Cincinnati, OHThe goal of a new 10-year study involving 550 women is to understand if there are differences in how anti-epileptic drugs, namely Depakote, affect both mother and child. The last study of its kind, published in 2009, advised that valproate (brand name Depakote) not be used as the first anti-seizure drug of choice in women of childbearing age.
The $8.9 million study is now underway in 20 medical centers, including the University of Cincinnati Medical Center. It is sponsored by the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development.
According to Medscape, some one million American women of childbearing age in the US have some type of seizure disorder and about 20,000 of them have children in a typical year. These pregnancies include the risk of birth defects, miscarriage, perinatal death and increased seizure frequency. Many women don’t realize they are pregnant during the first trimester: Sadly, a number of women on epilepsy meds whose babies were born with Depakote birth defects believe the risk of seizure outweighs the benefits of staying on Depakote. One current lawsuit was filed by a woman who took Depakote before she knew she was pregnant, and her child was born with an extra digit.
Last December 2013, a US Magistrate Judge ordered Abbott Laboratories, the Depakote manufacturer, to produce “long overdue” documents in Depakote lawsuits alleging birth defects (US District Court for the Southern District of Illinois, case no. 13-cv-324-SCW, and 13-cv-326-SCW), according to court documents. The company was ordered to “exercise all avenues available” to produce approximately 4,000 documents related to the case.
Meanwhile, more Depakote lawsuits in Illinois federal court are moving forward. The lawsuits allege that Depakote taken during pregnancy caused Depakote birth defects, including spina bifida, heart defects, neural tube defects, and other congenital malformations and injuries.
One plaintiff who was prescribed Depakote during her pregnancy claims that her daughter was diagnosed with life-threatening severe scoliosis that could affect her lungs and heart. Another woman who took Depakote during her pregnancy believes it caused her son’s undescended testicle, which required surgery.
Researchers in the new study say that babies of epileptic mothers suffer anatomical birth defects at roughly twice the rate as other babies. The mothers also face potential problems, ranging from seizures and depression to the challenge of switching medications to additional complications such as C-section births. If only the findings of the 2009 study received more attention...
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