at the time of conception are eligible for entry. The protocol is purely observational and does not entail any change in prescribing pattern or management policies, which are left to the discretion of the treating physician. Data obtained during prospective monitoring for up to 1 year after birth are regularly collected in specially-designed forms and entered into Regional Registries prior to transfer to a Central European Registry of Antiepileptic Drugs and Pregnancy (EURAP).”

Incidence and prevalence of teratogenic endpoints were based on cases enrolled before the outcomes were known and only in the first 16 weeks of pregnancy.  This study is being done in 19 countries in Western and Eastern Europe.  The study called for participation from many physicians, and was essential for the success of the objectives.  In the future, these objectives are expected to lead to important advances in clinical management of women with epilepsy, and prepregnancy counseling.

This study will go great lengths to help determine the safety of antidepressant medications during pregnancy.  For now, epilepsy must be treated on a case-by-case basis.  While many doctors suggest that monotherapy is the best choice, polytherapy is the only effective treatment for some women.  What we do know, however, is clear: many study have shown connections between antiepileptic drug use, particularly Depacon use, and an increased risk for birth defects.

If you or someone you know used AEDs or Depacon during pregnancy and had a child who suffers from a congenital malformation, do not hesitate to contact our team of AED and Depacon birth defect lawyers at the information provided below.

(855) 452-5529


Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.