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Depakote Linked to Neural Tube Birth Defects | Spina Bifida | Anencephaly | Encephaloceles

April 11, 2012

Depakote (a pharmaceutical name for valproate semisodium) has been prescribed as a mood stabilizer since the late 1970s, particularly for sufferers of epilepsy. Today, the medication is mostly used to treat bipolar disorder (manic depression) and migraine headaches. It has proven to be incredibly effective in this capacity, but recent studies have shown a strong link between mothers taking the drug and babies born with neural tube defects.

We first explained neural tube defects in a post explaining how failure to prescribe folic acid can lead to spina bifida and other neural tube disorders. It goes into detail about the importance of women getting sufficient b-vitamin folic acid during the early weeks of their pregnancy. However, another contributing factor is Depakote (which is also sold under the names Depakene, Epilim, and Stavzor). Neural tube defects, also known as NTDs, are an umbrella term for birth defects like spina bifida, anencephaly, and encephaloceles. The neural tube is the structure in a maturing baby that will eventually surround its brain and spinal cord, and its proper growth will in turn promote healthy development of the brain and spinal cord.

Approximately 1 in 1,500 babies are born with NTDs, but for babies born to mothers taking a form of valproate during the first trimester, the rate increases substantially to 1 in 20. In other words, the birth defect rate can be up to 80% higher for those mothers taking valproate in any of its forms. Additionally, children exposed to valproate under the age of two have reported serious liver conditions. These findings are well established. Doctors are responsible for counseling their female patients regarding the dangers Depakote poses and failure to do so could be considered medical malpractice.

Both the National Institute for Health (NIH) and the FDA have issued advisories about the drug. The FDA’s safety alert regarding babies exposed to valproate sodium and other related products during the mother’s pregnancy reads in part:

“The FDA is reminding health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy…Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

Reports of complications in newborns have ranged from the above-mentioned NTDs, cognitive impairment, and autism spectrum disorders. A 2009 study in the New England Journal of Medicine says, “At 3 year of age, children who had been exposed to valproate in utero had significantly lower IQ scores than those who had been exposed to other antiepileptic drugs.”

In addition to these heartbreaking statistics, WebMD has listed six birth defects that occur more frequently in pregnant women taking valproate than in those not taking the drug:

– Spina bifida
– Atrial septal defect (hole in the heart)
– Cleft palate
– Hypospadias (a genital abnormality in boys)
– Polydactyly (extra fingers and/or toes)
– Craniosynostosis (an abnormality in newborns’ skulls)

This medication is especially dangerous to babies because their mothers often do not know they are carrying a child until a few weeks into their pregnancy. Most neural tube defects occur during this phase. If you know of a child who suffers from any of these ailments and their mother was taking Depakote during pregnancy, their problems could have been prevented. With vigilance and careful planning on the part of a doctor, valproate-prescribed mothers can usually avoid such tragic defects.

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