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The findings of a new study suggest that side effects of Depakote, Depakene, and similar epilepsy drugs used during pregnancy may increase the risk of children later developing Attention-Deficit/Hyperactivity Disorder (ADHD).
In findings published in the medical journal JAMA Network Open, researchers from Denmark report that pregnant women who took Depakote (valproate) increased their chance of giving birth to a child with ADHD by about 50 percent.
Researchers evaluauted data on 913,302 children born in Denmark from January 1, 1997, to December 31, 2011, and looked for information on their mothers’ exposure to antiepileptic drugs (AED), including drugs containing valproate, such as Depakote and Depakene. They also looked to see which children were diagnosed with ADHD by December 31, 2015.
According to the findings, 580 children were born to mothers who took Depakote or Depakene during pregnancy. Of those, 49, or 8.4 percent, were diagnosed with ADHD. That compares to only 3.2 percent of children who were not exposed to valproate in the womb.
The researchers calculate that taking the drugs during pregnancy was linked to a 48% increased risk of giving birth to a child with ADHD. No other antiepileptic drug appeared to increase the risk of ADHD.
“Maternal use of valproate, but not other AEDs, during pregnancy was associated with an increased risk of ADHD in the offspring,” the researchers concluded. “These findings have important implications for the counseling of women of childbearing potential using valproate.”
Depakote (valproate) is prescribed for treatment of seizures and bipolar disorder, as well as migraine headaches, but has been linked to a number of serious health concerns for unborn children when used by pregnant women.
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. Plaintiffs say the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication 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.