Fetal Valproate Syndrome and Depakote

Fetal Valproate Syndrome and Depakote use during pregnancy may be linked.  Contact an Depakote attorney about lawsuit options or joining a class action if your child has suffered birth defects resulting from Depakote use while pregnant.

Serious concerns have been raised about the safety of the anticonvulsant drug Depakote, due to new information regarding the potential link between Depakote and serious birth defects, like fetal valproate syndrome, among exposed children. Depakote has been available on the U.S. market since 1983 when it garnered FDA approval, and has since been approved for the treatment of epilepsy, seizures, migraine headaches and bipolar disorder. Depakote (valproic acid) works by interfering with the firing of certain impulses in the brain which are responsible for causing seizures. Depakote is currently manufactured by drug company Abbott Laboratories. Although Depakote has become one of the most popular anticonvulsant drugs in the U.S., recent studies have identified Depakote use during pregnancy as a potential risk factor for the development of major side effects, particularly birth defects like fetal valproate syndrome. If you took Depakote while pregnant and your child was born with a serious side effect or birth defect, contact a Depakote attorney to discuss your legal options.

What is Fetal Valproate Syndrome?

Fetal valproate syndrome describes a rare set of congenital malformations occurring together which may be linked to the use of the anticonvulsant drug valproate (Depakote) during pregnancy. Fetal valproate syndrome is characterized by side effects like central nervous system dysfunction and a distinctive facial appearance, often occurring in combination with a series of minor and major abnormalities. Children born with fetal valproate syndrome typically exhibit a variety of side effects, including:

  • Spina bifida
  • Craniofacial abnormalities
  • Developmental delay
  • Neurological problems
  • Finger abnormalities
  • Downturned mouth
  • Heart defects
  • Short nose
  • Flat nose bridge
  • Broad nose
  • Thick lower lip
  • Thin upper lip
  • Shallow upper lip groove
  • Eyebrow abnormalities
  • Musculoskeletal defects

Due to the unique nature of each individual instance of fetal valproate syndrome, there is no one treatment for this condition, and each abnormality is typically managed individually. Unfortunately, some of the birth defects associated with fetal valproate syndrome, including spina bifida and craniofacial abnormalities, can be severely life-altering and may even be fatal.

Depakote and Side Effect Studies

In 2009, the FDA issued a safety announcement warning patients and physicians about the increased risk of birth defects among children exposed to Depakote during pregnancy. According to the FDA, the birth defects potentially linked to Depakote include neural tube birth defects like spina bifida, craniofacial malformations affecting the face and skull, and heart defects. This FDA warning was based on data collected by the North American Antiepileptic Drug Pregnancy Registry, which indicated that infants whose mothers took Depakote while pregnant were four times more likely to develop major malformations than infants whose mothers took a different anticonvulsant drug during pregnancy.

In 2010, the New England Journal of Medicine published a study in which researchers sought to examine the adverse effects of fetal exposure to Depakote. According to the report, babies exposed to Depakote in utero were 12.7 times more likely to be born with spina bifida, nearly seven times more likely to develop craniosynostosis, five times more likely to be born with cleft palate, 2.5 times more likely to be born with an atrial septal defect, and more than twice as likely to develop a hand deformation.

Depakote and Pregnancy

Depakote has been classified by the FDA as a pregnancy category D medication, which means there is positive human evidence of the drug's potential to cause severe fetal harm when taken during pregnancy. Most birth defects occur during the first trimester of pregnancy, before many women are even aware they are pregnant. Because nearly half of all pregnancies are unplanned, all women taking Depakote may be at risk of unknowingly causing irreparable harm to their unborn child. If you are currently taking Depakote and you are pregnant or planning to become pregnant, consult your healthcare provider to discuss alternative treatment options.

Depakote Attorneys for Fetal Valproate Syndrome Side Effects

Due to the severity of potential Depakote birth defects like fetal valproate syndrome, the FDA has advised physicians to avoid prescribing Depakote to pregnant women, especially for conditions not usually associated with permanent injury or death. If you or a loved one has suffered from fetal valproate syndrome, which you believe to be linked to Depakote, contact a Depakote attorney to discuss your options for legal recourse. You may have grounds to file a Depakote lawsuit against Abbott Laboratories in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. You are not at fault for any injuries caused by a dangerous pharmaceutical drug. With the help of a qualified Depakote lawyer, you can protect your rights and collect the compensation you deserve.

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