Depakote Lawsuits Filed Against Abbott Laboratories - Consumer Justice Foundation

Depakote Lawsuits Filed Against Abbott Laboratories

Written by Faith Anderson on June 15, 2011

Abbott Laboratories’ Antiepileptic, Depakote

Depakote (valproic acid) is one of the most commonly prescribed antiepileptic drugs currently on the U.S. market. The medication was approved by the FDA in 1983 and has since been used in the treatment of epilepsy and other seizure disorders, as well as migraine headaches and the manic phase of bipolar disorder. Depakote is made up of valproic acid and sodium valproate, and functions by interfering with certain impulses in the brain which are responsible for causing seizures. Although the makers of Depakote, Abbott Laboratories, have aggressively marketed the drug as an effective method of anti-seizure treatment, among other uses, a number of Depakote birth defect studies have revealed alarming results about the pregnancy risks associated with Depakote use. According to these studies, women who take Depakote during pregnancy may have a substantially increased risk of giving birth to infants with life-altering and even fatal birth defects.

Birth Defects Potentially Linked to Depakote Use in Pregnancy

In light of information provided by Depakote birth defect studies, the FDA has classified Depakote as a pregnancy category D medication, which means positive human evidence has shown an increased risk of birth defects among children exposed to Depakote during pregnancy. In 2009, the FDA issued a safety announcement warning patients and healthcare professionals about this Depakote birth defect risk, citing information provided by the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The FDA notice included neural tube birth defects like spina bifida, heart malformations, and craniofacial defects like cleft palate. Other birth defects potentially associated with Depakote include:

  • Growth retardation
  • Skeletal birth defects
  • Facial dysmorphism
  • Hand deformations
  • Fetal death
  • Hypoplasia
  • Hypoplastic right heart syndrome
  • Iniencephaly
  • Hydranencephaly
  • Fetal valproate syndrome


According to NAAED Pregnancy Registry, Depakote use during pregnancy increases the risk of major malformations among infants. For example, neural tube birth defects affect approximately one in 1,500 babies in the United States; in infants whose mothers take Depakote during pregnancy, the risk of neural tube birth defects increases to a shocking one in twenty babies. In addition, data from the NAAED Pregnancy Registry indicates that the rate of major malformations among infants born to women with epilepsy taking Depakote is nearly four times higher than the rate among infants born to women with epilepsy who take a different antiepileptic drug.

The FDA has warned healthcare professionals that Depakote use during early pregnancy increases the risk of major malformations in exposed infants. According to the agency, the rates for neural tube birth defects in children exposed to Depakote during the first trimester are thirty to eighty times higher than the rate for neural tube defects in the general U.S. population. Because of the dangers potentially associated with Depakote, the FDA has advised physicians to avoid prescribing Depakote to pregnant women and women of childbearing age, especially when the drug is considered for a condition not usually associated with permanent injury or death.

How a Depakote Attorney Can Help

Most birth defects are established during the first trimester of pregnancy, before many women are even aware they are pregnant. Unfortunately, because nearly half of all pregnancies are unplanned, all women of childbearing age taking Depakote may be at risk of unknowingly causing irreversible harm to their unborn child. Many of the birth defects allegedly associated with Depakote are severe and have the potential to cause long-term complications for an affected child. Regrettably, the medical expenses associated with seeking proper medical care for children with birth defects can also be an overwhelming financial burden for the families of birth defect victims.

A number of parents have taken the first step in seeking financial compensation for their child’s injuries: filing a Depakote lawsuit against Abbott Laboratories. Filing a defective drug lawsuit can be a complicated and emotional process; fortunately, there are experienced Depakote attorneys available who have the qualifications necessary to help birth defect victims and their families fight for their rights. If you took Depakote while pregnant and your child was born with a serious birth defect, don’t wait. Depakote birth defect claims are being investigated by Depakote lawyers across the country on behalf of families whose lives have been adversely affected by the anticonvulsant drug, Depakote. Your child may be entitled to lifetime care or financial compensation for his injuries, which you can collect by filing a Depakote lawsuit or Depakote class action lawsuit against Abbott Laboratories.

Posted Under: FDA - Food and Drug Administration
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