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Depakote Causes Birth Defects When Taken in Early Pregnancy

By Burg Simpson
May 7, 2013
3 min read

Depakote (divalproex sodium), also known as valproic acid, is a prescription drug sold by Abbott Laboratories.  Depakote is prescribed to treat seizures as well as with bipolar disorder and migraine headaches.  Unfortunately, Depakote is also a known teratogen, meaning it is a drug that can cause birth defects.  .  Depakote has recently been changed to a Pregnancy Category X for the treatment of migraines during pregnancy, meaning that the drug cannot be prescribed for pregnant women to treat migraines due to the substantial risk of birth defects.  For the treatment of bi-polar disorder and seizures, Depakote is only recommended if other treatments have failed and the drug is considered an essential treatment.  (FDA Announcement, May 6, 2013.)

Research studies have concluded that compared to other anti-seizure medications, Depakote causes an increased risk of cognitive and neurobehavioral impairments, such as low IQ and Autism Spectrum Disorders.  According to the Diagnostic and Statistical Manual of Mental Health Disorders, Fourth Edition (DSM-IV), Autism Spectrum Disorders include the following: Autistic Disorder, Asperger’s Disorder, Pervasive Developmental Disorders not otherwise specified, Rett’s Disorder and Childhood Disintegrative Disorder.

Depakote has also been associated with an increased risk of neural tube defects, including spina bifida.  While the rate of neural tube defects in the general population is 0.1 to 0.2%, the incidence rate in children of women exposed to Depakote in the first trimester (first three months) of pregnancy is ten times higher.  Thus the Centers for Disease Control reports a rate of 1% to 2% for neural tube defects among children born to women taking Depakote in early pregnancy.

In addition, medical journal articles describe an increased rate of other major malformations, such as craniofacial and cardiovascular defects, among women using Depakote.  For example, increased rates of cleft palate, as well as heart defects (such as atrial septal defect), polydactyly (multiple fingers or toes), craniosynostosis (premature closure of sutures in skull) and hypospadias (abnormal location of urethra in males) are reported among children born to women using Depakote.  (N Engl J Med, 2010 Jun 10:362(23): 2185-93.)  The increased risk of birth defects for Depakote users is seen both in comparison to women with seizure disorders who used no medication during pregnancy, and those who used a different anti-seizure medication during pregnancy.  The same increased risk is expected to be seen in women who use Depakote for migraine headaches and bipolar disorder.

The attorneys at Burg Simpson are experienced in litigation involving prescription drugs, and in the complex medical and legal issues concerning birth defects caused by medication.  If you or a loved one have suffered injury due to the use of  Depakote during pregnancy, please contact us for a confidential consultation.  Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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