Depakote is a brand name for a drug called valproate semisodium, which is also called divalproex sodium or valproic acid. The medication is used to treat seizure disorders such as epilepsy. The medication is also prescribed to prevent migraine headaches.
Depakote was first approved for the treatment of epilepsy in 1983 and was subsequently approved to treat bipolar disorder in 1995. In 1996, the FDA also approved the use of the medication to prevent migraines. The drug can be injected or can be taken in liquid/oral form and is sold by Abbott Laboratories.
Unfortunately, the medication may do more than just prevent headaches or treat seizures and psychiatric disorders. The medication has been linked to serious side effects, including a significant increase in the risk of birth defects. The drug makers also promoted the use of the drug for off-label or unapproved uses, putting patients at risk.
If you or a loved one have been harmed by Depakote’s unexpected side effects or by the prescribed use of the medication for a condition it was not approved to treat, you may have a claim for compensation. An experienced product liability lawyer at Roberts & Roberts can help you make your case.
The Dangers of Depakote
Depakote works by increasing the amount of gamma aminobutyric acid (GABA) that the brain produces. GABA is a neurotransmitter that relays messages between brain cells and can calm nerves when they become over-stimulated.
When the brain experiences changes to its electrical system, this can cause seizures. Increasing the amount of GABA in the brain can calm the nerves and minimize or prevent seizures. Depakote’s ability to control and calm nerve transmissions can also reduce manic episodes among bipolar patients and can reduce the number of migraine headaches a person gets. The medication does not treat migraines but does reduce their frequency.
While the FDA has approved Depakote to treat these medical conditions, Abbott Laboratories also promoted the drug for the treatment of conditions that the medication had not been approved for. This is called “off-label use.”
According to the Justice Department, the company illegally marketed Depakote for the treatment of dementia, autism and schizophrenia. Illegal marketing campaigns began in 1998, and from 1998 to 2006, Abbott maintained a “specialized sales force” that was trained to market Depakote to nursing homes to control patients who were suffering from dementia and who were agitated. From 2001 to 2006, the company also aggressively marketed the drug as a treatment for schizophrenia.
This marketing was done despite the absence of testing showing that the medication was effective or safe in treating these conditions. This is a violation of U.S. laws, and Abbott Laboratories paid $1.6 billion to settle the case brought by the justice Department.
Patients who received this off-label medication were put at risk of dangerous side effects because they were prescribed a drug that wasn’t necessarily safe for them and that was not proven effective at treating their medical conditions.
These patients were not the only ones endangered by Depakote. Abbott Laboratories also allegedly failed to disclose to the public that the medication carried serious risks for all patients, even those taking the drug for conditions it was approved to treat.
Studies Link Depakote to Birth Defects and Other Side Effects
When Depakote was released, thousands of patients worldwide were prescribed the drug to treat their medical conditions. Reports of adverse side effects began coming in that patients had not been warned about.
By June 2010, researchers at the University of Groningen in the Netherlands had conducted a large-scale study of more than 98,000 pregnancies. The study revealed that when mothers were prescribed Depakote, the risk of spina bifida was more than 12 times greater.
The study results, which were published in the New England Journal of Medicine, also revealed that there were five other birth defects that were more likely to occur in women who were prescribed Depakote. The increased risk of babies developing these other birth defects varied between two and seven times greater. For example:
- Babies had double the risk of being born with an atrial septal defect, which is a heart condition.
- Babies had five times the risk of being born with a cleft palate.
- Babies had five times the risk of being born with hypospadias, a condition in which the opening of the urethra is on the underside and not on the end of the penis.
- Babies had seven times the risk of craniosynostosis, a condition in which the skull bones close too early.
- Babies had two times the risk of polydactyly, or being born with more than five fingers on a hand.
The increased risk of birth defects was thus very significant. Prompted by these and other studies, the FDA released a safety alert in May 2013 warning that pregnant women should not be given Depakote or similar drugs as a method of treating medical conditions.
The FDA’s safety alert was triggered by a new study showing that babies can be born with lower overall IQ scores as a result of their mothers taking Depakote during pregnancy. The FDA also changed the warning on Depakote from “D” to “X” to indicate that the risks to pregnant women and babies outweigh any potential benefits that could come from the medication.
The warnings on Depakote that the FDA requires are not only related to the potentially increased risk of birth defects but also alert patients to other side effects that Depakote can cause as well. In addition to the increased risk of birth defects and health problems among babies, Depakote has also been linked to:
- Pancreatitis in both children and adults.
- Liver failure.
- Hair loss.
- Double vision.
- Weight changes.
- Irregular heartbeat.
- Chest pain.
- Uncontrolled eye movement.
- Depression or suicidal thoughts.
Patients should be fully alerted to the risks of these side effects so they can make an informed choice about whether they wish to take this medication.
Patients who were unaware of the risk of birth defects, liver failure, pancreatitis or other side effects associated with Depakote may have a legal cause of action against the drug maker for releasing a dangerous drug on the market and failing to alert them to its potential side effects.
An experienced defective drug lawyer at Roberts & Roberts can review your claim and advise you about how best to proceed. For a free, confidential review of your claim, call us today at 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.