Depakote is one of the most commonly prescribed anticonvulsants in the United States, having gained millions of prescribers over the years. However, this popular seizure medication has been at the center of product liability lawsuits for allegedly causing birth defects to develop in unborn fetuses.

This drug, which is manufactured by Abbott Laboratories, has been on the market since 1983 and has since garnered a large following in the medical community. Numerous patients have reported success in using Depakote to treat their epilepsy, migraines, and manic and bipolar episodes. However, there have been numerous allegations of birth defects against Abbott by mothers who had taken Depakote while pregnant and allegedly gave birth to children suffering from birth defects.

Overview of Depakote Birth Defect Complications

The FDA first acknowledged the risk of Depakote birth defects in 2006, after numerous injury reports were submitted to the FDA, and after reviewing scientific studies. Medical research indicated that pregnant women who are prescribed Depakote had a 20 percent greater risk of their babies being born with birth defects. After reviewing these findings, the FDA added a black-box warning to Depakote’s warning label with greater detail released in 2009. The FDA reportedly came to this decision after analyzing data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The data from the registry indicated that more than 10 percent of pregnant women who are prescribed Depakote had given birth to an infant with some kind of birth defect.

The FDA also cited the more severe birth defects infants could be born with after Depakote exposure. These birth defects include: cardiac, craniofacial, and neural tube defects in developing fetuses. In general, numerous scientific studies have indicated that anticonvulsants and other medications have negative side effect on developing fetuses, but prescription drugs have some of the worst injury reports. Medical experts explain that the biggest risk involved in prescription medications for pregnant women stems from what stage of pregnancy they take the drugs. The first trimester is the most crucial development stage for the fetus and it is also when it is the most vulnerable to the possible Depakote birth defects.

Further research on this subject was published in 2010 of the New England Journal of Medicine, which highlight six birth defects that seemed the most likely to occur with Depakote use. Each of the subjects had taken Depakote during their first trimester of pregnancy. The spinal defect and spina bifida seemed to be the most most common with a 12 times greater risk compared to women who were not prescribed Depakote. Other common Depakote birth defects include: cleft palate, holes in the heart walls, skull malformations, extra fingers and toes, urinary complications, and smaller limbs. Additionally, prior birth defects studies have found that babies born from women who were prescribed Depakote were born with lower IQ than compared to babies free of Depakote exposure.

With all this negative press, pregnant women who are in need of anticonvulsants to control their symptoms often find themselves choosing between the safety of their unborn child and their mental health. Even with some scientists arguing against prescription medications during pregnancy, other experts argue that it is just as important that the mother maintain her health as well as ensure the health of the baby.

Ultimately, physicians state that adequate warnings need to be included on medication labels to prevent any unnecessary injuries. In the case of Depakote, pregnant women should talk to their doctors about being prescribed an anticonvulsant medication with lower risk of fetus harm.