Depakote is an anticonvulsant and psychotropic prescription drug approved by the FDA in 1983. Also known as divalporex sodium, it is used to treat seizures, migraines, and mania caused by bipolar disorder. The drug is also prescribed as Depakote Extended Release and is the delivery system used to treat seizures.
Depakote is manufactured by Abbott Laboratories, an American pharmaceutical company. Valporic acid is the active ingredient in Depakote. It works by balancing naturally occurring transmitters in the brain.
The most common side effects of Depakote are birth defects. Pregnant women who were prescribed the drug report their children were born with various health problems. These include:
- Cleft Palate
- Neural Tube Defects
- Spina Bifida
- Heart Defects
- Learning Disabilities
- Low IQ
Other side effects linked to Depakote use include suicidal thoughts, liver damage, liver failure, pancreas inflammation, and pancreatitis.
Most of the lawsuits against the drug are seeking medical expenses, future loss of income, and pain and suffering. One lawsuit filed in Illinois claims that Abbott Laboratories was negligent in manufacturing and distributing a “defective drug”. The suit also claims that the manufacturer misled doctors about the potential risks of the drug.
Both state and federal parties have settled with Abbott Laboratories. The have been civil, criminal, and administrative consequences enforced on the manufacturer. Most of these consequences are related to off-label usage of Depakote. Abbot Laboratories has pled guilty to misbranding Depakote, actively promoting it as a treatment for agitation in elderly patients with dementia and as a treatment for schizophrenia. The FDA has approved none of these uses as uses for Depakote.
The Depakote manufacturer has also pled guilty to targeting nursing homes with these unapproved claims. Abbot Laboratories was ordered to pay a settlement. It was the second largest settlement ever made by a pharmaceutical company. The 2012 settlement totaled $1.6 billion. The figure was divided with $800 million going to repay federal and state governments who covered prescription costs in Medicaid or Medicare plans, $700 million for criminal penalties, and $100 million for consumer protection claims. The settlement also stipulated that the manufacturing company institutes a self-policing board within the company to control marketing and advertised uses of the drug.
Abbott Laboratories has since made an additional $9.5 million settlement with the State of Louisiana regarding off-label uses.
Depakote has not been recalled because it is still FDA approved for treating seizures, migraines, and mania; however the manufacturer must now include black box warnings on Depakote and cease all off-label marketing.
The FDA mandated black box warning contains a warning to patients of the risk of birth defects associated with Depakote. This mandate was enforced shortly after a study of women who took Depakote showed a 20 percent chance of having a child with birth defects.
If you are considering taking Depakote or any of its generic forms, ask your doctor for more information about the risks and benefits, especially if you are taking the drug for an off-label treatment or are planning to become pregnant.
If you or someone you know has been injured by Depakote or any of its generic forms, contact the Law Offices of John Michael Bailey right away. There may be a statute of limitations, so it is very important to get the process started. Consult with an attorney as soon as possible.