Depakote Use During Pregnancy Linked to Psychiatric Problems in Childhood, Study Warns

The findings of a new study raise additional concerns about the side effects of Depakote during pregnancy, indicating that the widely used antiepileptic drug may cause unborn children to develop a wide range of neurological problems, such as ADHD and anxiety.

Scandinavian researchers warn that prenatal Depakote exposure increased the risk of psychiatric problems in children by 42%. The same study also found that some similar epilepsy drugs, like Topomax and Keppra XR, increased the risk of specific disorders, such as attention-deficit hyperactivity disorder (ADHD) and anxiety significantly as well.

Depakote (valproic acid, or valproate) is commonly prescribed for treatment of seizures and bipolar disorder, as well as migraine headaches. However, it has previously been linked to a number of potential health concerns, primarily involving unborn children who suffer birth defects after being exposed to the medication before birth.

Depakote Psychiatric Problems for Unborn Children

In findings published this week in the medical journal JAMA Neurology, researchers outlined the results of a cohort study involving 38,661 children, looking at the effects of a wide range of antiseizure medications taken during pregnancy. The children were born between January 1, 1996, to December 31, 2017.

Researchers from Denmark, Norway, Finland and other European countries looked for data on 13 different psychiatric disorders, indicating that children born to mothers who took Depakote faced a 42% cumulative risk of suffering a psychiatric disorder, primarily on the neurodevelopmental spectrum, by the time they were 18.

According to the study, those given Topamax faced more than twice the risk of ADHD than their peers, and those given levetiracetam, sold under the brand names Keppra XR, Spritam and Roweepra, faced a 78% increased risk of ADHD, and more than double the risk of anxiety.

Researchers found no increased psychiatric risks linked to other epilepsy drugs, including Tegretol, Lamictal, Trileptal and Oxtellar XR.

“Findings from this explorative study strengthen the evidence for the warning against the use of valproate in pregnancy and raise concern of risks of specific psychiatric disorders associated with topiramate and levetiracetam,” the researchers concluded. “This study provides reassuring evidence that lamotrigine, carbamazepine, and oxcarbazepine are not associated with long-term behavioral or developmental disorders but cannot rule out risks with higher doses.”

Depakote Pregnancy Risks

Most concerns regarding the use of Depakote have centered around concerns over birth defects and other pregnancy complications.

In April 2018, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) barred doctors in that country from prescribing Depakote to women of childbearing age unless they are on a pregnancy prevention program.

According to the MHRA, up to 40% of babies born to mothers who take Depakote are at risk of developmental disorders, and 10% are at risk of birth defects.

Another epilepsy drug study published in February 2018 in JAMA Neurology, by researchers from Denmark again, found that children who were exposed to Depakote in the womb scored lower on language and math tests in the sixth grade, when compared to their peers.

In 2006, the FDA added a “black box” warning about the potential Depakote pregnancy side effects, after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.

Abbott Laboratories and AbbVie, a subsidiary it spun off, have faced hundreds of Depakote lawsuits in state and federal courts nationwide, involving allegations that the drug maker failed to warn women and the medical community about the risks associated with using Depakote during pregnancy.

Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales for AbbVie’s predecessor.