Texas Depakote Lawyer – Texas Spina Bifida Lawsuit – Birth Defect Lawsuit
If you or a loved one had a baby born with birth defects after taking the medication Depakote you may be entitled to financial compensation from the manufacturer. Call us today to get the facts. Toll Free 1-866-777-2557 or use our online contact form and a Texas Spina Bifida Lawyer will get back to you within 24 hours to answer your questions and discuss your possible claim. This is a free, no obligation case review and there are no legal fees unless you receive money at the end of the case. Time is limited, so please call today.
Texas Depakote Lawsuit
Depakote a brand name anticonvulsant, with valproic acid as an active ingredient. This active ingredient is also a major part of other brands, including Stavzor, Valproic, and Depakene.
Depakote is used to treat seizures and bipolar disorder. It can also be prescribed to treat migraine headaches as well. The FDA has approved each of these uses over time, but only for individuals over certain ages, depending on the particular use. It works by increasing the gamma-aminobutyric acid (GAMA) quantities in the brain to level out mood and generally help with stability.
Depakote Side Effects
The most common side effects associated with Depakote are relatively mild. They include:
- Slower mental processes
- Hair loss
- Weight gain
It has also been shown to produce serious side effects as well. It can cause suicidal thoughts or tendencies. It can also cause life-threatening damage, including liver problems and pancreatitis.
Depakote has “black box” warnings for both liver failure and pancreatitis. FDA issues black box warnings as their most severe form of warning on a drug. These warnings indicate that there is significant or reasonable evidence that a certain serious or life-threatening condition is associated with taking a particular drug.
Unique Side Effects for Women
Women who take Depakote are put at some additional, unique risks. They are more likely to develop polycystic ovarian syndrome, which causes ovarian cysts and can inhibit a woman’s ability to become pregnant.
Some research indicates a connection to birth defects in pregnant mothers as well. These birth defects can be serious or life-threatening. They include:
- Lower intelligence
- Cleft palate
- Malformed limbs, brain, or skull
- Extra fingers or toes
- Heart defects
- Spina bifida
Because of the increased risk of birth defects, the FDA has included additional warnings on Depakote packaging that specifically warns expecting mothers of the increased risk of spina bifida. It generally should not be taken during pregnancy, if possible. The FDA has determined it is a Class D drug, which means that women should only take it while pregnant if there are no other options to treat a specific ailment.
In 2012, Abbott Laboratories, makers of Depakote, agreed to pay $1.6 billion in fines related to civil and criminal promotion of unapproved uses of Depakote. The company was allegedly marketing Depakote for off-label use in elderly patients who have dementia, downplaying the risks associated with the drug.
Clinical testing for use in the elderly indicated an unsafe increase in drowsiness, anorexia, and dehydration, forcing the company to discontinue the trials. However, sales teams continued to promote the drug for use in the elderly. The fines came after a four-year investigation into the issue.
In addition to the fines, there have also been several lawsuits asserted based on the birth defects caused by the drug.