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.