What Is Depakote?
Depakote (divalproex sodium) is an antiepileptic drug used to treat seizure disorders, bipolar disorder, and other neurologic conditions, including migraine headaches.
How Does Depakote Work?
Depakote 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.
Who Manufactures Depakote?
Depakote is a brand-name antiepileptic drug containing divalproex sodium, manufactured by AbbVie, an American pharmaceutical company headquartered in Chicago, Illinois. The company was founded in 2012 when Abbott Laboratories separated into two separate companies, spinning off its entire pharmaceutical research division into another company, AbbVie. AbbVie is now one of the top ten biomedical companies in the world by revenue.
When Was Depakote Approved by the FDA?
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 migraine prevention in 1996.
What Does Depakote Treat?
Depakote was developed to treat neurological disorders and has been prescribed to treat a number of conditions, including epilepsy, bipolar disorder and migraines.
What Is Epilepsy?
Epilepsy is a disorder in the brain that causes recurring seizures. There may or may not be a known cause of epilepsy in a particular person. It’s a very common disorder and may affect as many as 1 in every 26 people. Epilepsy can affect anyone of any race, gender, or age. The brain disorder is typically diagnosed after someone has had two or more seizures within the span of 24 hours. One seizure alone doesn’t necessarily indicate epilepsy.
What Are the Symptoms of Epilepsy?
The symptoms of epilepsy can include the following:
- Loss of consciousness
- Loss of awareness
- Deja vu
- Staring spells
- Stiff muscles
- Uncontrollable jerking motions, particularly in the:
- Temporary confusion
- Behavior changes
While the symptoms of epilepsy vary per person, each individual with epilepsy will most likely experience each seizure the same way, with symptoms staying similar each time. Some may also experience warning signs that a seizure is imminent, such as visual auras or a feeling in the stomach. These are known as “prodromal” symptoms.
What Causes Epilepsy?
In some cases, doctors can pinpoint a specific cause of epilepsy, while in other cases, the cause may be completely unknown.
Some possible causes of epilepsy may include:
- Brain tumors
- Head trauma
- Developmental disorders
- Pre-birth injury
- Drug or medication use
Dementia, stroke, and other vascular diseases can increase the risk of developing epilepsy, which is more common in children and older adults. Children may have seizures due to high or rapidly changing fever, although that doesn’t necessarily indicate epilepsy.
What Complications Can Epilepsy Cause?
It is important to obtain adequate treatment of epilepsy due to risk of complications which may include:
- Sleeping problems
- Car accidents
- Memory issues
- Pregnancy complications
- Suicidal thoughts
- Suicidal behaviors
- Status epilepticus
- SUDEP (sudden unexpected death in epilepsy)
What Is Bipolar Disorder?
Bipolar disorder is a condition that affects mental health. In the past, the condition was called manic depression because it involved extreme mood swings from lows (depression) to highs (manic episodes). Bipolar is a lifelong condition and mood swing episodes can last as little as a few days but in many people, may last for months if untreated.
A treatment plan can help those suffering from the condition manage their symptoms and mood swings. Untreated bipolar disorder may affect:
- Clear thinking
What Are the Types of Bipolar Disorder?
There are several different types of bipolar disorder, classified not by severity but instead by what the different episodes and mood swings are like.
What Is Bipolar I Disorder?
Bipolar I Disorder may be diagnosed after at least one manic episode, which was either preceded or followed by a major depressive or hypomanic episode. The manic episode may cause psychosis in some cases.
What Is Bipolar II Disorder?
Bipolar II disorder may be diagnosed after at least one of each a hypomanic episode and a major depressive episode. Despite the II in its name, bipolar II disorder isn’t just a more severe version of bipolar I disorder. Bipolar II disorder is characterized by more severe depressive episodes, while bipolar I disorder usually involves more severe manic episodes.
What Is Cyclothymic Disorder?
Cyclothymic disorder is a type of bipolar disorder in which mood swings are less severe. People may be diagnosed with cyclothymic disorder after they have experienced at least two years of mood swings, which included many periods of both hypomania and depression. In most cases, there have been no severe manic or major depressive episodes in a person with cyclothymia.
What Are the Symptoms of Bipolar Disorder?
The symptoms of bipolar are very different depending on which type of episode is in process.
What Are the Symptoms of Manic and Hypomanic Episodes?
While hypomanic and manic episodes differ in severity from each other, they have similar symptoms, which may include the following:
- Racing thoughts
- Easily distracted
- Making poor decisions
- Abnormally talkative
- Unusually upbeat
- Increased levels of activity
- More energy
- Needing less sleep
What Are the Symptoms of Depressive and Major Depressive Episodes?
Similarly to mania and hypomania, depressive and major depressive episodes may have different severity, but they have similar symptoms:
- Loss of interest or pleasure
- Depressed mood
- Weight loss or gain
- Slowed behavior
- Sleeping too much or too little
- Loss of energy
- Feeling guilty
- Feeling worthless
- Difficulty thinking or concentrating
- Thoughts or plans of suicide
What Can Cause Bipolar Disorder?
While the exact cause of bipolar disorder isn’t known, there are several factors may play a role, including:
- Biological differences in the brain
- Traumatic event
- Drug or alcohol abuse
What Is a Migraine?
A migraine is a type of headache that involves severe pain, usually on one side of the head, that causes a pulsing or throbbing sensation. Migraines may also be accompanied by other symptoms, such as nausea or light sensitivity. The pain may last for days and can interfere with daily activities and living your normal life. Some people may see auras as a prodromal or warning sign that a migraine is coming. Migraines can affect anyone, including children and teenagers as well as adults. Depending on the severity and frequency, medications may be prescribed to treat the migraines.
