Depakote can be a godsend for people with epilepsy, bipolar, and migraines. But for pregnant mothers, the drug could carry the risk of serious Depakote birth defects.

Depakote was first approved to treat epilepsy in the early 1980s. In its first year on the market, more than 2 million prescriptions were filled for the anticonvulsant.

However, like many drugs that act on the brain, it was later discovered that the drug could treat other conditions and it was subsequently approved for use treating bipolar disorder in the 2000s. In this same time frame, Depakote was also approved to treat migraine headaches and pancreatitis.

However, evidence has come to light that Depakote birth defects may be a very serious concern. In 2007, the U.S. Food and Drug Administration issued a warning that Depakote may carry the risk of Depakote birth defects.

The FDA based this drug safety announcement, and accompanying changes to the drug’s labeling, on post-market reports of birth defects involving mothers who took Depakote during pregnancy. Additionally, animal studies supported the idea of Depakote birth defects.

As such, the FDA rated Depakote as “Class D,” which means that there were not enough controlled, systemic human studies to conclusively prove that Depakote could cause human birth defects, but animal studies and post-market reports suggested that Depakote could cause birth defects.

Subsequent studies have suggested that Depakote could increase the risk of birth defects. This, coupled with the fact that the legal system has a different standard of evidence than the FDA, means that Depakote birth defect lawsuits could potentially play out in favor of the plaintiffs, if the plaintiffs could convince the court that the birth defects in question were caused by Depakote.

More recent Depakote birth defect studies have suggested a number of very specific birth defects were linked with Depakote use. One study found that mothers that took Depakote during the first trimester had two to seven times the normal rate of birth defects.

These alleged birth defects included heart defects, skull/brain defects, and spinal defects. This included a CDC study that found that Depakote mothers were 12.5 times more likely to have a child with spina bifida, a condition where the spine doesn’t fully close, leaving a bulge of spinal tissue at the base of the back, causing paralysis and other problems.

Another related birth defect is Craniosynotosis, a skull birth defect in which the sutures of the skull join together prematurely, causing the head to be malformed.