First approved in the 1980s, Depakote is a mood stabilizer and anti-epileptic that has been prescribed to millions of patients. Regulators have since linked the medication to birth defects, suicidal thoughts and organ damage. Depakote birth defects may be cardiovascular, skeletal, neural or physical. 


The Truth

Studies + Science

Regulation Recap

The Next Steps

Depakote can cause serious side effects, including life-altering birth defects.

Depakote has been linked to cardiac, spinal and neural defects in newborns.

The FDA categorizes Depokate as a class D pregnancy risk.

Resources for families injured by Depakote are available now.

The Truth

Depakote Birth Defects And Suicidal Thoughts Linked To Anti-Epileptic Seizure Medication

Depakote is an anticonvulsant used for the treatment of epilepsy, manic depression and migraines. Also known as divalproex sodium, Depakote is classified as an anti-epileptic drug (AED) and is available in various forms.

Manufactured by Abbott Laboratories and AbbVie Inc., Depakote has been prescribed to millions of patients since it was first approved in 1983. The drug brought in $1.3 billion in sales in 2008, according to WikiInvest.

Though Depakote has positively impacted patients, the drug has also been linked to suicidal thoughts and liver/pancreatic damage, along with a series of birth defects that includes autism, spina bifida and cleft palate.

Depakote’s Uses

The main ingredient in Depakote is valproic acid. Depakote treats a number of symptoms and disorders, including depression and mania. According to the manufacturer’s website, Depakote is prescribed for three conditions, including:

Epliepsy
Prevents Simple, complex absence and complex partial seizures
Bipolar Disorder
Treats manic episodes and mood swings
Migraine Headaches
Eases symptoms of migraines

Studies + Science

How Depakote Works

Seizures take place when abnormal brain activity causes a consciousness disturbance, convulsion or involuntary spasm. Depakote treats epilepsy and other neurological disorders by interacting with GABA proteins in the brain. The drug increases GAD and decreases GABA-T, which minimizes overactivity and calms the neurons.

Depakote is available in different forms, including immediate, delayed and extended release tablets.

Depakene®DepakoteDepakote ER®Stavzor®
  • Capsules (immediate release): 250 mg
  • Syrup: 250 mg/5mL
  • Tablets (delayed release): 125 mg, 250 mg, 500 mg
  • Sprinkle capsules (delayed release): 125 mg
  • Tablets (extended release): 250 mg, 500 mg
  • Capsules (delayed release): 125 mg, 250 mg, 500

Proper dosage in relation to a patient’s age and weight is important, as incorrect amounts of Depakote can result in fatigue, mental cloudiness or intensified side effects. The severity of Depakote side effects differs based on the dosage.

Depakote Side Effects

Some side effects linked to Depakote involve physical changes, such as weight gain and hair loss. Some of these are a side effect of valproic acid, which is a main ingredient in Depakote. Statistics show that nearly 10 percent of people taking Depakote develop hair loss, while 50 percent gain weight.

Other side effects, such as nausea, vomiting and dizziness, are also common. However, Depakote has been linked to more serious complications that impact overall quality of life.

Common Side Effects

  • Nausea
  • Vomiting
  • Dizziness
  • Double vision
  • Weight gain
  • Problems with walking or coordination
  • Headache
  • Weakness
  • Stomach pain
  • Diarrhea
  • Hair loss
  • Sleepiness
  • Tremors
  • Blurry vision
  • Appetite changes

Depakote Birth Defects

Depakote is extremely dangerous for pregnant women. Depakote birth defects that affect multiple areas of fetal development, including brain functioning, cardiovascular systems, bone structures and physical appearance.

Research shows that using Depakote while pregnant can increase the risk of birth defects from 1 in 1,500 to 1 in 20. Depakote has also been linked to polycystic ovarian syndrome (PCOS), a condition that causes fertility when cysts develop on the ovaries.

According to the North American Antiepileptic Drug Pregnancy Registry, women who take 1000mg of Depakote daily to treat epilepsy during the first trimester have a higher risk of having children with birth defects. Out of 149 pregnancies, 16 children, or 10.7 percent, were born with congenital malformations.

In addition, three children, or 2 percent, had neural tube defects. Six others had additional malformations. The Centers for Disease Control and Prevention have also published research linking AEDs and birth defects.

