Research Found Depakote Birth Deffect. In a lawsuit filed against Abbott Laboratories, the family of a girl born with spina bifida alleges that the anti-epilepsy drug Depakote caused the child’s birth defect.
On October 19, United States District Judge Nancy Rosenstengel dismissed Abbott’s motion to drop the lawsuit based on the statute of limitations. The judge’s opinion said, “it is undisputed that the Illinois statute of limitation does not bar the current claim.” Illinois laws allow minors to seek damages at any time and up to two years after they turn 18, allowing the complaint against Abbott to go forward for now. Parker Waichman notes that research has found that Depakote use during pregnancy is linked to a number of birth defects.
The girl Emily, now 12, underwent open fetal surgery to treat the spina bifida while she was still in the womb. At the time, Emily’s mother was only the nineteenth patient to undergo such surgery at Vanderbilt University Medical Center. Though Emily can walk on her own, she sometimes uses a wheelchair. “Emily’s muscles will never be able to gain full strength and she tires easily,” the hospital’s website explains.
Spina bifida is a neural tube defect. Normally, the neural tube forms early in the pregnancy and closes by the 28th day after conception, the Mayo Clinic explains. In babies with spina bifida, however, a portion of the neural tube fails to develop or close properly, causing defects in the spinal cord and in the bones of the spine. Spina bifida has various degrees of severity. Symptoms can include:
- muscle weakness of the legs, sometimes involving paralysis
- bowel and bladder problems
- seizures, especially if the child requires a shunt
- orthopedic problems such as deformed feet, uneven hips and a curved spine (scoliosis)
Treatment for spina bifida is done surgically, although surgery does not always completely resolve the problem.
Although the exact causes of spina bifida are not known, the condition seems to be the result of genetic and environmental risk factors, such as a family history of neural tube defects and folic acid deficiency. The lawsuit filed by Emily’s family alleges the anti- Depakote is responsible for Emily’s spina bifida. Abbott Labs does not deny that Depakote poses a danger to pregnant women but the drug maker argues that the mother should have known about the risks in 2004 when she was pregnant.
Depakote is used to treat epilepsy and also used to treat other bipolar disorder and migraines. Brand names for valproate include Depakote, Depakene, Depacon, and Stavzor.
In 2009, the Food and Drug Administration (FDA) warned that the risk of neural tube defects in babies whose mothers who took Depakote during pregnancy is “much higher” than average, or 12.5 times worse. The FDA has also warned of the risk of “impaired cognitive development” in children whose mothers took Depakote during pregnancy. Since migraines are generally not a life threatening condition, the FDA advises that pregnant women should not take valproate.
For pregnant women with epilepsy or bipolar disorder, valproate products should be prescribed only if other medications are not effective in treating the condition or are otherwise unacceptable. Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder. A category D drug is one for which the potential benefit of the drug in pregnant women may be acceptable despite its potential risks. Valproate’s pregnancy category for migraine use was changed to X, meaning that the risk clearly outweighs any possible benefit of the drug.
Six Birth Defects Linked to Valproate
A 2010 study published in the New England Journal of Medicine reports that six birth defects were more common among children of women who took valproate during the first trimester than children of women who did not take antiseizure drugs. The birth defects are spina bifida, atrial septal defect (a hole in the heart), cleft palate, hypospadias (abnormality in the opening of the urethra in boys), extra fingers or toes, and craniosynostosis (sutures on a baby’s skull close prematurely).
The researchers conclude that the “findings provide further support for the recommendation of the American Academy of Neurology to avoid the use of valproic acid, if possible, in pregnant women.”