Depakote

Depakote (divalproex sodium) is an antiepileptic drug used to treat seizure disorders, bipolar disorder and other neurologic conditions including migraine headaches. While many people may have benefitted from Depakote, others may have experienced severe or even life-threatening side effects. Manufacturer AbbVie has faced multiple Depakote lawsuits due to injury claims over the drug including serious side effects such as pancreatitis, birth defects, liver failure and in some cases, death.

What Is Depakote?

Depakote is the brand-name of anticonvulsant medication which is used to treat Epilepsy and Bipolar disorder and for the prevention of Migraine. It works by increasing levels of the brain neurotransmitter gamma aminobutyric acid (GABA). GABA’s function in the body is to carry brain cell messages and soothe overstimulated nerves.

Epilepsy is characterized by seizures, which are caused sporadic changes to the electrical system in the brain. Depakote increases GABA, which helps to prevent these electrical changes. Migraines and bipolar disorder may be affected in a similar manner.

Depakote is available in other forms, including:

  • Depakote CP and Depakote ER
  • Depacon injections, which contain valproate sodium
  • Depakene and Stavzor, which contain valproic acid

Depakote Lawsuits

Some patients who took Depakote, have suffered injuries from this medication and have filed Depakote lawsuits against AbbVie or predecessor company, Abbott Laboratories.

Patients experience serious side effects and complications such as:

  • Pancreatitis
  • liver toxicity
  • birth defects in babies whose mothers took Depakote during pregnancy

In addition to drug injury claims, in 2012, federal and state Depakote lawsuits forced Abbott Laboratories to pay more than a billion dollars in penalties for engaging in illegal Depakote marketing.

AbbVie has paid roughly $1.6 billion to settle lawsuits and charges over improper marketing.

Depakote Side Effects

Depakote got approval from the U.S. Food and Drug Administration (FDA) in 1983, when it was approved to treat epilepsy. In 1995, it received FDA-approval to be used for bipolar disorder, and Depakote was used for migraine prevention by 1996.

While the drug has helped millions, there are a number of reported Depakote side effects. Depakote side effects range from mild to serious and in severe cases, may be life-threatening.

Many Depakote patients experience sleepiness or the slowing of their mental processes. Nausea, hair loss, weight gain, and tremors also occur as less severe side effects. Dangerous side effects of Depakote include suicidal tendencies, pancreatitis, and liver damage.

Women taking Depakote should be particularly cautious, as they can develop polycystic ovarian syndrome (PCOS). PCOS causes cysts in the ovaries which can cause women to become infertile. Additionally, it is recommended that pregnant women do not take Depakote due to the significantly increased risk of birth defects.

Common Depakote Side Effects

The most common reported Depakote side effect is lethargy, or tiredness. The occurrence of lethargy is shown to vary depending on characteristics of the patient including patient’s age, weight, and dosage amount.

This Depakote side effect is most common in elderly patients. The manifestation of fatigue as a Depakote side effect can be seen in the patient’s acuity and mental processes. Elderly patients are also more likely to experience Depakote side effects such as anorexia and dehydration.

Other common Depakote side effects include:

  • Hair loss in roughly 10 percent of users
  • Weight gain in roughly 50 percent of users
  • Nausea, especially during the first month of treatment
  • Changes in menstrual cycles in females
  • Tremors, which can be worsened by caffeine and anxiety

Depakote Birth Defects

The FDA classifies Depakote into pregnancy category D. This means that Depakote is proven to cause harm to fetuses and that pregnant women should avoid taking it.

Birth defects from Depakote can include:

  • Malformations in the skull, brain, or limbs
  • Polydactyl, or extra toes or fingers
  • Facial malformations such as cleft palate
  • Heart defects, including atrial septal defect (ASD)
  • Mental issues, such as autism

The FDA addressed birth defect dangers in 2006 when they required the addition of a black box warning after research indicated that fetal abnormalities were discovered in 20 percent of pregnant Depakote users.  In 2009, the FDA released a more detailed warning of Depakote side effects. Specifically, it cited the possibility of heart, craniofacial, and neural tube defects in developing embryos. Suicidal thoughts and tendencies from Depakote use were also noted.

Additionally, alarming information from the New England Journal of Medicine was published in 2010. The study revealed that six specific birth defects occurred at a high rate when Depakote was consumed during the first trimester of pregnancy. Pregnant Depakote users saw a 12-fold increase in their children being born with spina bifida.

The FDA released another Depakote warning in 2012. When compared with the children of non-Depakote users, children who were exposed to Depakote in the womb typically scored lower in IQ tests and other measures of cognitive function.

Depakote Neural Tube Defects

Fetuses with neural tube defects suffer damage to the spine, spinal cord, or brain. Neural tube defects typically develop within the pregnancy’s first trimester. These defects may develop before the woman is even aware of the pregnancy. Neural tube defects are among the most common types of birth defects. They occur in roughly one in 1,000 U.S. live births.

Depakote birth defects such as neural tube defects can typically be diagnosed before birth. Lab and imaging tests can be used for diagnosis. Unfortunately, no cure exists for neural tube defects. Additionally, function loss and nerve damage present at birth are typically permanent. Anencephaly and spina bifida are the two most commonly-occurring neural tube defects.

Anencephaly

Anencephaly causes the majority of the brain and skull to remain underdeveloped. Anencephalic babies are typically stillborn or die shortly after birth due to the severity of the condition. the Greek translation of the work means “no brain.”

Spina Bifida

Spina bifida occurs when the spinal column fails to completely close before birth. This leaves the spinal cord exposed after the baby is born. In some cases, the opening is large enough for the spinal cord to protrude through the bone opening. In many cases, nerve damage causes leg paralysis in the newborn.

