A new study of psychotropic drug use by expecting mothers shows a link between psychotropic drugs like Depakote and certain birth defects.

The study, published in the Journal of Clinical Psychiatry, reviewed data from over 1,000 mothers and their children from 13 French mother-baby units. Researchers found an increased incidence of low birth weight associated with use of mood stabilizers such as Depakote during pregnancy. They concluded that exposure to psychotropic drugs during pregnancy results in less optimal outcomes for infants and that such infants should be considered a high-risk population.

Depakote Birth Defects

Depakote is the brand name of divalproex sodium, one of a few different forms of valproate sodium. Valproate also appears as valproic acid in Depakene and Stavzor and on its own in Depacon.

Depakote was originally approved by the U.S. Food and Drug Administration (FDA) in 1983 for the treatment of epilepsy. Currently, Depakote is also approved for treatment of manic episodes of bipolar disorder and prevention of migraine headaches. Some physicians also prescribe Depakote for other unapproved, or “off-label,” uses.

Depakote has been linked to a number of debilitating birth defects. In May 2013, the FDA issued a Drug Safety Communication warning pregnant mothers of a link between taking Depakote for migraines and decreased IQ scores in their children. The warning was based on a study of 6-year-old children who had been exposed to different antiepileptic drugs during their mothers’ pregnancy. Those children who had been exposed to valproate products typically had an 8- to 11-point reduction in IQ by age 6 as compared to those exposed to other antiepileptic drugs.

The FDA communication announces a change of Depakote’s pregnancy category for migraine use from “D,” meaning the potential benefit may outweigh the risks, to “X,” meaning the risks are so great that they clearly outweigh any possible benefit. This communication followed up on a 2011 FDA warning that exposure to valproate products like Depakote during pregnancy was associated with an increased risk of lower cognitive test scores later in childhood.

Prior FDA warnings also addressed an increased risk of serious physical malformations associated with neural tube defects where the mother took valproate products during the first 12 weeks of pregnancy. Studies then showed a four-fold greater risk of neural tube defects resulting in major malformations such as craniofacial defects and cardiovascular malformations. Other physical Depakote birth defects can include spina bifida, cleft palate or cleft lip, malformed limbs, and urinary tract problems.

Depakote Lawsuits

Abbott Laboratories, the maker of Depakote, has faced no small amount of litigation over Depakote birth defects. In 2012, the U.S. Department of Justice brought civil and criminal charges against Abbott for unlawfully marketing Depakote for off-label uses such as treatment of symptoms of dementia and schizophrenia. That prosecution left Abbott on the hook for $1.6 billion in fines. Recently an appeals court reopened that same case, based on a petition from three union health benefit funds claiming the prior settlement did not cover harm to private parties that resulted from the off-label marketing.

Many private individuals have initiated their own Depakote lawsuits. Depakote lawyers are actively investigating cases in which birth defects occurred following Depakote use prior to 2010.