Depakote Warnings
The Food and Drug Administration warned in December 2009 that women who use the epilepsy and migraine drug Depakote during pregnancy are significantly more likely to give birth to a child with neural tube defects or other birth defects. Researchers have linked Depakote to sixteen major types of birth defects, including spina bifida and anencephaly.
According to studies reviewed by the FDA, women who used Depakote while pregnant were nearly four times more likely to give birth to a child with major birth defects than women who used another epilepsy drug. Depakote-related birth defects include neural tube defects, craniofacial defects, heart defects and malformations of other body parts.
The FDA’s Depakote warning also cautioned specifically about the risk of neural tube defects—including spina bifida and anencephaly—associated with use of the drug. The agency stated that women who used Depakote during the first 12 weeks of pregnancy were 75-times more likely to give birth to a child with neural tube defects than the general population.
Based on these findings, the FDA advised doctors to consider forms of treatment other than Depakote for women who may become pregnant. The agency also advised women to use effective birth control while taking Depakote due to the high risk of birth defects associated with the drug.
If you or a loved one used Depakote while pregnant and gave birth to a child with neural tube defects or other side effects, you may qualify to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.