Depakote Heart Defects

Depakote birth defects affecting the heart are believed to be more likely when the drug is taken during the pregnancy’s first trimester. Common Depakote heart defects involve the heart’s interatrial septum. The interatrial septum is the tissue wall separating the left and right atria, or sides of the heart.

A comparison of studies indicates that infants exposed to Depakote are twice as likely to develop atrial septal defect (ASD). ASD abnormally enables blood to flow between the two atria, resulting in inadequate oxygenation to body and brain tissues.

Depakote Cleft Lip and Palate

Evidence shows that Depakote can also cause cleft lip and palate in developing children. Cleft lip and cleft palate may occur separately or together. Cleft lip occurs when the lip tissue fails to completely fuse together before birth. This results in an opening in the upper lip after birth.

Cleft palate occurs when the palate, or roof of the mouth, fails to properly fuse together. Cleft lip and palate can create difficulty with feeding and speaking. The conditions can cause hearing loss and fluid buildup in the middle ears, which can lead to frequent ear infections.

Depakote Suicide

Depakote may increase the risk of suicidal thoughts and behaviors. Risk of suicide may be exacerbated in patients who take Depakote for conditions such as bipolar disorder which already carries a higher-than-normal risk of suicide.

In 2008, the FDA analyzed nearly 200 trials of epileptic drugs including Depakote. Research suggested that these patients experienced nearly double the risk of suicidal propensity.

Depakote Organ Damage

Depakote side effects include damage to the liver and pancreas. In 2006, the FDA required that the drug’s label feature a black-box warning indicating an increased risk of pancreatitis and liver failure. Evidence suggests that hepatotoxicity most typically occurs within the patient’s first six months taking Depakote. It is recommended that blood testing is periodically performed to monitor the patient’s liver function.

Depakote side effects of hepatotoxicity may include:

  • Nausea and vomiting
  • Weakness and lethargy
  • Facial edema, or swelling
  • Malaise, or a general feeling of illness

Depakote side effects of pancreatitis may include:

  • Nausea and vomiting
  • Loss of appetite
  • Upper abdominal pain
  • Tenderness in the abdomen

Depakote FDA Warnings: Black Box Drug Labels

Over the lifespan of the drug, the FDA has released several advisories for Depakote users and the general public. The agency has also required the addition of several warnings on the product’s packaging to ensure that consumers are properly warned of the dangers of using Depakote.

In 2006, the FDA required a black box warning to be included on the Depakote product label. The black box warning emphasized the risks of birth defects when taken during pregnancy. In 2009, the FDA warned the public of the risks of neural tube defects, craniofacial defects, and heart defects in infants born to mother who took Depakote. In 2011, the FDA warned the public about the possibility of decreased cognitive functioning in children born to mothers who took Depakote during pregnancy.

There are currently three black-box warnings required to be placed inside the Depakote package insert. These warnings receive their name from the black box surrounding the text of the warning.

FDA black-box warnings for Depakote and its sister drugs warn against:

  • Hepatoxicity, or liver damage which can lead to liver failure and death
  • Teratogenicity, or birth defects when used by pregnant women
  • Pancreatitis, or inflammation of the pancreas that can be deadly

Depakote Illegal Marketing

In addition to a number of fines from the FDA, AbbVie (formerly Abbott Laboratories) has faces a number of lawsuits from Depakote patients who have been harmed by the drug but was also accused of improper marketing activities.

Abbott Laboratories was accused of illegal marketing of the drug to children and senior citizens, despite the lack of FDA-approval for these patients. Additionally, the company marketed Depakote to treat depression, anxiety, and schizophrenia. These conditions have not been approved by the FDA and though the drug may be used for off-label purposes, drug manufacturers are not allowed to market medications for unapproved conditions.

In 2012, Abbott Laboratories agreed to pay $1.6 billion for illegally marketing Depakote from 2001 to 2006. Of the total $1.6 billion sum, Abbott Laboratories will pay $800 million toward civil cases filed against it by state and federal authorities. Additionally, $700 million is for criminal penalties and $100 million will go toward states for consumer protection matters.

The company admitted that it built a “specialized sales force” to market the drug in nursing homes. Depakote was marketed as a sedative to control aggression and agitation in older patients who suffer dementia. However, Depakote only received FDA-approval for treatment of seizures, migraines, and mania from bipolar disorder. Depakote was also marketed with antipsychotic drugs for schizophrenia treatment. Clinical trials gave no evidence of efficacy on schizophrenia over the antipsychotic drugs.

Depakote Lawsuit Claims and Settlements

In 2012, 27 women who had taken Depakote during their pregnancy filed against Abbott Laboratories in Illinois federal court. In January 2013, a South Carolina man filed a Depakote lawsuit. He claimed that his spina bifida condition was caused from his mother taking Depakote while he was in the womb. By the time of the Abbott 2016 reorganization and name change, over 100 Depakote lawsuits had been filed and by 2018, at least 635 Depakote lawsuits were pending against AbbVie.

Depakote lawsuits focused on the claim that Depakote caused debilitating birth defects in pregnant women. Depakote lawsuits also alleged that the company failed to warn the public of the full extent of dangers associated with Depakote use and that Abbott Laboratories/AbbVie was negligent in their duty to protect the public from being harmed from Depakote. Many patients claimed that they would not have taken the drug if they had been informed of the risks.

After a number of bellwether lawsuits ended with mixed results both for and against Abbott/AbbVie, In June 2018, federal lawsuits were put on hold to allow for all parties to participate in settlement negotiation.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.