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Depakote: Side Effects, Black Box Warnings & Lawsuit Information

Depakote, prescribed for seizures, migraines and bipolar disorder, carries serious risks including liver failure, birth defects and suicidal thoughts. Plaintiffs filing lawsuits claim that AbbVie failed to properly warn patients about these risks. Learn about side effects, recalls and legal actions here.

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Key Takeaways on Depakote Risks and Lawsuits
  • Serious side effects include liver damage, pancreatitis, birth defects, cognitive risks, and suicidal thoughts and actions.
  • FDA black box warnings have been included for hepatotoxicity, pancreatitis and fetal harm.
  • Ongoing lawsuits against AbbVie alleging failure to warn, misleading promotion and birth defects.

What Is Depakote Prescribed For?

Depakote, the brand name for divalproex sodium, is commonly used to help with epilepsy, bipolar mania and migraines. Available in both brand and generic forms, this anticonvulsant is effective for many patients.

However, its serious potential side effects, especially concerning birth defects, have prompted FDA warnings and lawsuits against Depakote’s manufacturing company, AbbVie, Inc.

Common Depakote Side Effects

Common Depakote side effects include digestive issues, sleepiness, weight changes, low energy, tremors and hair loss.

Some side effects, such as nausea and vomiting, can be alleviated by starting with a lower dose and working to a higher one. Taking the medication with food may help as well.

Some common Depakote side effects include:

Digestive problems:
Patients may experience nausea, vomiting or diarrhea.
Drowsiness and sleepiness:
Depakote often causes drowsiness or lethargy.
Weight and appetite changes:
Both weight gain and loss are well-reported side effects, along with changes in appetite.

While less common, there is some evidence that valproic acid, one of the ingredients in Depakote, is associated with changes to libido, irregular menstrual cycles and impotence.

If you experience persistent or disruptive side effects while taking Depakote, you may want to contact your doctor.

Serious Risks and Injuries Linked to Depakote

Some of the serious risks and injuries that have been linked to Depakote include liver damage, pancreatitis, birth defects, developmental disorders and behavioral changes.

Liver Damage and Pancreatitis

Depakote carries a black box warning, the most severe type of warning on a drug label, for hepatotoxicity, meaning liver damage, with fatal liver failure typically happening within the first six months. This is particularly common in children under the age of two and those who have mitochondrial disorders. Pancreatitis, meaning an inflamed pancreas, can also occur.

Liver Damage From Depakote
Hyperammonemia
This condition occurs when there are elevated levels of ammonia in the blood, often because the liver did not filter it out correctly. Hyperammonemia can cause confusion, significant lethargy and coma. It typically occurs within a few weeks of starting Depakote or increasing its dose. However, some people with hyperammonemia are asymptomatic.
Acute Hepatocellular Injury
The liver damage appears 1 to 6 months after starting valproate. This condition is when liver cells, called hepatocytes, become damaged. It can cause jaundice and is also associated with microvesicular steatosis, a potentially fatal condition in which fat accumulates within liver cells. It is also associated with centrilobular necrosis, which is cell death within the liver.
Reye-like Syndrome
Particularly prevalent in children, this severe condition mimics Reye's syndrome with symptoms like fever, lethargy, confusion, stupor and coma, alongside high ammonia levels and significant ALT elevations. Viral infections like influenza or varicella are the common triggers in the presence of valproate. This syndrome can quickly turn fatal.

Birth Defects and Developmental Disorders

Depakote is a known human teratogen, meaning it can cause malformed embryos. When taken during pregnancy, it can increase the risk of birth defects like spina bifida.

Spina bifida is a condition in which the neural tube, which eventually helps form the central nervous system, doesn’t close properly. This can leave a gap in the spinal cord, which may result in back pain, leg paralysis or learning disabilities.

Suicidal Thoughts and Behavioral Changes

Depakote and similar anticonvulsants have been linked to increased risks of suicidal thoughts. In clinical trials of antiepileptic drugs, about 1 in every 530 patients taking anticonvulsants had suicidal ideation.

Long-Term Cognitive Impairment

Babies born after being exposed to Depakote in the womb may experience lower IQ rates and developmental disorders.

FDA Actions for Depakote

The FDA’s biggest action regarding Depakote was a label change requirement, including black box warnings for fetal risk.

Although there have been no FDA-mandated recalls, the organization has determined that Depakote should not be used by pregnant individuals unless absolutely necessary.

Black Box Warnings for Depakote

Black box warnings represent the FDA’s most serious warning, signaling life-threatening or permanently disabling risks. The black box warnings for Depakote include:

  • Liver failure
  • Pancreatitis
  • Fetal risk, like birth defects

FDA Mandates & Label Changes

In response to research findings and reports of birth defects and cognitive decline, the FDA required strong warnings. Around 2006, Depakote’s labeling was updated to emphasize the risk of taking the drug for pregnant individuals.

