Depakote Birth Defect Investigation

Stueve Siegel Hanson is investigating the prescription drug Depakote related to an increased risk of birth defects.

Depakote is the brand name for the drug divalproex sodium and is used to treat various types of seizure disorders such as Epilepsy.  It has also been used to treat bipolar disorder and migraine headaches.  Although Depakote is manufactured by Abbott Laboratories, there are several generic forms of the drug manufactured by Mylan, Dr. Reddy’s, Lupin, Sandoz, Sun, Teva and others.

The U.S. Food and Drug Administration (FDA) approved Depakote in 1983 for epilepsy treatment, in 1995 for bipolar disorder and in 1996 for the prevention of migraine headaches. The drug comes in a variety of forms: Depacon injections (valproate sodium), Depakote, Depakote CP and Depakote ER (divalproex sodium) and Depakene and Stavzor (valproic acid).

Depakote has been approved for use in adults and children 10 and older for seizure treatment and age 16 and older for migraine prevention. It is not approved to treat bipolar conditions in children, although it has been known to be used in this off-label manner. In 2008, the FDA approved the first generic version of Depakote.

Depakote tablets are “delayed-release,” which means they have a special coating that prevents the drug from dissolving too early in the digestive tract. Depakote works by increasing the amount of the neurotransmitter gamma amminobutyric acid (GABA) in the brain. GABA carries messages between brain cells and soothes overstimulated nerves.

FDA Warning

In 2006, the FDA required Abbott Laboratories to place a “black box” on Depakote’s packaging warning users and physicians that Depakote causes birth defects in children. This requirement, which applies to subsequent manufacturers of Depakote’s generic equivalents, was issued in response to a study showing that Depakote users’ babies are more likely to suffer birth defects than the babies of patients who use other anticonvulsants. This study was published in the medical journal Neurology. A study from the New England Journal of Medicine showed that Depakote caused the following defects:

  • Cleft palate;
  • Neural tube defects;
  • Spina bifida;
  • Cognitive impairments (measured in low IQ);
  • Abnormal skull formation;
  • Malformed limbs;
  • Extra fingers or toes;
  • Urinary problems; and
  • Septal defects (heart problems).

In late 2008, after reviewing clinical data, the FDA required an additional black box warning, this time specifying that Depakote increases the chances that its users will attempt suicide.

Researchers also discovered in May 2010 that side effects and birth defects caused by use of Depakote while pregnant could result from use of the drug in any trimester, including the first. In other words, by the time a woman who is pregnant discovers she is pregnant; she might no longer have time to stop using the drug and subsequently prevent the development of birth defects in the growing fetus.

In June 2011, the United States Food and Drug Administration (FDA) released information regarding a study indicating that if a mother took valproate sodium products like Depakote while being pregnant that her child would have a lower IQ and would score lower on other cognitive tests in comparison to those who were not exposed to anti-seizure drugs. 

In early 2013, two studies were published that found that Depakote use increased the risk of developmental delays, impacting memory, verbal skills and executive function. One study found an increase in the risk of autism as well, echoing the findings of a 2011 study by Danish researchers.

Abbott Laboratories and other manufacturers knew or should have known that their medication may put pregnant women at increased risk of having a child with Depakote birth defects and malformations, but failed to warn consumers of the risks involved with using their drugs.

Despite being recognized as a potentially dangerous drug by many medical professionals, Depakote continues to be prescribed as a treatment for bipolar mania, migraines, and epilepsy. Anyone who has taken Depakote has a loved one who has taken Depakote, or is considering Depakote should be aware of the potential side-effects and dangerous symptoms.

If you or someone you know has experienced serious side effects caused by Depakote and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.



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