Depakote is an anti-seizure or anti-convulsive drug used to treat epilepsy and other conditions. Abbott Laboratories is the maker and seller of Depakote, which also goes by the generic names valproic acid, valproate, and divalproex sodium. For treating people with seizure disorders, the U.S. Food and Drug Administration first approved treatment with Depakote in 1983. Later the agency would approve it for other uses as well.
While many people tolerate Depakote well and even rely on it to stay healthy, some people have suffered serious side effects that have caused lifelong damage and health problems. From birth defects to liver damage, the consequences of using this drug have been severe for too many patients. Lawsuits over these instances have led to accusations of illegal marketing and settlement money for some patients.
What is Depakote?
The original use for Depakote, or valproic acid, as it was developed by Abbott and approved in 1983 was to treat and prevent seizures in people with epilepsy and other seizure disorders. It can be used in adults and children over the age of ten. Depakote is generally the first treatment that doctors use in patient with seizure disorders.
Later, in the 1990s, the FDA approved Depakote for additional uses. It can be used to treat the manic phases of bipolar disorder, but only in adults. It can also be used in adults and teens over 16 to treat migraines and other types of chronic headaches. Although not approved for other uses, some doctors may give patients Depakote to treat impulse disorders and even bipolar disorder in children. This is considered risky because of potential side effects, but if a doctor thinks the benefits outweigh those risks, it may be prescribed.
Common Depakote Side Effects
The most common side effects that are reported by people taking Depakote are diarrhea, dizziness, nausea, weight gain, and drowsiness. None of these are typically serious, and may even disappear as the body gets used to the drug. Less common are side effects like confusion, disorientation and trouble thinking, hair loss, and a low platelet count and easy bruising. These rarer side effects are more serious.
Among the less common Depakote side effects that can be severe or potentially even life-threatening if not addressed is damage to certain organs. Some people on the drug may end up with liver or pancreas damage, either of which can cause lasting health problems if left untreated for too long. They can even lead to organ failure, which can be fatal.
Possible damage to the liver is serious enough with Depakote that the FDA has required that the medication packaging include a black box warning about it. The black box is reserved for the most severe and potentially fatal side effects of a drug. Liver failure caused by valproic acid has actually led to fatalities and the risk is higher when patients are taking it for at least six months and also in young children.
The potential damage to the pancreas is also a part of the black box warning, and is to be taken seriously. There is evidence that Depakote may lead to pancreatitis, or inflammation of the pancreas. Both children and adults are susceptible to this side effect. Some cases are acute pancreatitis, a form of the condition that starts and progresses quickly to a life-threatening state. Some patients developed this soon after starting Depakote while others didn’t see signs of pancreatitis until years after taking it.
In 2008 the FDA issued a warning that anti-seizure drugs, including Depakote, could increase the risk of suicidal thoughts and actions in patients taking them. The announcement also included the requirement that drug makers update medication labels to include a warning about this risk and submit a risk evaluation and mitigation safety guide to be given to patients and their families. With a risk of suicide it is important that both the patient and the people around them are aware of the signs of suicidal tendencies so they can intervene and report to a doctor for help.
The FDA’s warning came from an analysis of nearly 200 trials with anti-seizure drugs. The agency looked at all the data and found that patients taking any one of these medications had a doubled risk of suicidal thoughts. During the trials, four people taking a medication committed suicide, but none on a placebo did. Patients taking Depakote for bipolar disorder should be especially careful and watchful for signs of suicidal thinking and behaviors.
The black box warning on Depakote includes information about potential side effects for pregnant women taking the medication. There is solid evidence that it can cause birth defects in babies. The evidence is strong enough that the FDA required the black box warning, but also categorized Depakote as a class D in terms of pregnancy risk, meaning it has been shown to harm human fetus development.
Among the defects proven to be connected with Depakote are neural tube defects, which include damage to the brain or spinal cord. Babies of women who took Depakote while pregnant are also at risk for developing spina bifida, cleft palate, cleft lip, and heart defects. There are also possible developmental risks. Children of mothers who used the drug are more likely to score lower on IQ tests and to be diagnosed with an autism spectrum disorder. These are just a few of the potential pregnancy side effects that can occur and that can follow a child for life.
The evidence for these effects is strong. According to one report from the North American Antiepileptic Drug Pregnancy Registry, 16 out of 149 women using Depakote gave birth to children with some type of congenital defect. These women took 1,000 milligram doses during the first trimester. The Centers for Disease Control and Prevention states that women using Depakote during pregnancy have a 12 times greater risk of having a child born with spina bifida.
Side Effects of Discontinuing Depakote
Depakote also comes with side effects of not using it. It is never recommended to suddenly stop using the drug because doing so can cause a serious and life-threatening type of seizure. If a patient needs to stop using Depakote because of side effects, a doctor must guide that person through a process of slowly taking less and less in order to discontinue use safely.
Depakote Side Effects Lead to Lawsuits
There are so many potential side effects associated with Depakote and many of them are serious. This means that people have suffered and have sued the drug maker for what they believe was negligence. Judges and juries have agreed, and in some cases have awarded large settlements to plaintiffs, including one girl born with spina bifida. She won $23 million in her case.
Abbot, now AbbVie, has also had to pay $1.5 billion to the federal government over Depakote. The government found that the company illegally promoted the drug for off-label purposes. Doctors may prescribe drugs off-label, but it is illegal for a company to promote or market in this way to consumers or health professionals. If you were harmed by Depakote and feel that the drug maker was negligent, you may be able to make a case for receiving compensation.