The number of Depakote lawsuits continues to grow with allegations that manufacturers failed to warn pregnant women that the epileptic medication could cause birth defects.

Recent studies have found that fetal exposure to Depakote increases the risk of having a child born with a life threatening birth defect by 12 percent, especially when taken during the first trimester. A large number of birth defect lawsuits have been filed against Depakote makers Abbott Laboratories and Abbvie Inc., claiming they knew of the risks but did little to warn women in their childbearing years.

Some of the most commonly reported Depakote birth defects due to fetal exposure include:

• Brain defects
• Heart defects
• Cleft palate
• Polydactyly (hand and foot malformations)
• Skull defects
• Spina bifida and other spinal defects
• Atrial septal defect (hole in the heart)
• Hypospadias (a condition in male babies that causes the opening of the urethra to occur in the wrong place)

Depakote Overview

Depakote is an anti-seizure medication prescribed to millions each year. It was approved by the FDA in 1983 as a seizure treatment, but by 2002 Depakote was being prescribed for other conditions like bipolar disorder, manic depression, migraines, and pancreatitis. The medication reportedly works by increasing the amount of neurotransmitter gamma aminobutyric acid (GABA) in the brain, which helps prevent certain brain signals that could lead to seizures.

However, due to the significant evidence that Depakote was linked to severe birth defects, the FDA started warning pregnant women in 2009 that the drug was considered a pregnancy Category D. This means that there is evidence of fetal risk, but some benefits may warrant use of the drug. By 2013, the FDA announced that Depakote should be considered a pregnancy Category X when used as a migraine prescription, and that the risks outweigh any potential benefits of the medication.

Depakote Studies

Depakote has been the subject of numerous medical studies over the years, both in the U.S. and around the world. In one European study, researchers looked at four million births along with 98,000 birth defects. The researchers concluded that women who took Depakote while pregnant were 12 times more likely to have a child born with a defect than those who did not take the medication.   

In addition to that study, the New England Journal of Medicine also published a study in 2010 that found that Depakote increased the risk of birth defects.

Yet another study, performed by the National Institutes of Heath (NIH), focused their research on discovering if there were any adverse side effects of Depakote on breastfeeding infants. While their findings did conclude that Depakote entering the milk supply may cause infants to become drowsy and sedated, they also found that the Depakote side effects ended once breastfeeding mothers stop taking the medication.

Increase in Depakote Lawsuits

As more studies confirm that Depakote is linked to certain serious birth defect patients, more individuals continue to file lawsuits claiming they were never warned. Most plaintiffs seek financial compensation to help cover the high medical costs of on-going treatment that most of these conditions require. Some Depakote lawsuits claim manufacturers knew of the increased risk of birth defects, yet intentionally concealed the information from patients and the medical community. 

If you were prescribed Depakote during pregnancy and later had a child born with a birth defect, you may have legal claim.