Q: What is Depakote?
Depakote is a medication used to treat seizures, psychiatric disorders, and severe migraines. Designed to restore the balance of natural chemicals in the brain called neurotransmitters, Depakote is manufactured by Abbott Laboratories as a brand name version of the generic drugs divalproex sodium and valproic acid. Depakote received Food and Drug Administration (FDA) approval for seizures in 1983, psychiatric disorders in 1995, and migraines in 1996.
Q: Is Depakote a selective serotonin reuptake inhibitor (SSRI)?
A selective serotonin reuptake inhibitor, or SSRI, is a type of antidepressant medication that works by increasing levels of serotonin, which is a brain chemical associated with feelings of self-confidence and happiness. Depakote, on the other hand, is classified as an anticonvulsant - a type of medication used to treat and prevent seizures caused by conditions such as epilepsy. Some anticonvulsants, like Depakote, are prescribed as mood stabilizers for the treatment of bipolar disorder. In some cases, doctors prescribe Depakote and an SSRI together. The SSRI treats a bipolar patient's depression while Depakote treats the symptoms of mania, including aggression and irritability.
Q: What health complications are associated with Depakote?
Just like any medicine, Depakote carries side effects. The most common health complications linked to Depakote are lethargy/sleepiness, diarrhea, nausea, abdominal discomfort, and hair loss. More severe complications have also been linked to the drug.
The FDA announced that some patients may experience an increased risk of suicidal thought and behavior while on anticonvulsant medications such as Depakote. The FDA held a clinical trial and found that patients receiving these antiepileptic drugs were twice as likely to have suicidal tendencies than patients receiving a placebo.
Birth defects are another set of possible complications associated with Depakote. The FDA has stated that Depakote carries a heightened risk of major malformations in infants, particularly neural tube defects. Neural tube defects are deformations in the brain and spine of an infant. One common neural tube defect is spina bifida, a condition that leaves the spinal cord exposed.
There have also been recent reports that Depakote may have a negative impact on children's cognitive abilities. The FDA referenced a Neurodevelopment Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproic acid products like Depakote while their mothers were pregnant had lower IQ scores than children who were exposed to other antiepileptic drugs. The difference in IQ scores between these two groups of children ranged from 8-11 points.
Q: Does Depakote have a black box warning?
A black box warning, also known as a boxed warning, is the most stringent type of warning issued by the FDA. Under certain circumstances, the FDA can require a black box warning to be included on the product's packaging. The warning signifies that a product has a substantial risk of a serious harmful reaction that can lead to death or disability.
Depakote carries a black box warning regarding the potential birth defects discussed above. In addition, Depakote carries a boxed warning related to the risk of pancreatitis, an inflammation in the pancreas that causes painful bleeding and may even lead to death if left untreated. Patient reports of pancreatitis are varied-some patients reported experiencing it after initial use while others did not report the complication until after years of usage.
Q: In which pregnancy risk category does the FDA classify Depakote?
The FDA classifies Depakote as an "X" for pregnant mothers. An "X" is the worst possible grade because it signifies that the risks of using the drug substantially outweigh any possible benefits. The FDA cautions that Depakote should never be prescribed for pregnant women for the treatment of migraines.
In addition, The FDA advises that Depakote should only be prescribed for pregnant women with seizures or bipolar disorder when other medications have proven ineffective. With regard to using Depakote to treat seizures and bipolar disorder, the FDA gave it a letter "D," indicating that the potential benefits of the drug may be acceptable despite the risks.
Q: Can Abbott Laboratories be held liable for Depakote complications?
Under product liability law, manufactures and sellers have a duty to ensure that their products are free from any unreasonable defects or dangers. A number of patients have filed lawsuits against Abbott Laboratories claiming injuries related to Depakote use. Many of these lawsuits have alleged that Depakote carried defective warnings, meaning the manufacturer failed to provide adequate information about the dangers associated with the drug.
How to Get a Legal Review of Your Depakote Claim
You can claim damages for injuries either or your child may have suffered as a result of taking Depakote. In some cases, evidence of injury -- such as learning disabilities in children -- may not be discovered until years after the mother's exposure to the drug. If you or your child have suffered from exposure to this or other dangerous drugs, have a qualified products liability attorney evaluate your claim absolutely free.