Depakote is a prescription drug used to treat several types of mood and seizure disorders. It is also used to help prevent migraines. Depakote received 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 benefited from Depakote use, it caused significant danger for some users. Patients experienced side effects such as pancreatitis, liver toxicity, and birth defects in babies whose mothers took Depakote during pregnancy. The manufacturer, Abbott Laboratories, faces numerous 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
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 have also been reported as less severe side effects. Dangerous side effects 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. Additionally, serious birth defects have been reported from women taking Depakote during pregnancy. The FDA has classified Depakote into pregnancy category D. This means that Depakote is proven to cause harm to fetuses and should be avoided during pregnancy.
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 incapacities, such as autism
Depakote FDA Warnings
The FDA released several advisories for Depakote users and the general public. The FDA 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 that surrounds 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 wen 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 has faced 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.