Depakote is used to treat epilepsy, bipolar disorder, and migraines. In the 30 years since its approval, many patients have claimed Depakote caused severe harm and side effects, including birth defects, and now they are filing lawsuits.
The U.S. Food and Drug Administration approved Depakote for the treatment of epilepsy, bipolar disorder, and migraines. While the drug has helped patients manage difficult disorders and debilitating headaches, patients who have taken the drug have also reported horrific side effects.
One of Depakote’s more severe side effects is birth defects to fetuses, leading to the FDA issuing strong warnings about its risks when taken by women during pregnancy. Victims of birth defects and other severe side effects caused by Depakote have fought back in court through lawsuits. Several cases have already gone to trial with more new lawsuits being filed every month.
What is Depakote?
Depakote is the brand name for the drug divalproex sodium. It is a type of mood stabilizer made up of sodium valproate and valproic acid, according to RXList.1 It comes in three different forms, including Depakote, Depakote ER (extended release), and Depakote Sprinkle Capsules (delayed release).
Sodium valproate was first discovered2 back in 1881, but its medicinal benefits were not identified until the 1960s. It is still not clear how Depakote works, however it is believed3 that it may increase concentrations of a neurotransmitter called GABA to help stabilize moods. GABA plays a role in calming overstimulated nerves.
Depakote was first approved for use in the United States back in 1983 when manufactured by Abbott Laboratories, and is one of the first iterations of a class of drugs known as antiepileptics.4 Since it’s introduction, it’s been prescribed to millions of patients around the world.
In 2013, Abbott Laboratories separated into two companies. One of them, AbbVie, assumed all rights and responsibilities with relation to Depakote.
Approved Uses for Depakote
The FDA has approved Depakote for three uses. Here is a closer look at each.
The first approved use for Depakote was for the treatment of epilepsy. Epilepsy is a neurological disorder characterized5 by unpredictable seizures and other health problems. It may be caused by a brain injury or genetics. About 2.2 million people6 are thought to have epilepsy in the United States alone.
Depakote was also approved for treatment of manic episodes associated with bipolar disorder. Some estimates7 say nearly 3 percent of American adults had bipolar disorder in the last year.
In 1996, the FDA approved Depakote for migraine headache prevention. About five million people in the United States report having at least one migraine attack per month, so the prospect of a preventative treatment was significant. The initial dose is 250mg twice per day, according to the National Headache Foundation.8
Depakote Side Effects
Side effects occurring among patients taking the drug range widely in both type and severity.
Common Side Effects
- Stomach pain
- Blurry vision
- Double vision
- Increased appetite
- Weight gain
- Hair loss
- Loss of appetite
- Problems with walking or coordination
Serious Side Effects
- Allergic reactions
- Extreme drowsiness
- Increased ammonia levels
- Birth defects
- Suicidal thoughts
- Liver damage
- Pancreas damage
More information can be found at Depakote.com.9
Depakote Linked to Birth Defects
Among the most serious side effects associated with Depakote are birth defects. Women who took Depakote during pregnancy have reported children with a range of birth defects, including spina bifida, low IQs, cleft palates, limb deformities, skeletal defects, and more.
In 2006, the FDA added a black box warning — the strongest warning issued by the FDA — to Depakote’s label for birth defects. This followed a study10 that found major congenital malformations and fetal deaths were far more common among pregnant women taking Depakote than other antiepileptic medications. An alarming 20.3% of pregnant women taking Depakote saw birth defects in their children.
Three years later, the FDA added another warning about neural tube defects. A study in the New England Journal of Medicine11 concluded that using Depakote “was associated with significantly increased risks of several congenital malformations.”
The FDA then issued yet another warning12 in 2011 regarding impaired cognitive impairment in children whose mothers took valproate products like Depakote.
Federal Depakote Lawsuits Settled for $1.5 Billion
Patients who experienced severe side effects would go on to file lawsuits against Abbott, and later AbbVie. Before that, the Department of Justice went after Abbott over accusations that the company promoted Depakote for off-label uses.
In 2012, Abbott agreed to pay13 $1.5 billion to resolve criminal and civil investigations after the government accused the company of promoting Depakote for use in dementia patients in nursing homes. Not only was this an illegal act because its use in dementia patients was not approved by the FDA, but it also put the patients at risk for unknown side effects.
Depakote Class-Action Suits & Lawsuits
Depakote users claimed that the company knew about the drug’s risks, but failed to adequately warn both patients and doctors. They also claimed that the drug was defectively designed.
Although the first cases were filed in state court in 2010, cases related to birth defects did not go to trial until 2015. By then, hundreds of other users had also filed lawsuits. Individual lawsuits are usually more common than class-action lawsuits in defective drug cases.
In a March 2015 trial, the parents of a boy born with spina bifida argued that Depakote caused his defect, but the jury found in favor of Abbott. The pharmaceutical company suffered its first loss in May 2015 after a jury ordered14 the company to pay $23 million in punitive damages and $15 million in compensatory damages to a girl who was born with spina bifida after her mother took Depakote during pregnancy.
AbbVie and plaintiffs could not agree on a settlement, so additional trials were set.
As of mid-2017, Abbott won three out of the six trials related to birth defects caused by Depakote. Another suit was settled before going to trial in 2016, but the terms of the agreement were not disclosed.
In January 2018, Abbott and more than 200 plaintiffs asked the judge to pause the dozens15 of cases pending in court so the two could engage in settlement negotiations.
Along with lawsuits related to birth defects, some families have started pursuing wrongful death lawsuits over allegations that Depakote caused their loved ones to commit suicide. Those who have been harmed by Depakote are encouraged to contact a qualified attorney.