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Depakote and Autism and ADHD

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Depakote, a brand name of the anticonvulsant medication valproate, is commonly used to treat various medical conditions, including seizures, migraine headaches, and bipolar disorder. However, there is growing concern about the use of Depakote during pregnancy and the risk of autism and attention deficit hyperactivity disorder (ADHD) in children.

Recent studies suggest associations between the anti-epileptic drug Depakote and adverse health effects. One study found that it increased the death risk in post-stroke epilepsy patients. Another found an association between Depakote use during pregnancy and the Autism and ADHD risk in children. In addition, individuals have filed lawsuits in France against Sanofi, the European manufacturer of Depakote.

About Depakote 

Valproate, known by the brand name Depakote, is an anti-epileptic medication. It treats symptoms associated with epilepsy, seizures, bipolar disorder, and migraines. Depakote comes in 125, 250, and 500 mg delayed-release tablets, 250 and 500 mg extended-release tablets, and 125 mg sprinkle capsules. The Chicago-based biopharmaceutical giant AbbVie manufactures this drug in the United States, while Sanofi manufactures it in Europe.

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Common Depakote side effects include:  

  • Nausea
  • Vomiting
  • Double vision
  • Weight gain
  • Dizziness
  • Walking or coordination problems
  • Headaches
  • Stomach Pain
  • Weakness
  • Drowsiness
  • Increased appetite
  • Reduced appetite

Depakote’s Linked to Autism and ADHD

There is substantial evidence linking the use of Depakote (valproate) during pregnancy to an increased risk of autism in children. Several studies have indicated that prenatal exposure to Depakote is associated with a higher likelihood of developing autism spectrum disorder (ASD).

One significant study monitored over 665,000 Danish children and found that mothers who took Depakote during pregnancy were five times more likely to have children diagnosed with autism compared to those who did not take the drug. Specifically, 4.42% of children exposed to valproate in utero were diagnosed with autism, compared to only 1.02% of children whose mothers did not use the drug during pregnancy.

Research published in the New England Journal of Medicine also highlighted that antiseizure medications, including Depakote, significantly increased the risk of autism. The study indicated that 10.5% of children exposed to Depakote in the womb developed autism, a much higher rate than in the general population​.

These findings underscore the potential risks associated with using Depakote during pregnancy, leading regulatory agencies to issue warnings and restrictions. The UK’s Medicines and Healthcare Products Regulatory Agency, for instance, barred doctors from prescribing Depakote to women of childbearing age unless they are on a pregnancy prevention program due to the high risk of developmental disorders and birth defects​.

A study published in the New England Journal of Medicine found that children born to mothers who took Depakote during pregnancy were more likely to be diagnosed with autism or ADHD compared to children born to mothers who did not take the medication.

A December 15, 2020 study in Neurology found that Depakote use during the first trimester increased the autism and ADHD risk. Indiana University-based researchers examined Swedish-register data that comprised over 14,000 children born to epileptic mothers between 1996 and 2011. They found that over 22 percent of mothers used anti-seizure medications during their first trimester. The researchers’ data showed that Depakote increased the autism and ADHD risk. By contrast, they found no increased autism and ADHD risk for Lamictal and a statistically insignificant association for Tegretol. The researchers’ data suggested that some anti-seizure medications were safer for pregnant women than others.

In addition, other research has found that children exposed to Depakote in utero may have a higher risk of developmental delays and other neurodevelopmental problems. This has led to growing concerns about the safety of Depakote during pregnancy and the potential impact on the health of children.

To be clear, evidence regarding the link between Depakote and autism and ADHD is still developing and the results of studies are not conclusive. Some studies have found a link, while others have not. Further research is needed to fully understand the potential impact of Depakote during pregnancy.

New England Journal of Medicine Study

A recent study in the New England Journal of Medicine explored the relationship between the use of antiseizure medications during pregnancy and the risk of autism spectrum disorder in children. The research focused on three medications: Depakote, topiramate, and lamotrigine. The study analyzed data from pregnant women and their children in the United States, collected from 2000 to 2020. It assessed the risk of ASD in children based on their exposure to these medications during the second half of pregnancy.

The findings revealed that children exposed to valproate (Depakote) had a significantly higher incidence of ASD, with a rate of 10.5%, compared to 1.9% in children who were not exposed to any antiseizure medications. This risk remained elevated even after adjusting for various confounding factors. In contrast, the study found that the risk associated with topiramate was slightly higher but not statistically significant, and there was no significant increase in risk for children exposed to lamotrigine. Specifically, the adjusted hazard ratios were 0.96 for topiramate, 2.67 for valproate, and 1.00 for lamotrigine.

