Depakote has been a popular treatment for epilepsy since hitting the market in 1983. Millions have taken the prescription drug to manage seizures. But the U.S. Food and Drug Administration (FDA) recently took action to caution doctors about prescribing the drug to pregnant women. In fact, concerns over inadequate warnings about potential birth defects have landed Depakote’s maker, Abbot Laboratories, in legal trouble.
Depakote is also known as valproic acid or divalproex sodium. It belongs to a class of drugs called anticonvulsants. These drugs help manage brain activity and are often prescribed to treat conditions like epilepsy, migraines and bipolar disorder. Depakote is sometimes prescribed for other conditions such as attention deficit hyperactivity disorder (ADHD) and chorea (hyperactive movement disorder). But the drug has been linked to serious side effects.
Potential birth defects from taking Depakote during pregnancy include:
- Cleft palate.
- Neural tube defects.
- Heart defects.
- Spina bifida.
- Hypoplasia (underdevelopment).
Dangers and Side Effects of Depakote
News of potential dangers associated with Depakote emerged from various sources over the years. For example:
- In 2006, the FDA added a black-box warning over potential birth defects. The warning followed a study reporting incidents of birth defects in 20 percent of women who gave birth while taking Depakote.
- In 2009, the FDA specifically warned about potential neural tube defects, heart defects and craniofacial birth defects. It also warned about suicidal thoughts and actions associated with Depakote use.
- In a 2010 study published in the New England Journal of Medicine, European researchers reported an increased risk of six different birth defects when Depakote is taken during the first trimester. The risk for spina bifada, in particular, increased 12 times for mothers who were prescribed the drug.
- In 2011, the FDA warned about a potential link between Depakote and decreased cognitive functioning. Studies have shown that, compared with children of women who did not take the drug, children born to mothers who took Depakote during pregnancy tended to score lower on IQ and other cognitive tests.
However, this news came too late for many women who took Depakote. After decades on the market, women and their health care providers were not adequately warned about the drug’s risks. Drugmakers have an ongoing duty to test the safety of their drugs and warn the public and health care providers about the risks. An adequate warning was particularly important for Depakote patients because birth defect risks increase as early as the first trimester, when women may not realize they are pregnant.
With adequate warnings from the drugmaker, women and their health care providers could have opted for less risky treatments or more effective birth control. That is why many families are filing legal claims against Abbott Laboratories for their babies’ injuries.
Filing a Depakote Claim
In July 2012, 27 mothers filed Depakote claims against Abbott Laboratories in an Illinois federal court. They are among an increasing group of women across the nation who have sued the drugmaker over birth defects.
The lawsuits are only the latest Depakote legal troubles for Abbott. In May 2012, the company reached a $3 million settlement with Arkansas for marketing the drug for unapproved uses, including schizophrenia and autism. The company also pleaded guilty to federal charges that it improperly promoted the drug to elderly dementia patients in nursing homes. It reached an agreement with the Department of Justice to settle the investigation for $1.5 billion in May 2012.
If you took Depakote during pregnancy and your child experienced birth defects, you may be able to join those holding the drugmaker accountable for improper marketing and warnings. You may be eligible for damages, including the costs of medical care for your child’s injuries and your family’s pain and suffering.
However, the law limits the amount of time available to file a claim, so consider speaking to a prescription drug attorney about your potential claim today.