Depakote and similar drugs that are used to treat epilepsy have been linked to higher risks of malformations and birth defects, such as deformed limbs and skulls, spina bifida, and oral clefts.
Lawyers specializing in product liability are researching the possibility of filing birth defect lawsuits involving Depakote on behalf of women who used the prescription medication and related generic forms while they were pregnant and gave birth to children who were born with malformations or additional problems.
Abbot Laboratories is the manufacturer of Depakote, and the FDA approved the generic valproic acid as an anti-seizure drug designed to treat epilepsy. Depakote is one of a class of drugs created from or involving valproate; additional examples of valproate based drugs include Stavzor, Depakene, and Depacon. The first of these drugs to be approved in the class of valproate based drugs was Depakene, which first obtained FDA approval in 1978.
Valporoic acid, which is also known as Valproate, is a mood stabilizing and anticonvulsant drug. Beyond being prescribed to treat epilepsy, many physicians also prescribe Valproate for the treatment of both depression and bipolar disorder.
The FDA added a warning on the packaging of Depakote in 2006. Known as a "black box" warning, this label warned women about the potential risks they faced of delivering children with birth defects if they used Depakote while they were pregnant. The warning was placed on the packaging after a research study published results indicating that 20% of deliveries from women who had been pregnant while using Depakote led to children who were born with birth defects.
Researchers also discovered in May 2010 that side effects and birth defects caused by use of Depakote while pregnant could result from use of the drug in any trimester, including the first. In other words, by the time a woman who is pregnant discovers she is pregnant, she might no longer have time to stop using the drug and subsequently prevent the development of birth defects in the growing fetus.
Researchers have found that use of Depakote during a woman's pregnancy may be linked to the following observed birth defects:
The most common birth defect that is associated with use of Depakote during pregnancy is spina bifida. Researchers have discovered that women who are pregnant and consume Depakote have a 12-fold increase in their likelihood of delivering a child who suffers from spina bifida than women who do not use Depakote.
As a result, the FDA strengthened the wording of the birth defect warnings on packaging for Depakote and similar drugs based on valproic acid in December 2009. The FDA informed health care professionals to warn all women who were of age to bear children and who were currently taking these drugs that use while pregnant could result in a wide range of birth defects in their children.
Depakote has also been found to cause potentially life-threatening liver failure in children under the age of 2. Children who consume more than one medication for seizures may be at even higher levels of risk for liver problems. Similarly, children who have metabolic disorders or mental impairment resulting from brain diseases (for example, multiple sclerosis) may also face increased risk for liver problems.