Research shows the anticonvulsant drug divalproex sodium—sold under the brand name Depakote (and, less commonly, as Epival)—might cause disfiguring birth defects and autism spectrum disorder in children born to users.
What Is Depakote? When Is Prescribed?
Depakote is the brand name for the drug divalproex sodium. Made and sold by Abbott Laboratories, this prescription medication is used to treat epilepsy. It can also be used for depression, migraine headaches, and bipolar disorder. The U.S. Food and Drug Administration (FDA) first approved Depakote in 1983, and it has been available in generic form since 2008.
Divalproex sodium is a compound of equal parts sodium valproate and valproic acid, 125mg to 500mg per oral dose. The chemicals are “enteric coated,” meaning the pill’s shell dissolves in the small intestine for absorption rather than in the stomach, which would damage the active compound. Unlike other anticonvulsants, Depakote is a GABA transaminase inhibitor. The GABA system is the primary neurotransmitter that regulates neuron activity in the nervous system, and by inhibiting it, Depakote reduces convulsions caused by epilepsy.
Recent controversies have shaken consumer confidence in Depakote. In a rare move, the U.S. Department of Justice (DOJ) in February 2011 intervened in a qui tam (i.e., “whistleblower”) lawsuit brought by three current or former Abbott Laboratories employees under the False Claims Act, which forbids pharmaceutical companies from paying doctors to prescribe their drugs for off-label uses (that is, uses not approved by the FDA). Abbott Laboratories had allegedly conducted pseudo-seminars to “educate” doctors on Depakote’s off-label effects on people with Alzheimer’s disease or dementia. The pharmaceutical company also had allegedly paid doctors kickbacks for prescribing Depakote, marketed the drug to nursing home staff, and even obtained favorable ghostwritten studies on Depakote published in medical journals. According to the Chicago Tribune, in October 2011, Abbott agreed to settle with the DOJ and 24 state governments for $1.3 billion. Subsequently, Abbott Laboratories shareholders filed a derivative lawsuit.
Potential Side Effects Include Birth Defects and Suicide
In 2006, the FDA required Abbott Laboratories to place a “black box” warning on Depakote’s packaging warning users and physicians that Depakote causes birth defects in children. This requirement, which applies as well 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
- septal defects in the heart
In late 2008, after reviewing clinical data, the FDA required an additional black box warning, this one specifying that Depakote increases the chances that its users will attempt suicide.
In December 2011, a Danish study of 656,000 children born between 1996 and 2006 found that valproate use during pregnancy contributed to a 2.6 times increase in the likelihood of autism spectrum disorder birth defects. Fourteen of 508 children (2.8 percent) born to mothers who took valproate during pregnancy were born with autism, but the percentage for unexposed children was only 0.8 percent.
The FDA issued a Depakote birth defects warning on May 6, 2013, stating that Depakote use during pregnancy to treat migraines might cause cognitive impairments in children. According to the FDA’s drug safety communication, research had shown that children born to women who used Depakote during pregnancy had lower IQs by 8 to 11 points by age six. Other researchers have found similar results when testing three-year-olds.
While no Depakote recall has been issued, one Depakote birth defect class action lawsuit was filed in March 2011 in St. Clair County Circuit Court in Illinois. Numerous individual lawsuits have been commenced there as well.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you have suffered can be complicated, even if it does not seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed your child shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Depakote lawsuit on your behalf if necessary.
If you or partner has taken Depakote and believe it harmed your child, contact RLG today.