Since 2006, the drug Depakote — used to treat migraines, bipolar disorder and epilepsy — has faced mounting concerns over its side effects, particularly the birth defects in babies born to women who took the medication while pregnant.

That year, the FDA added a black-box warning about the potential for congenital birth defects. It came on the heels of a study that found birth defects in 20 percent of women who gave birth while taking Depakote.

In 2009, the FDA issued another warning, this time about potential neural tube defects, heart defects and craniofacial birth defects. This warning also included a precaution about suicidal thoughts and actions associated with Depakote use.

A 2011, an FDA warning addressed a potential link between Depakote and decreased cognitive functioning in children born to mothers who took the medication during pregnancy.

The FDA’s conclusion was based on a study that showed children born to these mothers tended to score lower on cognitive tests, such as IQ tests, than children born to mothers who took other anti-seizure medications during pregnancy.

Cognitive tests assess development in a variety of areas, including intelligence, abstract reasoning, and problem solving.

A 2010 study published in the New England Journal of Medicine reported that European researchers saw an increased risk of six different birth defects when the mother took Depakote during the first trimester of pregnancy. There was a 12-fold increase in cases of spina bifida, for example, for mothers who were prescribed the drug.

In 2013, another study of 500 women between 2000 and 2004 reported that the risk for neurodevelopmental problems was greater in women who used Depakote during pregnancy.

In 12 percent of the cases, women in the study gave birth to children who later had developmental problems.

Medical researchers believe that higher dosages of Depakote equates to greater risks for developing long-term developmental problems for their children.

Depakote has been used in the United States since 1983. It is in a class of drugs known as anticonvulsants that work in the brain to stop seizures and its uses include treatment for epilepsy, migraines, and manic bipolar episodes.

Its manufacturer, Abbott Laboratories, has been named as a defendant in a growing number of Depakote birth defect lawsuits that claim that Abbott is responsible for babies’ birth defects because the company failed to adequately warn women and their healthcare providers about the drug’s risks.

In 2012, a federal Depakote lawsuit forced Abbott Laboratories to pay more than a billion dollars in penalties for engaging in illegal marketing to promote the drug as a way to calm to elderly dementia patients in nursing homes. Of the $1.6 billion settlement, $500 million was a criminal fine. Abbott reportedly paid illegal kickbacks to doctors for prescribing the medication.

Abbott Labs also settled with the state of Arkansas for marketing Depakote for unapproved, off-label uses such as for the treatment of autism and schizophrenia.