Amanda Antell  |  March 30, 2015

Category: Legal News

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generic Zoloft birth defectsDepakote has been on the market since 1983, treating millions of patients with epilepsy. Unfortunately, this popular medication has been blamed for potentially causing severe birth defects.

The U.S. Food and Drug Administration (FDA) has also taken issue with this allegation, warning that pregnant women should not take Depakote. Additionally, the FDA states that the manufacturing company, Abbott Laboratories, has not sufficiently mentioned the possibility of birth defects on the drug’s label.

Studies Suggest Depakote Birth Defects

According to experts, the concern of birth defects is highest during the first trimester of pregnancy, which is when physical and mental development begins. Several studies have observed different drug interactions in first trimester fetuses, including Depakote. In fact, a European study from 2010 found that women who take Depakote during the first three months of pregnancy put their baby at an increased risk for Depakote birth defects. This study was published on June 10, 2010 in the New England Journal of Medicine, conducted by researchers of the University of Groningen of the Netherlands.

The study analyzed over 98,000 pregnancies, and found that six different birth defects were more likely to occur with Depakote use. In particular, the study found that spina bifida was 12 times more likely to occur, with certain cardiac complications and physical deformity the risks increased by two to seven times:

  • Five Times Increased Risk for Hypospadias (opening of the urethra in boys is on the underside of the penis)
  • Seven Times Increased Risk for Craniosynostosis (the bones of the skull close too early)
  • Two Times Increased Risk for Polydactyly (condition where the child has more than five fingers per hand)
  • Five Times Increased Risk for Cleft Palate (facial deformity)
  • Two Times Increased Risk for Atrial Septal (a hole in the wall between the heart’s upper chambers)

The researchers gathered data from past studies and compared them against the antiepileptic study database from the European Surveillance of Congenital Anomalies (EUROCAT). As indicated before, the researchers found that certain birth defects occurred in babies whose mothers had taken Depakote during pregnancy.

Lead researcher Lolkie T.W. de Jong-van den Berg and his colleagues state that these while these findings were inconclusive, they did reflect the Depakote birth defects concerns brought up by the American Academy of Neurology.

Furthermore, the researchers stated that additional studies would be needed and that pregnant women should be highly cautious of Depakote, as well as any other drugs known to cause birth defects. This concern was proven relevant a year later, when the FDA issued a warning for future parents about Depakote causing slower brain function.

Studies have also indicated women who used Depakote had children who scored lower on IQ tests, compared to babies born from mothers who did not take Depakote. While slower cognitive function is not an obvious birth defect, it can still be considered a side effect that may have been caused by Depakote.

Overview of Depakote Birth Defect Allegations

As a popular anticonvulsant, Depakote is often prescribed to treat attention deficit hyperactivity disorder (ADHD) and chorea (hyperactive movement disorder). However, the concern of Depakote birth defects has been rampant since 2006, when the FDA added a black box warning to the drug’s label for potential birth defects.

This warning was updated several years later in 2009, when the FDA noticed specific birth defects frequently occurring like neural tube defects, heart defects, and craniofacial birth defects. While Depakote birth defects are widely known now, this was not the case before the FDA safety announcement, which exposed unborn babies to this risk for decades.

Many parents were angry with Abbott Laboratories for allegedly concealing this information, despite knowing the severity of the risks. Many of these parents have filed legal action against Abbott on behalf of themselves and their children, for failing to protect them against adverse Depakote side effects.

In general, Depakote lawsuits are filed individually by each plaintiff and are not class actions.

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