The pregnancy category was then updated to Category X for migraine use, indicating that the risks outweigh the benefits. This means Depakote should not be used for migraine treatment in pregnant people.

Regarding severe cases of bipolar disorder or seizures, however, Depakote use during pregnancy is a Category D. This means the medication should only be used as a last resort for pregnant individuals who do not respond well to, or cannot take, alternative treatments for bipolar disorder or seizures.

Recalls or Shortages

No major recalls have been announced for Depakote. Label updates, not recalls, are the primary FDA interventions. Abbott Laboratories (now AbbVie) has faced FDA scrutiny, however, for labeling and promotion practices.

AbbVie has faced numerous Depakote lawsuits from individuals and families who allege that Depakote caused birth defects. They claim there was insufficient warning of the risks and misleading promotions.

Most suits are product liability claims, meaning failure to warn, design defect or misbranding. Some also cited aggressive marketing for unapproved (off-label) uses.

In 2012, Abbot Laboratories pleaded guilty in a lawsuit filed by the U.S. Department of Justice for “promoting [Depakote] to control behavioral disturbances in dementia patients and to treat schizophrenia when neither of these uses was approved by the FDA.”

In 2015, a St. Louis jury awarded $15 million in compensatory damages plus $23 million in punitive damages to a family whose daughter was born with spina bifida. Another widely reported case happened in 2017, and saw a California jury award $15 million for a boy who was born with a spinal condition due to Depakote exposure in utero.

New lawsuits continue to emerge, with early 2025 filings claiming birth defects, autism and ADHD linked to in-utero exposure. However, no major verdicts or settlements have been announced.

Depakote Manufacturer: AbbVie

AbbVie, spun off from Abbott Laboratories in 2013, inherited Depakote and the associated legal history. The company has faced continuous litigation and regulatory interactions around product safety and labeling. Depakote was one of its most profitable products, likely due in part to its aggressive marketing.

Depakote Case Study

Case Study: Baby Born With Birth Defects After Mother Was Prescribed Depakote

Court documents claim that Janija James, a resident of Toledo, Ohio, was born with multiple congenital malformations due to her mother’s ingestion of Depakote during the first trimester of pregnancy.

Drug Information

Legal documents claim that Abbott Laboratories, the makers of Depakote, promoted the drug as an effective anti-epileptic drug (AED). However, its main component, divalproex sodium, is known to cause serious birth defects if taken during pregnancy, especially during the first trimester when the embryo is undergoing critical development, according to the complaint.

Side Effects

Court documents say that medical research has found that Depakote can cause serious birth defects like spina bifida, cleft palate, limb and finger malformations, developmental delays, genitourinary issues and heart defects.

The documents also say that even though Depakote is effective for controlling seizures, it carries a higher risk of causing severe birth defects compared to other similar medications for pregnant women or those who may become pregnant.

Consequences

The complaint claims that because of her mother’s use of Depakote, Janija was born with leg deformities and other congenital malformations. Her mother claimed Janija will continue to face physical and mental impairments, requiring ongoing medical treatment and support.

Depakote Alternatives and Patient Safety

Many anticonvulsant medications carry similar risks. However, some antiepileptic drugs, such as Lamictal (lamotrigine) and Keppra (levetiracetam), may be safer for pregnant people.

Additionally, a study from the Journal of JAMA Neurology found that Depakote was associated with a 40% increased risk of death compared to other drugs for post-stroke epilepsy patients.

You should never stop Depakote or switch medications without guidance from your healthcare provider. Evaluating benefits and risks should always involve medical advice in plain, understandable terms.

When To Seek Medical Attention

It’s vital to know when to seek emergency medical attention while taking Depakote. You should not ignore the following symptoms that require immediate intervention.

Concerning Symptoms to Watch For
Signs of Liver Problems
Symptoms such as jaundice (yellowing of the skin or eyes), severe fatigue, abdominal pain (especially on the upper right side), dark urine and unusually pale stools require urgent medical evaluation.
Pancreatitis Symptoms
If you experience severe abdominal pain that may radiate to your back, nausea, vomiting and fever, these could be signs of pancreatitis.
Mental Status Changes
While taking Depakote or any seizure medication, watch for changes in mood or behavior. Seek immediate help if you experience new or worsening depression or anxiety.
Severe Allergic Reactions
Signs of a serious allergic reaction include difficulty breathing; swelling of the face, lips, tongue or throat and severe rash or hives.
Symptoms of Bleeding or Blood Clotting Disorders
Unexplained bruising, nosebleeds, bleeding gums or any signs of non-stop bleeding may indicate a serious blood disorder linked to valproate use.
Please seek the advice of a medical professional before making health care decisions.