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Anticonvulsant Drugs DEPAKOTE Fetal Valproate Syndrome

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Depakote and Fetal Valproate Syndrome Birth Defects

If your baby was born with fetal valproate syndrome and Depakote was taken during pregnancy, your child may be entitled to lifetime care.

There are a number of prescription anticonvulsant medications on the market, drugs which were initially designed to treat epileptic seizures, but have since been used to treat a number of other medical conditions as well. One of the most popular forms of antiepileptic drugs on the U.S. market is Depakote, a medication currently manufactured by Abbott Laboratories. Depakote consists of valproic acid and sodium valproate, and the drug functions by slowing down impulses in the brain which cause seizures. Depakote was originally approved by the FDA in 1983 and has since been prescribed to individuals suffering from epilepsy and other seizure disorders, as well as migraine headaches and bipolar disorder.

Unfortunately, several potential adverse side effects of Depakote treatment have been reported in recent years, particularly the increased risk of major birth defects among infants exposed to the drug in utero. According to research over the past few years, infants whose mothers take Depakote while pregnant may significantly increase their chances of giving birth to children with one or more severe birth defects. In fact, the FDA has required Abbott Laboratories to update Depakote's label to include a "black box" warning, informing Depakote users about the teratogenicity of the drug. Teratogenicity is defined as a drug's potential to disturb fetal development, resulting in fetal malformations. Among these alleged Depakote birth defects is a devastating congenital condition called fetal valproate syndrome.

Fetal Valproate Syndrome Described

Fetal valproate syndrome is the name of a rare congenital disorder which may be caused by an infant's exposure to valproic acid, the active ingredient in the anticonvulsant drug, Depakote. This condition is characterized by a distinctive facial appearance, central nervous system dysfunction, and may be accompanied by a number of additional minor and major birth defects such as growth retardation. Infants born with fetal valproate symptom often experience a variety of symptoms, including:

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

There is currently no treatment available for infants with fetal valproate syndrome, and each symptom of the condition must be managed individually. Unfortunately, many of the congenital disorders associated with fetal valproate syndrome are life-threatening and some may even be fatal.

Depakote and Birth Defects

The congenital birth defects most commonly associated with fetal valproate syndrome are heart defects, neural tube birth defects like spina bifida, oral clefts like cleft palate, genital abnormalities, and limb defects. According to research, infants whose mothers take Depakote during pregnancy have a significantly increased risk of developing these birth defects, among others. The New England Journal of Medicine published a study in 2001 which indicated that 20.6% of infants exposed to an antiepileptic drug during pregnancy developed birth defects, compared to 28% of infants exposed to two or more anticonvulsants in utero, and 8.5% of infants whose mothers took no antiepileptic drugs while pregnant. These birth defects included growth retardation, hypoplasia of the fingers, and hypoplasia of the midface, and the anticonvulsant drugs taken by women in the study included Depakote (valproate), Dilantin (phenytoin), and Tegretol (carbamazepine).

The journal Neurology published a study in 2005 in which researchers determined that women who took Depakote during the first trimester of pregnancy had a significantly increased risk of giving birth to infants with major birth defects. According to the report, infants who were exposed to Depakote in utero were four times more likely to be born with birth defects compared to infants exposed to other antiepileptic drugs during pregnancy. Among these birth defects were heart defects, spina bifida, and developmental delay.

Another NEJM just recently published in 2010 indicated that Depakote use during the first trimester of pregnancy significantly increased a woman's risk of giving birth to infants with serious birth defects. More specifically, the risk for heart defects, cleft palate, hand deformations, and skeletal defects was two to seven times higher for infants exposed to Depakote, and the risk for spina bifida was twelve to sixteen times higher in exposed infants.

Depakote use During Pregnancy

Depakote is considered a pregnancy category D medication by the FDA, which means there is positive human evidence of the drug's potential to cause significant harm to a fetus when taken during pregnancy. The FDA also recently issued a safety announcement warning patients and healthcare providers about the increased risk of birth defects among infants exposed to Depakote in utero. The birth defects included craniofacial malformations like cleft palate, neural tube birth defects like spina bifida, and heart defects. If you are currently taking Depakote and you are pregnant or planning to become pregnant, consult your physician as soon as possible to discuss alternative treatment options. It is never advised to discontinue use of a prescription medication without medical consent, as this can cause further adverse side effects. However, with the help of your doctor, you may be able to find a safer way to treat your medical condition.

Fetal Valproate Attorneys Can Help

Fetal valproate lawyers want victims of serious injuries potentially associated with the use of a defective drug to know that they are not at fault. If you or a loved one has suffered from fetal valproate syndrome and you believe the antiepileptic drug, Depakote, to be the cause, contact a Depakote attorney for help. Fetal valproate syndrome is so closely linked to the use of Depakote that the condition is actually named after the drug's active ingredient, valproate. Unfortunately, many infants born with this condition struggle with a number of additional life-threatening disorders which may require costly, long-term medical treatment. The goal of Depakote lawsuits and potential Depakote class action lawsuits is to hold the allegedly negligent manufacturing company responsible and to seek financial compensation for your injuries.

You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Depakote lawsuit against Abbott Laboratories. Drug manufacturing companies are responsible for developing and marketing safe medications and should be held accountable for the adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally withhold this information from the public in order to prevent negative consequences like a recall. This puts consumers unknowingly at risk of suffering life-altering side effects which could have been avoided had the appropriate information been shared by the manufacturing company. The only way for consumers to protect their rights and stand up to big drug companies is to hire a Depakote lawyer to represent their case.

Depakote Drug Info

Manufacturer:

Abbott Laboratories

Generic Equivalent:

Divalproex Sodium

Depakote Uses:

  • Epilepsy
  • Bipolar Disorder
  • Migraine Headaches

FDA Approval:

1983

Pregnancy Side Effects:

  • Cleft Palate
  • Facial Dysmorphism
  • Fetal Death
  • Fetal Valproate Syndrome
  • Growth Retardation
  • Hand Deformations
  • Heart Defects
  • Hydranencephaly
  • Hypoplasia
  • Hypoplastic Right Heart Syndrome
  • Iniencephaly
  • Neural Tube Birth Defects
  • Skeletal Defects
  • Spina Bifida

FDA Actions:

  • Pregnancy Category D
  • Black Box Warning Requirement

Tell Family And Friends


Spread the word so women are aware of the risks for both anticonvulsant birth defects and antidepressant birth defects and so families dealing with the hardship and expenses of lifetime care can get financial help from experienced class action attorneys. Learn more about Side Effects from prescription drugs.


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