More Research Needed on Depakote

Chicago, ILWith studies suggesting a risk of Depakote side effects when women who are pregnant take the medication, the US Food and Drug Administration (FDA) has issued its own warnings about the use of Depakote while pregnant. Because Depakote (known generically as valproic acid) is used as an anti-convulsant and a mood stabilizer, women of child-bearing age may have no choice but to use the medication if they do not tolerate other anti-convulsant medications, and run the risk of Depakote birth defects.

Specifically of concern are a reported risk of decreased IQ and a risk of autism that have been linked to the use of valproic acid. “The emerging clinical evidence showing a link between VPA [valproic acid] exposure and both cognitive function and risk of autism brings to the forefront the importance of understanding how VPA exposure influences neurodevelopment,” researchers wrote in a study published in Neurotoxicology and Teratology (found online at www.ncbi.nlm.nih.gov; 2/8/13).

They went on to note that behavioral studies on rats and mice show that exposure to valproic acid increases autistic-like behaviors in offspring. Those behaviors include repetitive behaviors, communication problems and social behavior issues. Studies on humans indicate similar findings, but more research is needed.

A study published online in The Lancet Neurology (1/23/13), for example, found that children six years of age who were exposed to Depakote prior to birth had an average IQ of 97, compared with children not exposed to Depakote who had an average IQ of 105. This finding was reportedly dose dependent, meaning the higher the dose that the children were exposed to, the greater the impact on IQ. Among the cognitive tests included in the study were memory and verbal abilities.

The findings led researchers to conclude that valproate usage by a pregnant mother has a “significant negative effect” on the child’s IQ. Furthermore, this effect lasts well into childhood.

In June 2011, the FDA issued a warning about fetal exposure to Depakote and a risk of cognitive problems. The warning noted that children exposed to valproate or related products prior to birth tend to have lower IQ and cognitive test scores than children exposed to other anti-seizure medications. Among the cognitive tests included in the FDA’s warning were abstract reasoning and problem solving.

Depakote is approved to treat seizures, bipolar disorder and migraine headaches.