Depakote has been a popular epilepsy treatment since hitting the market in 1983. Millions have taken the prescription drug to manage seizures. But the U.S. Food and Drug Administration (FDA) recently took action to caution doctors about prescribing the drug to pregnant women.

In fact, concerns over inadequate warnings about potential birth defects have landed Depakote’s maker, Abbott Laboratories, in legal trouble.

What is Depakote?

Depakote
is also known as valproic acid or divalproex sodium. It belongs to a class of drugs called anticonvulsants. These drugs help manage brain activity and are often prescribed to treat conditions such as epilepsy, migraines and bipolar disorder.

Depakote is sometimes prescribed for other conditions such as attention deficit hyperactivity disorder (ADHD) and chorea (hyperactive movement disorder). But the drug has been linked to serious side effects.

Study Links Depakote To Birth Defects Risks

In 2010, European researchers published the results of a Depakote birth defects study, which found that Depakote increases the risk of birth defects when taken as early as the first trimester of pregnancy, before many women even know they are pregnant.

The study published in the New England Journal of Medicine, reported an increased risk of six different birth defects when Depakote is taken during the first trimester.

The risk for spina bifida, in particular, increased 12 times for mothers who were prescribed the drug. Additionally, there was a seven-fold increased risk of craniosynostosis (abnormal skull), a five-fold increased risk of cleft palate, and 2.5 times the risk of the baby developing heart defects such as a septal defect or a hole in the heart.

Depakote and Birth Defects

The most dangerous side effects of Depakote involves damage to an unborn fetus. These Depakote birth defects include:

• Cleft palate
• Hypoplastic right heart (a condition that results in an underdeveloped right side of the heart)
• Undescended testes
• Hand malformations
• Dysplastic (abnormally developed) ribs
• Hypospadia (a condition in male babies that causes the opening of the urethra to occur in the wrong place)
• Spina bifida (a condition that results in the spinal column failing to completely enclose the spinal cord)
• Fetal death

Depakote Lawsuits

After decades on the market, women and their health care providers were allegedly not adequately warned about the drug’s risks. Drug makers have an ongoing duty to test the safety of their drugs and warn the public and health care providers about the risks.

An adequate warning was particularly important for patients because Depakote birth defect risks increase as early as the first trimester, when women may not realize they are pregnant. That is why many families are filing Depakote lawsuits against Abbott Laboratories for their babies’ alleged Depakote birth defects.