CardiacSpinal and SkullNeural and CognitivePhysical
  • Congenital malformations
  • Atrial septal defect (ASD)
  • Ventricular septal defect
  • Spina bifida
  • Craniosynostosis
  • Neural tube defects
  • Developmental delays
  • Autism
  • IQ damage
  • Cleft palate
  • Polydactyl
  • Hypospadias


Suicidal Thoughts

Depakote also treats manic depression, a condition defined by mood changes that include depressive lows to manic highs. Researchers have linked Depakote to an increased occurrence of suicidal thoughts or behavior in patients with epilepsy or manic depression.

A study published in the National Library of Medicine confirms that suicide is already common in patients with epilepsy, illustrating that epileptic patients are 5 times as likely to commit suicide than the general population. Treatment with Depakote may exacerbate the issues.

Another analysis, conducted by the FDA in 2008, included nearly 200 epileptic drug trials. The results showed that Depakote and other AEDs can increase the risk of suicidal thinking and behavior in 1 of 530 people. During the trial, four people committed suicide.

Organ Damage

Depakote has been linked to organ damage, particularly in the liver and pancreas. Symptoms of organ damage include fatigue, swelling, weakness, stomach pain, nausea, vomiting or changes in appetite.

The damage can be so severe that it leads to liver failure or the development of pancreatitis, which is characterized by pain and inflammation.

  • Hepatoxicity — liver damage that can cause failure and death
  • Pancreatitis — a potentially fatal inflammation of the pancreas

Regulation Recap

The Food and Drug Administration (FDA) approved Depakote for epilepsy in 1983. The drug was later approved to treat bipolar disorder in 1995 and expanded to treat migraines in 1996.

Depakote is unapproved for epileptic children under the age of 10. When used by elderly people, Depakote should be taken with caution.

Depakote is a class D drug, illustrating that it can harm unborn babies. The FDA asserts that pregnant women, depressed persons or people with liver issues are the most at risk.

Black Box Warning

——-WARNINGS AND PRECAUTIONS——-

Hepatotoxicity; monitor liver function tests (5.1)

Women of Childbearing Potential; weigh Depakote benefits of use during pregnancy against risk to the fetus (5.2)

Birth Defects; Depakote can cause fetal harm when taken during pregnancy (5.3)

Pancreatitis; Depakote should ordinarily be discontinued (5.4)

Suicidal behavior or ideation; Antiepileptic drugs, including Depakote, increase the risk of suicidal thoughts or behavior (5.6)

Thrombocytopenia; monitor platelet counts and coagulation tests (5.7)

Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy (5.5, 5.8, 5.9)

Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate (5.10) • Multi-organ hypersensitivity reaction; discontinue Depakote (5.11)

Somnolence in the elderly can occur. Depakote dosage should be increased slowly and with regular monitoring for fluid and nutritional intake (5.13)

Safety Communications

In 2008, the FDA released an alert about the risk of suicidal thoughts. The FDA has been working to better understand how suicide links to AEDs since issuing safety communications in 2008.

“The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications,” according to the FDA. “This observation suggests that the risk applies to all antiepileptic drugs used for any indication.”

In 2009, the FDA added a warning to Depakote concerning the danger of neural tube birth defects. The Black Box Warning warning indicates that taking Depakote while pregnant can lead to birth defects.
In 2011 and 2013, the FDA made additional safety communications indicating that prenatal Depakote exposure may affect cognitive development and intelligence quotients (IQs).

Manufacturer Lawsuits

In 2012, Depakote received attention for its slew of dangerous side effects. The U.S. Department of Justice and 45 states sued the makers of Depakote for promoting the drug for dementia and schizophrenia, two uses unapproved by the FDA.

Because of widespread illegal marketing, manufacturers of Depakote became the target of a class-action lawsuit. The lawsuit included 27 women had children born with Depakote birth defects. A court ordered the makers of Depakote pay $1.6 billion to settle the charges.

The Next Steps

Depakote comes with a number of serious side effects. Patients should be informed about the risks of taking Depakote to treat epilepsy, manic depression or migraines. Pregnant women should not take Depakote, especially during the first trimester, as Depakote birth defects can be severe and debilitating.

Connect with an advocate to learn more about assistance for problems associated with Depakote.