Some patients who took Depakote, a drug used to treat several types of seizures, migraines, and mood disorders, are suffering injuries from this medication. Many have chosen to file lawsuits to recover compensation for the Depakote injuries they sustained. If you are coping with side effects or if your child has birth defects caused by Depakote, read on for more information.
Depakote got approval from the U.S. Food and Drug Administration (FDA) in 1983, when it was originally used 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 many have benefitted from Depakote use, it caused serious danger for some users.
Patients experience side effects such as:
- liver toxicity
- birth defects in babies whose mothers took Depakote during pregnancy
The manufacturer, Abbott Laboratories, faces many lawsuits for Depakote. So far, the company has paid roughly $1.6 billion to settle charges.
What Is Depakote?
The active ingredient in Depakote is divalproex sodium. It works to increase 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. This soothing quality makes Depakote a suitable treatment for epilepsy.
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.
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 Side Effects
Depakote was first introduced in 1983 as a treatment for epilepsy. It received additional FDA approval to treat bipolar disorder and migraine headaches. While the drug has helped millions, there are a number of reported Depakote side effects. Depakote side effects range from mild to fatal. Additionally, it is recommended that pregnant women do not take Depakote due to the significantly increased risk of birth defects.
Mild 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. Lethargy varies based on the 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
Depakote (valproic acid) is an epilepsy treatment that has been on the U.S. market since 1983. It helps epileptic patients manage seizures. Additionally, it can treat other conditions such as migraines and bipolar disorder. Since it was released, Depakote has been prescribed to millions of patients. The anticonvulsant drug is manufactured by Abbott Laboratories.
Depakote has been linked to severe birth defects when taken during pregnancy. The New England Journal of Medicine published a 2010 study on the effects of Depakote on pregnancy. The study found increased risk for developing six types of Depakote birth defects. The highest risk of the six Depakote birth defects was seen for spina bifida. The rates of spina bifida in children increased 12 times for women who took Depakote while pregnant.
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 causes the majority of the brain and skull to remain underdeveloped. Anencephalic babies are typically stillborn or pass away shortly after birth due to the severity of the condition. the Greek translation of the work means “no brain.”
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 enables blood to flow between the two atria.
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 FDA Warnings
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.
Suicidal thoughts and tendencies are a devastating Depakote side effect. This state of mind is naturally exacerbated in patients who take Depakote for conditions such as bipolar disorder. These patients typically show preexisting extreme mood disorders caused by mental illness. 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. Hepatotoxicity, or chemical-induced liver damage, is a reported Depakote side effect. 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
Side effects from using Depakote range from minor to severe. 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. Women also report serious birth defects when taking Depakote during pregnancy.
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 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
Depakote FDA Warnings: Black Box Drug Labels
The FDA released several advisories for Depakote users and the general public. The agency 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.
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
In addition to a number of fines from the FDA, Abbott Laboratories faces a number of lawsuits from Depakote patients who have been harmed by the drug. Abbott Laboratories engaged in 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.
The company paid nearly $1.6 billion in 2012 for this illegal marketing. Abbott Laboratories also faces several lawsuits from Depakote users. In 2012, 27 women filed against Abbott Laboratories. These women had all taken Depakote during their pregnancy. They all allege that Depakote caused birth defects in their children. Depakote patients who wish to file a claim should seek an experienced attorney to discuss their options.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.