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Depakote Birth Defects FAQ

What is Depakote and why is it prescribed?

Depakote, known generically as divalproex, is an anti-seizure oral drug that is used to treat epilepsy or other seizure disorders and bipolar disorder. The active ingredient in both products is valproic acid. (Divalproex is converted to valproic acid in the stomach.)

Depakote was originally manufactured for the purpose of helping treat the manic episodes in those who suffer from manic depressive disorder. For a time, the drug worked wonders for manic depressive disorder, and eventually the conditions for which Depakote was prescribed expanded to include epilepsy, migraine headaches and certain symptoms associated with neuropathy, including chronic pain.

It is sometimes prescribed to treat chronic migraine headaches. Depakote is also used to control seizures, the shaking of Parkinsons disease and also to alleviate the pain of leg cramps nerve damage due to diabetes.

How Does Depakote Work?

The mechanism of action of valproic acid is unknown, but the most popular theory is that valproic acid exerts its effects by increasing the concentration of gamma-aminobutyric acid (GABA) in the brain. GABA is a neurotransmitter, a chemical that nerves use to communicate with one another. GABA inhibits the transmission of these signals and it reduces nervous excitation.

When was Depakote approved?

The FDA approved valproic acid in February 1978 and divalproex in March 1983. By 2006, valproic acid was the second most commonly prescribed epilepsy drug.

Has the manufacturer included warnings on the Depakote label?

Since 2006 a black box warning has been on the label of Depakote, made by Abbot Laboratories, warning about potential birth defects associated with use of the drug during pregnancy. As well, there is a black box warning for the following conditions:

• Hepatotoxicity (liver damage)
• Teratogenicity (fetal harm)
• Pancreatitis (inflammation or infection of the pancreas)

In 2009 the FDA added more stringent warnings about birth defects to Depakote and other drugs in the same class, which also includes Depacon, Depakine and Stavzor.

What are Depakote Side Effects?

The most severe side effects are serious and irreversible birth defects (see below). People who take this drug may experience a variety of side effects, from mild to severe. Side effects include:

• dizziness
• decreased coordination
• misbalance
• weight gain
• increased appetite
• abnormal dreams

Dangerous side effects that suggest a possibility of liver damage include:

• vomiting
• loss of appetite
• fever
• dark urine

I take Depakote for epilepsy and plan on getting pregnant. My doctor said I should stay on Depakote.

Women should not stop taking any drug without consulting their physician. Women with epilepsy are advised to have a discussion with their doctor about seizure medications at least six months before becoming pregnant. According to new guidelines developed by the American Academy of Neurology (AAN) and the American Epilepsy Society, "WebMD Health News" (April 27), women should avoid taking Depakote (valproate) during pregnancy if possible.

The FDA says, however, that Depakote and similar drugs should not be used in women who are planning a pregnancy, and that birth control should be used by all women of childbearing age who are taking the drugs. The FDA has reported neural tube defects, which often develop before a woman even knows she is pregnant.

What are other Depakote birth defects?

As well as neural tube defects, there are a number of reported Depakote birth defects, from mild autism to spina bifida to anencephaly (brainless babies). The FDA warns that Depakote, when taken by pregnant women, has been shown to increase the risk of cardiovascular malformations, craniofacial defects, and other major birth defects.

Additionally, taking Depakote during pregnancy has been linked to lower IQs in children.

What is Spina Bifida?

Spina bifida is a birth defect in which the spinal cord and backbone fail to develop or close properly. Spina bifida occurs at the end of the first month of pregnancy when the two sides of the embryo's spine fail to join together, leaving an open area. In some cases, the spinal cord or other membranes may push through this opening in the back. It is usually detected before a baby is born and treated right away.

What is the risk of having a baby born with Depakote birth defects?

The rate of overall birth defects is nearly four times higher in women taking Depakote than in women taking different anti-seizure drugs. According to the New England Journal of Medicine (June 10, 2010), children born to women who took valproic acid (Depakote or Depakene) during the first trimester of pregnancy are much more likely to have serious births defects affecting the brain, heart and limbs, and:

• 12.7 times more likely to have spina bifida
• 2.5 times more likely to have an atrial septal defect (which involves the heart);
• Five times as likely to have a cleft palate (a defect of the upper lip and roof of the mouth) or hypospadias (a penis abnormality);
• More than twice as likely to be born with an extra digit on the hand (polydactyly)
• Seven times more likely to have craniosynostosis (premature fusion of the skull during fetal development that restricts skull and brain growth).

Given this mounting evidence of the risks of valproic acid to fetuses, researchers in the study urged women of childbearing age to try an alternative drug.

My child was born with Depakote birth defects. Can I join a Depakote lawsuit?

While Depakote has been marketed as a treatment for psychiatric conditions, a similar drug called Epilim, which is used in the UK and also contains sodium valproate, has been marketed for epilepsy. A class action suit is underway in the UK involving Epilim, brought by parents who claim their children have been disabled by the anti-convulsant drug.

In the US, product liability lawyers are evaluating potential Depakote birth defect lawsuits for individuals who took valproate-based drugs during pregnancy and gave birth to babies with birth defects.

If your child suffers from birth defects associated with Depakote, including spina bifida, Depakote attorneys can help fully evaluate your child's condition and document the diagnosis, prognosis and if possible, the expected costs associated with the treatment your child will need throughout his or her life.

Are there other lawsuits against the manufacturer of Depakote?

Abbott Laboratories is currently under investigation by the US Department of Justice over its sales and marketing of the drug. Federal investigators are looking into whether the company violated Medicare or Medicaid reimbursement laws.