These results underscore the importance of carefully considering the use of valproate (Depakote) during pregnancy due to its substantial association with an increased risk of autism in children. This study highlights the need for alternative treatments for women of childbearing age who require antiseizure medication to minimize potential risks to their unborn children.

Other Concerns With Depakote

There is no question there are side effects with Depakote. They include:

  1. Nausea: This is a common side effect of Depakote and can cause discomfort, especially in the early stages of treatment.
  2. Dizziness: Depakote can cause dizziness and unsteadiness, especially when standing up from a lying or sitting position.
  3. Fatigue: Fatigue and drowsiness are common side effects of Depakote and can interfere with daily activities.
  4. Tremors: Some people taking Depakote may experience tremors or involuntary movements, especially in their hands or arms.
  5. Weight gain: Depakote can cause weight gain, which can be a concern for some people, especially those with weight-related health conditions.
  6. Liver problems: Depakote can cause liver problems, including liver damage and liver failure, which can be serious and potentially life-threatening.
  7. Pancreatitis: Pancreatitis, or inflammation of the pancreas, is a rare but serious side effect of Depakote that can cause abdominal pain and other symptoms.
  8. Blood disorders: Depakote can cause a decrease in the number of platelets and red and white blood cells, which can increase the risk of bleeding and infection.
  9. Birth defects: Depakote has been linked to an increased risk of birth defects, including neural tube defects and other congenital malformations, when taken during pregnancy.

Depakote increased the cardiovascular death risk by 40 percent in post-stroke epilepsy patients  

In a December 13, 2021, JAMA-published study, Norwegian and Swedish researchers found that cardiovascular death risk in post-stroke epilepsy patients who were treated with Depakote was 40 percent. They studied the effects of the anti-seizure medications, including Depakote, Dilantin, Keppra, Lamictal, Oxtellar XR, Phenytek, Tegretol, and Trileptal. Their data comprised Swedish adults who suffered a stroke between July 2005 and January 2010 and epilepsy before January 2015.

The researchers further narrowed their data to 2,577 anti-seizure medication patients. Their data showed that Lamictal, Keppra, and Tegretol decreased the patient death risk. By contrast, Depakote increased the death risk by 40 percent. Dilantin, Oxtellar XR, Phenytek, Trileptal increased the death risk by 16 percent. The researchers concluded that their findings suggested that death rates varied by medication.

Depakote use in pregnancy’s association with long-term academic performance 

A JAMA-published study from February 2018 showed that prenatal exposure to Depakote negatively impacted a child’s long-term academic performance. Researchers examined data that comprised over 650,000 Danish children born between the years 1997 and 2006. They identified over 1,400 children who were exposed to various anti-seizure medications, including Depakote, Luminal, Trileptal, Lamictal, Klonopin, and Tegretol. Their data showed that Depakote- and Klonopin-exposed children scored poorly on sixth-grade math and Danish tests compared to Lamictal-exposed and unexposed children. They also found that Luminal, Lamictal, Tegretol, and Trileptal were not associated with poor test scores. The researchers recommended that women of childbearing capabilities not take this Depakote.

FDA’s May 2013 safety announcement on Depakote  

The FDA’s May 6, 2013 safety announcement warned pregnant women against taking Depakote for migraines. It reported that taking the drug could result in lower IQ scores in children. The agency also announced that the drug’s manufacturers will include warnings of this risk on labels. It advised that Depakote patients of childbearing age should take birth control. The FDA advised healthcare professionals to not prescribe the drug to pregnant women for migraines and only prescribe it to pregnant women for epilepsy if alternative treatments were inadequate.

French authorities file charges against Depakote’s European manufacturer  

In February 2020, French prosecutors charged Sanofi Aventis with unintentional injury and aggravated fraud. They alleged that the pharmaceutical giant failed to inform the public on the association between Depakine, sold in the United States as Depakote, and birth defects. Depakine is sold in the United States as Depakote. French authorities began investigating the drug in September 2016. During that time, regulators also criticized Sanofi and ANSM, the government agency that regulates pharmaceuticals, for their slow responses to Depakine’s adverse side effects. Individuals also filed lawsuits against Sanofi, alleging that it misled the public on the drug’s safety. They also claim that the agency knew of its adverse effects and attempted to conceal them. Sanofi welcomed the case’s advancement. However, it claimed to have “always complied with its duty to inform and been transparent.”

French authorities indict Sanofi with manslaughter associated with birth defects  

In August 2020, French authorities indicted Sanofi with manslaughter for failing to report on Depakote’s birth defects. These charges were separate from the unintentional injury and aggravated fraud charges against the pharmaceutical giant. Sanofi denied any wrongdoing. It argued that it already warned authorities of Depakote’s adverse effects almost 40 years ago. Sanofi also contested the proceeding’s validity.

Depakote Lawsuits

Our law firm is not handling Depakote lawsuits, at least not at this time.