Depakote May Cause Birth Defects. Depakote is a drug used to help treat seizures, migraines and occasionally bipolar disorder. Patients are prescribed this anticonvulsive medication with the expectation that it’ll help treat their condition, but in fact Depakote may do just the opposite. As for pregnant women, strong evidence suggests that this drug may cause birth defects in children whose mothers took Depakote. This alleged side effect has led some Depakote users to file a lawsuit against the manufacturer. According to these cases, Abbott not only developed a harmful drug, but they also allegedly knew about the risks and chose to hide them from the public.
Research Shows that Taking Depakote May Lead to Birth Defects
Depakote is manufactured by Abbott Laboratories; its generic name is divalproex sodium or valproic acid. The U.S. Food and Drug Administration (FDA) approved Depakote in 2000. Since its time on the market, this epilepsy drug has caused experts and users alike to worry about its potentially detrimental side effects, especially birth defects. In May 2007, doctors began reporting that pregnant mothers who took Depakote to treat their epilepsy had a higher risk of giving birth to a baby with mental deficits. At the annual meeting of the American Academy of Neurology in Boston, researchers said that toddlers who were exposed to Depakote in the womb generally scored seven to eight points lower on an IQ test compared to those whose mothers took a different epilepsy drug.
Another study about Depakote birth defects was published in the New England Journal of Medicine (NEJM) in June 2010. In this study, researchers found that the drug increased the risk of the following six birth defects:
- Cleft palate
- Polydactyly (extra fingers or toes)
- Spina Bifida
- Atrial Septal Defect (hole in the heart)
- Hypospadias (abnormal opening in a boy’s urethra)
The NEJM study found that spina bifida was 12 times higher in children whose mothers took Depakote. The risk of hypospadias was five times higher and craniosyntosis was seven times as common.
Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry has also supported the idea that drugs like Depakote are associated with birth defects. An analysis using this database found that the chance of giving birth to a child with a neural tube defect was 1 in 20 for women taking valproate, the main active ingredient in Depakote, during the first trimester. This compares to a 1 in 1,500 chance for mothers not taking this drug.
2013 Studies Reinforce Links to Birth Defects in 2013
Two new studies, one published on Jan. 31 in the journal of Neurology, Neurosurgery & Psychiatry, the other published on March 6 in the international journal Acta Neurologica Scandinavica, further bolster evidence from previous studies regarding links between valproate and birth defects.
The aim of the first study, as noted on Neurology, Neurosurgery & Psychiatry, was to compare the prevalence of diagnosed neurodevelopmental disorders in children exposed, in utero, to different antiepileptic drugs. A cohort of women with epilepsy and a control group of women without epilepsy were recruited from antenatal clinics. The study followed the children until the age of 6. Results showed an increase in the risk of neurodevelopmental disorders in children exposed to valproate, with autistic spectrum disorder the most frequent diagnosis.
The March study in Acta had for its objective the study of associations between patterns of fetal malformation and individual antiepileptic drugs taken during pregnancy. Researchers analyzed data relating to 1,733 fetuses from 1,703 pregnancies (147 of which were not exposed to antiepileptic drugs during pregnancy). The study found “statistically significant associations between valproate exposure and spina bifida, malformations of the heart and larger vessels, as well as digits, skull bones, and the brain.” It added: “The valproate findings are mostly in keeping with the published literature.”
FDA Warns Against Pregnant Women Using Depakote
The FDA has made several modifications to the Depakote safety level since the drug was introduced to the United States in 2000. In 2009, the label was updated to warn that valproate and other related drugs were linked to a higher risk of neural tube defects, craniofacial defects, cardiovascular malformations and other serious side effects when taken by pregnant women. In June 2011, the agency warned that taking Depakote while pregnant may be associated with cognitive impairments. The FDA stated that the label would be update to include this information. The FDA updated the Depakote safety label again in May 2013, issuing a similar warning that it should not be taken by pregnant women for migraine treatment as this could lead to lower IQ scores among children.
FDA Ramps Up its Focus on Decrease IQ Scores Following ‘in Utero’ Exposure to Depakote
The FDA issued another label update in June 2013. Since May, the FDA has been sounding the alarm for health care providers and patients, warning them that medications including and related to valproate sodium, such as Depakote, can cause decreased IQ scores in children whose mothers took the medication during pregnancy. These drugs are now contraindicated for—and should never be used by—pregnant women for the prevention of migraine headaches. Specifying this includes Depakene (valproic acid) Capsules and Oral Solution, Depakote (divalproex sodium) Delayed Release and Depakote ER (Extended Release) Tablets, Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), Depacon (valproate sodium) Injection, the FDA noted that published studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed in utero to another antiepileptic drug or to no antiepileptic drugs. One study, conducted in the U.S. and U.K., found that children with prenatal exposure to valproate had lower IQ scores at age 6 than children with prenatal exposure to other antiepileptic drug treatments. It is not known precisely when during a pregnancy cognitive effects in valproate-exposed children occur. Women in the study were exposed to antiepileptic drugs throughout their pregnancy, so whether the risk for decreased IQ was related to a particular time period during pregnancy cannot be assessed.
In addition to lowering IQs, valproate can cause neural tube defects and other structural abnormalities (such as craniofacial defects, cardiovascular malformations and malformations involving various body systems). The rate of congenital malformations among babies born to mothers using valproate is about four times higher than the rate of babies born to epileptic mothers using other anti-seizure medications. Based on available evidence, taking folic acid supplements prior to conception and during the first trimester may help to offset the risk for congenital neural tube defects.
- FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
- FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children