Depakote, also known generically as divalproex sodium, valproic acid, or valproate, is an anti-seizure drug. It is used to prevent seizures in people with epilepsy, but can also be used for other conditions or symptoms, including bipolar disorder and migraines. Depakote is effective for many people, but can also cause side effects that range from mild to very serious. It is these serious side effects that have led to lawsuits against the makers of Depakote.
Abbott Laboratories has been making and selling Depakote in several different forms, from injections to liquids and tablets, but now is facing a number of lawsuits. The medication has been tied to serious birth defects, liver failure, and pancreatitis. The company has also been accused of using illegal marketing techniques. It has been forced to settle in some cases, while others are ongoing. If you have suffered devastating side effects from Depakote, you too may have a case against Abbott Laboratories.
Depakote for Epilepsy
As an anticonvulsant, Depakote is often used to treat epilepsy and was first approved for this purpose in 1983. It is approved for treating this condition in people aged ten and older only. Epilepsy is a brain disorder caused by misfiring in neurons in the brain. The result is seizures, characterized by muscle convulsions and spasms, strange emotions and sensations, and a loss of consciousness. Depakote is considered a first-line treatment for seizures and a number of types of seizure disorders and epilepsy.
Other Uses for Depakote
Depakote was also approved by the U.S. Food and Drug Administration (FDA) for the treatment of bipolar disorder and migraines, in 1995 and 1996, respectively. Bipolar disorder is a mental health condition characterized by cyclical mood swings from depression to mania. Depakote is specifically used to treat the manic episodes of bipolar disorder, but is not approved for this use in children. The FDA also approved Depakote to treat migraines, severe and chronic headaches, in people 16 years old and older. It treats these by preventing them. Off-label, a doctor may prescribe Depakote to treat impulse control disorders or to treat bipolar disorder in children.
How Depakote Works
Exactly how Depakote works to treat seizures, bipolar disorder, and migraines, is not fully understood, but it is thought to be related to a certain neurotransmitter. Neurotransmitters are chemicals used in the brain for signaling and sending messages between neurons. Depakote increases the amount of one of these neurotransmitters, called gamma amino-butyric acid, or GABA for short.
GABA is thought to relax nerves, which is why it acts like an anticonvulsant and why it may prevent migraines. It also may stabilize mood, reducing symptoms of mania in bipolar disorder. Depakote may act on GABA in two ways: stimulating the brain to produce more of it and inhibiting the process that normally breaks it down and destroys it.
The most common side effects of taking Depakote include diarrhea, nausea, drowsiness, dizziness, and weight gain. Rarer side effects are liver problems, hair loss, low platelet count (which can cause bruising), confusion, disorientation, and trouble thinking. Depakote may also cause a condition called pancreatitis, which is characterized by nausea and vomiting, severe stomach pain, and loss of appetite.
A very serious possible side effect of Depakote is an increase in suicidal thoughts. Research has been found that suicidal thoughts and actions are up to two times more common in people who have not taken Depakote or another similar anticonvulsant. Suicidal thoughts and behaviors have been reported in one out of 550 patients taking any anticonvulsant. Depakote has also been linked to birth defects and liver failure.
Black Box Warnings
Depakote carries three black box warnings. These are required by the FDA and represent the most serious and possibly life-threatening risks of taking a medication. Depakote’s black box warnings are for birth defects, pancreatitis, and liver failure. Depakote’s safety label includes information about each of these warnings. It states that liver failure, which has resulted in deaths, have been reported in patients taking the medication for at least six months. Children under the age of two are especially at risk of liver failure from Depakote use. Warning signs of liver failure include weakness, lethargy, anorexia, facial edema, and vomiting.
Birth defects that have been seen in the babies of women who took Depakote while pregnant include neural tube defects, like spina bifida, skull and face defects, heart defects, limb malformations, and others. Women who took Depakote have a four-time greater risk of having a baby with birth defects than those who did not. Another possible risk is that a child born to a mother taking Depakote may have a lower IQ. For these reasons, Depakote is not recommended for women who are or may become pregnant.
Pancreatitis, the swelling of the pancreas, has been reported in both adults and children taking Depakote. The cases include those that progressed rapidly from the first symptoms to death. Some instances of pancreatitis occurred after years of use of the drug, while others occurred after just initial use of Depakote. Nausea, vomiting, loss of appetite, and serious stomach pain are signs of pancreatitis.
Abbot Laboratories has faced and is still facing numerous lawsuits over these more serious and often life-threatening side effects of Depakote. The company has been accused of knowing about the risks without adequately communicating them and for marketing the drug illegally, knowing of the risks. One such lawsuit that is ongoing involves eight plaintiffs who blame their children’s birth defects on Depakote. The plaintiffs accuse the company of knowing about the possibility of birth defects, inadequately testing the drug, not properly warning patients and doctors of the risks, and knowingly misleading doctors.
Another lawsuit in 2015 awarded $23 million to a girl from Minnesota who was born with spina bifida caused by Depakote. The money was awarded as punitive damages against the drug company for its liability in her birth defect, although the company has stated it will appeal the verdict. In 2012 Abbott agreed to pay $1.5 billion in a settlement. The federal government accused the company of illegally promoting Depakote for uses not approved by the FDA.
Suits against Abbott and its spinoff company, AbbVie, are ongoing. If you have been hurt by Depakote, have a child with birth defects because of the drug, or you have lost a loved one to this medication, you too may have a case against the company. You may have a chance to file or join a lawsuit that could get you the monetary damages you need to recover from your illness or loss.