What Are the Symptoms of a Migraine?
There are four different stages of a migraine, each with its own distinct symptoms. Not everyone who gets migraines will progress through all four stages, however.
What Is the Prodrome Stage?
The prodrome stage is a warning stage. It may begin a day or so before the migraine actually starts and may involve the following symptoms:
- Mood changes
- Stiffness in the neck
- Food cravings
- Yawning frequently
- Fluid retention
- Needing to urinate frequently
What Is the Aura Stage?
A second stage is the aura stage, which may occur either before or during the migraine itself. Auras are typically visual but can involve other symptoms as well. The aura phase may start mildly and then builds up gradually over the course of a period of several minutes up to an hour.
Aura symptoms may include:
- Seeing shapes
- Seeing bright spots
- Seeing flashes of light
- Vision loss
- Feeling pins and needles in an arm or leg
- Trouble speaking
- Weakness in the face
- Numbness in the face
- Weakness on one side of the body
- Numbness on one side of the body
What Is the Attack Stage?
The attack stage is the stage that involves the headache pain itself. If untreated, the attack stage could last anywhere between 4 and 72 hours.
The symptoms of the migraine attack stage may include:
- Throbbing or pulsing pain
- Pain on one side of the head
- Less commonly, pain can occur on both sides
- Sensitivity to light
- Sensitivity to sound
- Less commonly, sensitivity to touch and smell
What Is the Post-Drome Stage?
The post-drome stage occurs after the migraine attack is over.
After the pain has receded, you may feel the following:
- Washed out
These feelings may last for up to a day following the migraine attack. During this stage, sudden head movements might briefly bring back the pain.
What Causes a Migraine?
It’s not known exactly what causes a migraine, but certain factors may trigger a migraine, including:
- Hormonal changes
- Physical exertion
- Strong smells
- Bright, flashing lights
- Loud noises
- Too little or too much sleep
- Skipping meals
- Salty, processed foods
- Aged cheeses
- Changes in the weather
- Atmospheric pressure changes
- Food additives, like sweeteners
- Certain medications
The following factors may also increase the risk of getting migraines:
- Younger age
- Being female
What Are the Side Effects of Depakote?
While the drug has helped millions, there are a number of reported Depakote side effects. Depakote side effects may range from mild to serious and in severe cases, may be life-threatening.
What Are the Common Side Effects of Depakote?
The most commonly reported Depakote side effect is lethargy.
Other side effects may 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
What Are Depakote’s Links to 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 if at all possible.
Birth defects linked to Depakote 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
What Are Neural Tube Defects?
Fetuses with neural tube defects can 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.
What Is 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.”
What Is 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. Sometimes, 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.
What Are Cleft Lip and Cleft Palate?
Evidence shows that Depakote can cause cleft lip and palate in developing children. Cleft lip and cleft palate may occur separately or together. A 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.
A cleft palate occurs when the palate, or roof of the mouth, fails to fuse together properly. 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.
What Are Depakote’s Links to 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.
What Are Depakote’s Links to 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 of taking Depakote. It is recommended that blood testing is periodically performed to monitor the patient’s liver function.
What Is Hepatotoxicity?
Hepatotoxicity is another word for liver damage.
The symptoms of hepatotoxicity can include:
- Nausea and vomiting
- Weakness and lethargy
- Facial edema, or swelling
- Malaise, or a general feeling of illness
What Is Pancreatitis?
Pancreatitis is the inflammation of the pancreas.
The symptoms can include:
- Nausea and vomiting
- Loss of appetite
- Upper abdominal pain
- Tenderness in the abdomen
What Are Depakote’s Links to Suicide?
Depakote may increase the risk of suicidal thoughts and behaviors. The risk of suicide may be worse 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 suicidality.
Has the FDA Issued a Depakote Warning?
Over the lifespan of the drug, the FDA has released several advisories for medical professionals and Depakote users. 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. Starting in 2006, the FDA required black box warnings regarding Depakote’s risk of birth defects if taken during pregnancy, as well as the risks of hepatoxicity and pancreatitis.
These three black box warnings are required by the FDA to be placed inside the Depakote packaging with a black box surrounding the text.
Why Are People Filing Depakote Lawsuits?
AbbVie has faced a number of lawsuits for different reasons, including illegally marketing the medication to children and to seniors. The FDA hadn’t approved Depakote for use by either of those age groups. 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.
Other 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 by Depakote. Many patients claimed that they would not have taken the drug if they had been informed of the risks.
What Depakote Lawsuit Settlements Have There Been?
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 from dementia. However, Depakote only received FDA approval for the 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.
Later cases ended in a mix of results. In 2015, there was a $38 million verdict for the adoptive family of a girl whose birth mother’s use of Depakote during pregnancy was linked to her spina bifida. Another case in 2017 saw $15 million awarded to the mother of a child with severe enough birth defects that required that he use a wheelchair. Other cases in that same span of time were found for the defendant, the jury believing that the plaintiffs were aware enough of the risks despite their lawsuits claiming otherwise.
What Depakote Lawsuits Are There?
In 2018, there were hundreds of cases against AbbVie filed for a failure to warn of the risks of birth defects. These cases were put on hold that year in order to allow more time for complex settlement negotiations to occur. There have been no reported developments regarding these cases since 2022.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.