Fathers’ Depakote Use Linked to Developmental Disorders in Children: Study

Researchers recommend that doctors look for alternatives to prescribing Depakote for men of child-bearing age.

A new study suggests men who take Depakote face an increased risk of having children with neurodevelopment disorders, raising serious questions about the warnings provided about use of the anticonvulsant and mood stabilizer among men during early adulthood.

In a study published in JAMA Network Open on November 10, researchers indicate the offspring of men who used Depakote had a 50% higher risk of conditions like attention-deficit hyperactivity disorder (ADHD), autism, learning and intellectual disabilities, and other disorders.

Depakote (valproate) was first approved by the U.S. Food and Drug Administration in 1983, and is a common treatment for epilepsy, depression and bipolar disorder, as well as for migraine headaches.

Depakote Pregnancy Risks

While prior research and federal regulators have warned about the risks Depakote poses during pregnancy, those studies focused almost entirely on the mother’s use.

By 2006, the FDA added a “black box” warning about 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 additional restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines.

In 2020, researchers from Indiana University warned Depakote taken during pregnancy doubled the risk of the child developing ADHD and autism. That was followed by a study published in 2022 that indicated epilepsy drugs like Depakote and Topamax taken during pregnancy increase a child’s likelihood of developing autism and intellectual disability. A Harvard study two years later appeared to confirm those results, also finding that pregnancy use of the drug was linked to a higher risk of developing autism.

That same year, data published by a team of international researchers warned pregnant women with epilepsy need better medical care, indicating that many side effects posed by epilepsy and medication risks can be avoided with improved prenatal and maternal support.

For the new study, a team of international researchers analyzed data for 5,700 children from Denmark, Norway and Sweden. They used population-based data from the Nordic registry focusing on children born between 1997 and 2018 in Denmark, 2010 and 2019 in Norway, and 2007 and 2019 in Sweden.

The researchers, led by Dr. Sandrine Colas, looked for children of fathers who had taken either Depakote, Lamictal or Keppra three months before their children were conceived. All three drugs are different types of anticonvulsant medications for epileptics.

The data indicated paternal exposure to Depakote significantly increased the child’s risk of being diagnosed with neurodevelopment disorders. The risk was not seen among children whose fathers took Lamictal or Keppra.

In Denmark, nearly 6% of children whose fathers took Depakote developed a neurodevelopment disorder, compared to 3% of children born to dads who took Lamictal. In Norway, 4% of children born to fathers who used Depakote developed neurodevelopment disorders like ADHD or autism, compared to 2% of those who used Lamictal or Keppra.

Similar results were also seen in Sweden, where 6% of children born to fathers who took Depakote developed neurodevelopment disorders, versus only 3% of those who took Lamictal.

Once adjusted for other factors, the researchers concluded that the risk of a child having a neurodevelopment disorder was 50% higher if their father took Depakote before conception when compared to the other epilepsy drugs.

They concluded that the findings highlight the need for doctors to consider the risks Depakote may pose to children when fathers take the medication up to three months before their child is conceived. Researchers recommended alternative medications should be discussed with male patients of reproductive age.

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