Depakote (generic: divalproex) is used to treat certain types of seizures and convulsions. It can be prescribed alone or with other epilepsy medications. Depakote is manufactured by Abbott Laboratories and gained FDA approval in 2000. On May 3, 2007, doctors reported that expectant mothers with epilepsy who took Depakote to control seizures were at increased risk of having a child with mental deficits.
Toddlers who had been exposed in the womb to Depakote, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study discovered. They were twice as likely to score in the range associated with mental retardation, according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston. The report is consistent with several new studies finding that Depakote is more likely than other so-called anticonvulsant drugs to increase the risk of mental deficits and other birth defects, like neural tube problems.
Recently, the U.S. Food & Drug Administration (FDA) released a staement that Depakote and other related drugs must carry new warning labels that children exposed to these drugs during gestation have an increased risk of cognitive development impairment.
Depakote looks worse than the other drugs in all of these recent studies said Dr. Kimford J. Meador, a professor of neurology at the University of Florida and the lead author of the new study. This is compelling evidence that this drug should not be used as a first-line choice for treatment in pregnant women. The drug’s label currently states that Depakote has been associated with birth defects in children of women who have taken it while pregnant.
If you are a woman with epilepsy and have had a child with a birth defect, your epilepsy treatment might be to blame. Depakote, and several other valproic acid-based medications, including Depakene, Depacon, and Stavzor have been associated with a higher risk of six different birth defects. Pregnant women are being warned not to take these drugs to treat their epilepsy if at all possible.
The birth defects associated with a valproic acid-based products like Depakote include spina bifida, atrial septal defect (a hole in the heart), cleft palate, hypospadias (an abnormality in the opening of the urethra in boys), polydactyly (extra fingers or toes) and craniosynostosis (one or more sutures on a baby’s skull close prematurely). Our Depakote birth defect lawyers know how devastating these conditions are, and they are committed to making sure the makers of these drugs are held accountable for the injuries they’ve caused.
Our Depakote birth defect lawyers are investigating the link between valproic acid and birth defects. If you gave birth to a child with a congenital abnormality and took Depakote, Depakene, Depacon or Stavzor, we want to hear from you today. You and your child may be entitled to compensation. Please call us at 1-800-YOURLAWYER(1-800-968-7529) as soon as possible to arrange for a free lawsuit consultation.
Valproic Acid and Birth Defects
The U.S. Food and Drug Administration (FDA) approved valproic acid, sold as Depakene and later as Stavzor, in 1978 for the treatment of epilepsy. Other valproic acid-based drugs include dilvalproex sodium, marketed as Depakote, Depakote CP, Depakote ER, and valproate sodium, sold as Depacon. More recently, the FDA approved valproate for the treatment of bipolar disorder and migraine headaches.
The link between valproic acid-based drugs like Depakote and birth defects has been known about for some time. In December 2009, the FDA warned that valproate and related medications had been associated with a higher risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, when taken by pregnant women.
Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry found that the risk of giving birth to a child with a neural tube defect was 1-in-20 for women who took valproate during the first 12 weeks of pregnancy. The risk for mothers not taking valproate was 1 in 1,500 in the U.S. The NAAED Registry also reported that more than 10% of women who took an average of 1,000 mg per day of Depakene or Stavzor during pregnancy gave birth to children with some kind of major malformation.
In a reminder to health care providers, the agency said women of childbearing potential should only use valproate and related products if it is essential to manage their medical condition. At the time, the agency said it would be working with the manufacturers of valproate products to address labeling changes related to the birth defect risk.
The study from the Netherlands, published in the June 10, 2010 edition of the New England Journal of Medicine, involved data from eight studies that highlighted 14 birth defects that were more common among offspring of women who took valproic acid during the first trimester. Next, researchers identified infants with these 14 birth defects from the European Surveillance of Congenital Anomalies (EUROCAT) antiepileptic-study database, and compared them to a group of infants with birth defects not previously connected to use of this drug and to a group of infants with chromosomal abnormalities.
Six birth defects spina bifida, atrial septal defect cleft palate, hypospadias, polydactyly, and craniosynostosis were more common in babies born to mothers who had taken valproic acid in their first trimester of pregnancy.
The risk of the serious spinal defect known as spina bifida was increased more than 12 times for children of mothers on the drug. The risk of hypospadias went up nearly five times with a mother’s use of the drug. Craniosynostosis was nearly seven times as common in these children, and polydactyly was more than twice as common. When compared with other epilepsy drugs, valproic acid increased the risk for all of these birth defects except craniosynostosis, the study showed. It also showed an increased risk of ventricular septal defect (a hole in the heart) when compared to other epilepsy drugs.
The study authors point out that the actual frequency of specific birth defects were relatively small, all ranging below one percent. That compares to an overall rate of all birth defects of about 2 percent in the general population. The study was observational, so it could not indicate anything about cause and effect. The researchers were also unable to conclude anything about possible confounding by indication, since the drug is used for several clinical indications, or the effects of varying dosages.
Nevertheless, the authors of the study said the findings present further evidence that these drugs should not be used to treat pregnant women when at all possible. Our 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, they wrote. Since switching drugs during or just before pregnancy is difficult, the risks associated with valproic acid use should be routinely considered in choosing therapy for women with childbearing potential.
Legal Help for Victims of Depakote Birth Defects
If you were treated with Depakote, or a similar drug including Depakene, Depacon or Stavzor, and gave birth to child with spina bifida or some other birth defect, you have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our Depakote birth defects lawyers today.