The anti-seizure drug Depakote works by increasing the amount of a special neurotransmitter in the brain. However, some women who took it while pregnant had babies born with severe birth defects.
Depakote, which is also known as divalproex sodium and valproic acid, is used to treat a variety of seizure and mood disorders, and to prevent migraines. Unfortunately, the anticonvulsant medication has been linked to suicide, liver toxicity, pancreatitis and a variety of birth defects, including cardiovascular malformations, neural tube defects and facial deformities.
The U.S. Food and Drug Administration (FDA) approved Depakote in 1983 for epilepsy treatment, in 1995 for bipolar disorder and in 1996 for the prevention of migraine headaches. Sold by Abbott Laboratories, the drug comes in a variety of forms: Depacon injections (valproate sodium), Depakote, Depakote CP and Depakote ER (divalproex sodium) and Depakene and Stavzor (valproic acid). The liquid form, Depacon, is less popular as it tends to make users nauseous.
Depakote has been approved for use in adults and children 10 and older for seizure treatment and age 16 and older for migraine prevention. It is not approved to treat bipolar conditions in children, although it has been known to be used in this off-label manner. In 2008, the FDA approved the first generic version of Depakote.
In recent years, Abbott Laboratories has faced federal charges of illegal marketing of Depakote to pediatric and geriatric patients. The drug company paid $1.6 billion to settle the charges. In addition, the company is facing personal injury lawsuits filed by families who have had a child born with birth defects after Depakote use during pregnancy.
Depakote works by increasing the amount of the neurotransmitter gamma amminobutyric acid (GABA) in the brain. GABA carries messages between brain cells and soothes overstimulated nerves. Depakote is used to treat epilepsy, a brain disorder that causes recurring but brief changes to the brain’s electrical system called seizures. Increasing the amount of GABA helps prevent brain signals that lead to seizures. Depakote may be prescribed either alone or in combination with other medications to treat epilepsy for those with complex partial seizures, and simple and complex absence seizures — all of which are characterized by impaired consciousness.
Commonly referred to as a mood stabilizer, Depakote treats bipolar manic episodes, which are marked by abnormally elevated mood and energy levels, reckless behavior and making choices with little regard for safety. Manic episodes can cause mentally unstable persons to become a danger to themselves or later face the consequences of manic periods spent spending excessive amounts of money, intense hostility, acting on grandiose ideas or engaging in uncharacteristic sexual behavior. Experiencing lows during manic periods can lead to suicide. Doctors may choose a treatment plan that combines Depakote with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) to treat acute bipolar depressive episodes.
When Depakote was introduced for manic episodes, it was thought to be a medical breakthrough. At the time, there were few medications approved for the symptoms of mania. Many studies show that Depakote improves bipolar symptoms over the other leading medication, lithium.
Depakote is also used to lessen the recurrence of migraine headaches, which are severe, painful headaches that are associated with vomiting, increased light sensitivity and bodily numbness or tingling. Although researchers have not pinpointed what causes migraines, many believe it is caused by a mix of genetic and environmental factors. Patients who typically have two to three weekly migraine headaches or more than one disabling headache per month see the greatest benefit from the drug. The drug is taken before the onset of migraines.
Side Effects and Birth Defects
Depakote commonly causes tiredness and can also slow mental processes. In addition, patients may experience nausea, tremors, hair loss and weight gain. Women who take Depakote are more likely to develop polycystic ovarian syndrome (PCOS), which can cause ovarian cysts and affect the ability to get pregnant.
|Babies born to mothers who took Depakote are more likely to suffer from several birth defects, including:|
|Spina bifida and other neural tube defects (spinal cord or brain damage)||Malformed limbs, skull or brain|
|Extra fingers or toes (polydactyl)||Cleft palate (facial malformation)|
|Heart defects (including atrial septal defect)||Lower intelligence (including autism)|
Due to the large number of serious and possibly fatal side effects, the FDA has placed several warnings and advisories on Depakote.
The label carries black-box warnings for the following:
- Pancreatitis in children and adults
- Liver failure (hepatotoxicity)
- Birth defects, including spina bifida
The FDA classifies Depakote as a class D drug, which means it has been shown to cause harm to human fetuses and should only be taken during pregnancy if no other medications can be used to treat a condition.
In the past several years, Abbott Laboratories has been hit with several fines regarding Depakote. In May 2012, Abbott was ordered to pay $1.6 billion over the company’s illegal marketing of the drug. In the four-year investigation, the Justice Department found that Abbott violated federal FDA regulations and state and federal laws in marketing the drug to promote off-label uses, including schizophrenia, depression and anxiety.
In July 2012, 27 victims filed suit against Abbott in an Illinois federal court. The plaintiffs, all women, said they took Depakote early in their pregnancies to control migraines and epilepsy symptoms. They said their children were born with Depakote-induced birth defects, including developmental delays, spina bifida, cleft palate and bodily malformations.