Depakote, known generically as valproic acid, is an anti-seizure medication that is a treatment for epilepsy. Depakote is also used to treat mania in people with bipolar disorder, and to prevent migraine headaches.

Use of the medication comes with some risk. Strong evidence suggests Depakote may cause birth defects.

Depakote birth defects have led some mothers to file Depakote lawsuits against Abbott Laboratories, the manufacturer of the drug. According to these Depakote birth defects lawsuits, Abbott allegedly knew about the risk of birth defects associated with Depakote and concealed this information from the public.

Two Studies Link Depakote to Birth Defects

In its 14 years on the market, Depakote has raised concern among experts and users alike about the epilepsy drug’s potentially dangerous side effects, especially birth defects. A 2010 study published in the New England Journal of Medicine (NEJM) found that Depakote increased the risk of the following birth defects:

• Cleft palate
• Polydactyly (hand and foot malformations)
• Craniosyntosis
• Spina bifida
• 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)

The 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.

In March 2013, a study published in the international journal Acta Neurologica Scandinavica, supported evidence from the previous study. Researchers in the Acta study 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 [Depakote] exposure and spina bifida, malformations of the heart and larger vessels, as well as digits, skull bones, and the brain.” It added: “The [Depakote] findings are mostly in keeping with the published literature.”

FDA Warns Against Using Depakote In Pregnancy

In 2009, the U.S. Food and Drug Administration (FDA) warned that pregnant women taking Depakote and similar drugs were at an increased risk of having a baby with certain birth defects. According to the agency, neural tube defects, such as spina bifida, are the birth defects most often seen with Depakote use in pregnancy.

Research reviewed by the FDA indicated the risk of a child getting spina bifida from a mother who took Depakote or a similar drug while pregnant is 1-2 percent, or one or two out of every 100 children.

In addition to these dangers, the FDA released a safety alert on May 6, 2013 stating that Depakote and other drugs like it should not be given to pregnant women to prevent migraine headaches, as a new study has revealed that it can result in lower IQ scores in children born to women who took the drug while pregnant.

In addition to issuing this alert, the FDA announced that it would be changing the warning on these drugs from “D” to “X,” indicating that the risks associated with this medication outweigh the potential benefits it could have for pregnant women looking to prevent migraines.

Depakote Birth Defects Lawsuits

A large number of birth defects are caused by pharmaceutical drugs. While many drugs are safe during pregnancy, others pose serious dangers. Often the warning about a dangerous or defective drug comes months or years after the initial link to birth defects are discovered.

Mothers who take certain drugs during pregnancy may unknowingly be at an increased risk of giving birth to a child with serious birth defects. A number of Depakote lawsuits have been filed due to the drug’s link to birth defects.