Use of Depakote during pregnancy has been linked to serious side effects in children. Infants born to mothers who use Depakote have shown a higher rate of birth defects when compared to other medications. Major complications in newborns include neural tube defects (such as spina bifida), craniofacial defects, and cardiovascular malformations.
In December 2009, the FDA advised that Depakote should not be prescribed to women of childbearing potential unless the drug is essential to managing a serious medical condition. For migraines and other non life-threatening conditions, the FDA advised women to carefully consider an alternative medication.
According to the FDA’s statement, the risk of birth defects is “particularly high during the first trimester, before many women know they are pregnant.”
Data on Depakote Birth Defects
In the United States, neural tube defects affect approximately 1 in 1500 babies. With use of Depakote during pregnancy, that rate increases to 1 in 20.
The rate of major malformations in babies exposed to Depakote was also found to be four times (4x) higher than the rate of malformations with other antiepileptic medications. Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry showed that 10.7% of infants exposed to Depakote at higher doses in utero developed major birth defects, compared to only 2.9% in those exposed to alternative epilepsy drugs.
Depakote and Your Child’s IQ
More recently, the FDA warned patients that Depakote can cause decreased IQ scores in children exposed to the drug during pregnancy.
For the treatment of migraines, the FDA announced in May 2013 that the risk to pregnant women clearly outweighs any possible benefit of the drug.
For the treatment of epilepsy or bipolar disorder, the FDA advised that pregnant women should only use Depakote if other medications are not effective or otherwise unacceptable in the patient’s case.
For women of childbearing age who are not pregnant, the FDA warned that Depakote should not be taken for any condition unless essential to managing the patient’s medical condition. The FDA further advised all non-pregnant women of childbearing age who take Depakote to use effective birth control.
A medical study entitled Neurodevelopmental Effects of Antiepileptic Drugs (NAED) compared the results of IQ tests in children exposed to four different antiepileptic drugs. Children were assessed at age three and again at age six. The study found that children exposed to Depakote in utero scored between 8 and 11 points lower than with lamotrigine (marketed as Lamictal), carbamazepine (Carbatrol, Equetro, Tegretol), or phenytoin (Dilantin).
Suicidal Thoughts from Depakote
In addition to birth defects and impaired cognitive development in babies, Depakote can cause increased suicidal thoughts and behavior in primary users of the drug. Since 2008, the FDA has required the manufacturer of Depakote to include warnings about the risk of depression, suicidal thoughts, and unusual changes in mood or behavior. This risk applies to antiepileptic drugs as a class, and not to Depakote alone.
Depakote Litigation
A number of Depakote lawsuits are underway to compensate victims of birth defects and their families. More information about the Depakote litigation is available on this website. For an evaluation of a potential case, you can reach our experienced Depakote attorneys at (866) 808-2424 or through our online form at any time.