Depakote FAQ

Depakote (divalproex sodium) is an anticonvulsant drug and mood stabilizer used to treat conditions such as epilepsy, bipolar disorder, and migraines. Depakote is also known as valproic acid. It prevents the breakdown of the brain chemical GABA (gamma-aminobutyric acid).

In recent years, experts have linked Depakote to adverse side effects. Specifically, plaintiffs claim that this medication leads to an increased risk of congenital disabilities. In this article, you'll find information about these side effects, FDA warnings, and lawsuits related to Depakote.

How Does Depakote Work?

GABA is a calming agent in the brain. Its presence keeps the brain cells from firing signals too rapidly. If there's too little GABA in the brain, the brain cells can become overactive, causing brain activity to become overstimulated. GABA levels must be maintained at a certain level. This is why Depakote helps treat conditions marked by excessive brain activity, such as epilepsy and the manic phase of bipolar disorder.

You can take Depakote in conjunction with selective serotonin reuptake inhibitors (SSRIs). SSRIs help alleviate the symptoms of depression by increasing the amount of serotonin in the brain. This elevates mood and brain function.

While most doctors use this drug to treat seizure disorders, some healthcare providers prescribe Dekapote or Depakene to patients who have schizophrenia as well. The pharmaceutical companies have marketed the medication for this off-label use.

Common Depakote Side Effects

One of the reasons there have been so many Depakote lawsuits is that patients taking the drug may experience specific adverse side effects. Most of the side effects from the use of Depakote are minor.

Some common, mild side effects of Depakote include:

• Nausea
• Drowsiness
• Diarrhea
• Vomiting
• Trembling
• Significant Weight Loss

Unfortunately, some patients experience more severe side effects from taking Depakote. For example, some patients complain of liver damage or inflammation of the pancreas. Both of these side effects can prove to be life-threatening.

Other reported side effects include worsening depression and suicidal thoughts. In addition, children whose mothers took Depakote while pregnant may have had a greater risk of specific birth defects.

Some of the birth injuries babies of women taking Depakote or Depakote ER experience include:

• Neural tube defects
• Spina bifida
• Cognitive impairment
• Autism

This is why, in 2013, the Food and Drug Administration (FDA) warned healthcare professionals and women that pregnant women should not use Depakote.

Some pregnant women take this medication to prevent migraine headaches. The FDA pointed to research showing that children whose mothers took Depakote while pregnant may have decreased IQs. As a result, the FDA required that drug manufacturers include strong warnings about taking the drug during pregnancy on Depakote's packaging.

Depakote Lawsuits

During the first half of 2013, more than three dozen plaintiffs filed suit against Abbott Laboratories Inc., the manufacturer of Depakote, by the minor children of women who took the drug while pregnant or by the families or guardians of those children. The plaintiffs claimed they suffered severe injuries, including spina bifida and heart defects, from exposure to Depakote before birth.

Many Depakote congenital disability lawsuits allege that Abbott Laboratories failed to warn doctors and patients about the risks associated with Depakote. As of 2017 more than 650 Dekapote lawsuits have been filed.

Abbott Laboratories' Guilty Plea

Abbott Laboratories faced both civil and criminal allegations. The Department of Justice (DOJ) investigated Abbott Laboratories' alleged misbranding of Depakote. The DOJ claimed the company had illegally promoted Depakote for uses the FDA hadn't approved.

In May 2012, Abbott Laboratories pleaded guilty to a criminal misdemeanor for misbranding Depakote. The company also agreed to settle the government's criminal and civil claims for $1.5 billion.

Does Depakote Have a Black Box Warning?

A black box warning, also known as a boxed warning, is the most stringent type of warning the FDA issues. Depending on the circumstances, the FDA can order a drug manufacturer to include a black box warning on their packaging. The warning signifies that a product has a substantial risk of a severe reaction that can lead to death or disability.

Depakote carries a black box warning regarding the potential congenital disabilities discussed above. In addition, Depakote has a boxed warning related to the risk of pancreatitis, an inflammation in the pancreas that causes painful bleeding. Pancreatitis can lead to death if left untreated.

Patient reports of pancreatitis varied. Some patients reported experiencing it after initial use, while others did not report the complication until after years of using this antiepileptic drug.

How Dangerous Is Depakote for Pregnant Women?

The FDA classifies Depakote as an "X" for pregnant mothers. An "X" is the worst possible grade a drug can have because it signifies that the risks of using the medicine substantially outweigh any potential benefits.

According to the FDA, only pregnant women with severe seizure disorders or bipolar disorder should consider taking Depakote.

Are You Entitled to Compensation?

You may recover damages if you or your child suffered an injury after taking Depakote. It depends on several factors, including the following:

• How long you took the medication
• Whether you took the drug while pregnant
• Injuries sustained by you or your child
• Whether your product liability attorney can prove that the medicine is responsible for your injuries

If you prevail in your legal claim, you may recover some or all of the following types of damages:

• Medical expenses
• Future medical bills
• Lost wages
• Lost future income
• Pain and suffering
• Emotional distress

To receive any compensation, you must be able to prove liability. It isn't enough that you took the drug and became sick. You must prove causation. An experienced product liability attorney can help you do this.

Get Legal Help With Your Depakote Claim

If you or a family member has taken Depakote and had a child who suffered birth injuries or defects as a result, you may have a claim for damages. Acting sooner rather than later will help protect your legal rights. It will also allow you to recover fair compensation for your family's injuries.

Get started today by contacting an experienced product liability attorney near you.