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Is Depakote to Blame for Birth Defects?

Is Depakote to Blame for 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)
• Craniosyntosis
• 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.

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.

http://www.fda.gov/Drugs/DrugSafety/ucm261543.htm

http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm

Depakote Lawsuit Help: Contact Us

We’re here to help anyone who has legal questions about Depakote side effects. If you or someone you know took Depakote while pregnant, you’re probably wondering about whether or not you can pursue a lawsuit. At Parker Waichman LLP, we offer free, no-obligation case evaluations. Feel free to contact us by filling out our online form or calling our office at 1(800)-LAW-INFO (1-800-529-4636).