Children born to women who took the epilepsy drug valproic acid (Depakote or Depakene) during their pregnancy’s first trimester are more than 2.5 times more likely to have serious births defects. These injuries can affect the brain, heart and limbs, according to a study published in the New England Journal of Medicine.
Serious Depakote birth defects include:
◆ Cleft palate
◆ Hypoplastic right heart (underdeveloped right side)
◆ Undescended testes
◆ Hand malformations
◆ Dysplastic (abnormally developed) ribs
◆ Hypospadia (male baby’s urethra opening occurs in wrong place)
◆ *Spina Bifida (spinal column fails to enclose spinal cord)
◆ Fetal death
*Among the most severe side effects, spina bifida is a birth defect in which the spinal cord and backbone fail to develop or close properly. The risk of spina bifida in the offspring of mothers taking valproic acid during pregnancy is 1 – 2 percent, while a recent study found babies subjected to their mothers’ use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida compared to babies whose mothers did not take the drug.
Contact an experienced drug injury lawyer to file a Depakote Lawsuit if you or someone you love suffered birth defects as a result of Depakote.
Spina bifida Injuries
Lolkje T.W. de Jong-van den Berg and colleagues at the Netherlands’ University of Groningen found babies subjected to their mothers’ use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida than babies whose mothers never took the drug.
Babies whose mothers took valproic acid were also 2.5 times more likely to have an atrial septal defect (heart), about five times as likely to have a cleft palate (upper lip and roof of the mouth) or hypospadias (abnormal penis), more than twice as likely to be born with an extra hand digit (polydactyly), nearly seven times more likely to have craniosynostosis (premature skull fusion restricting skull, brain growth).
While valproic acid was associated with a higher relative risk of the six birth defects, researches noted the absolute risk of having a baby with any of the defects remains small. For example, the risk of a baby’s having spina bifida was 0.6 percent – or six in 1,000 – among women who took the drug, compared to five in 1,000 of babies born to mothers who didn’t.
But given mounting evidence of the risks of valproic acid to fetuses, researchers urged women of childbearing age to try other drugs to control their seizures.
“These findings provide further evidence to avoid valproic acid, if possible, in pregnant women and (for doctors) to discuss with girls and women of childbearing potential the risk of the drug for the unborn child,” van den Berg said.
Depakote not a first-line Drug
Dr. Kimford Meador – a professor of neurology at Emory University in Atlanta – echoed that warning: “This drug should not be used as a first-line drug for epilepsy in women of childbearing age. (There) are multiple types of malformations that can be associated with valproic acid.”
The review was published in the June 10, 2010 issue of the New England Journal of Medicine (NEJM).
Researchers first looked at eight studies that included nearly 1,600 births and identified some 14 birth defects that seemed to be much more common among the children of women who took valproic acid early in pregnancy.
Armed with that information, researchers analyzed data from a large European study that included nearly 4 million births and 98,000 birth defects. They found women who took valproic acid in early pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs. The findings were similar when birth defect rates among those taking valproic acid were compared to the rates for women who took other epilepsy drugs, leading researchers to conclude it was the valproic acid, not some other epilepsy drug, that was to blame.
Among those who took valproic acid during early pregnancy, the chances of having a baby with any of the defects was less than 1 percent — cleft palate (0.3 percent), hypospadias (0.7 percent), polydactyly (0.2 percent), craniosynostosis (0.1 percent).
Previous research has also linked valproic acid to spina bifida, other birth defects, cognitive problems in children, Meador noted. In April 2009, Meador was lead author of a study that appeared in NEJM linking exposure to valproic acid in the womb to lower IQ scores in children.
The American Academy of Neurology recommends pregnant women avoid valproic acid, according to background information in the publication. Yet because roughly half of pregnancies are unplanned, according to the study, researchers said all women of childbearing age should be warned about the dangers.
Despite such concerns, Meador said valproic acid is often still prescribed. In 2006, valproic acid was the second most commonly prescribed epilepsy drug. Meador added that Valproic acid is also prescribed to prevent migraines and to treat bipolar disorder.
Meador also said that despite the risks, valproic acid can be a very effective drug and may be the best choice for some patients whose seizures are not well-controlled by other medications.
Reuters was the source for much of this story.