For expectant mothers taking Depakote, spina bifida is a risk for your unborn child
If you are expecting a child and are taking Depakote, there is a serious risk of your child developing spina bifida. Depakote (Valproic acid,) in the form of divalproex sodium, is an active ingredient in the anti-epileptic drug Depakote, and valproic acid has been linked to serious birth defects. Of all of the potential birth defects, unborn children are at greatest risk of developing Spina bifida.
Depakote's known side effects include nausea, weight gain, hair loss and the potential for worsened seizures/ worsened depression. (1) Among the birth defects associated with valproic acid drugs (Depakote among them), spina bifida is the ailment unborn children are most likely to suffer, according to a 2010 study. (2)
There is a relationship between Depakote usage in the first trimester and the fetus' development of spina bifida, and the FDA has issued a warning to pregnant women and their healthcare providers informing them of this relationship. (3)
Weitz & Luxenberg have been helping patients and their families for over twenty years. Risk to a patient's health and life is unacceptable, and risk to unborn children is completely unacceptable. Read on to learn more about the risks pregnant Depakote users face, and more specifically, the risks their children face.
What is spina bifida?
Spina bifida means "cleft spine." The condition is “characterized by the incomplete development of the brain, spinal cord, and/or meninges (the protective covering around the brain and spinal cord). It is the most common neural tube defect in the United States - affecting 1,500 to 2,000 of the more than 4 million babies born in the country each year.” (4)
There are four types of spina bifida, listed in order of severity: occulta, closed neural tube defects, meningocele, and myelomeningocele. Occulta is the mildest and most common form in which one or more vertebrae are malformed. The opening in the spine is covered by a layer of skin. Spina bifida occulta rarely causes disability or symptoms. (4)
A person suffering from closed neural tube defects can have one or more of a group of spinal defects in which the spinal cord has malformations made of fat, bone, or membranes. Some patients suffer few or no symptoms; in others the malformation causes incomplete paralysis with urinary and bowel dysfunction. (4)
When a person suffers from meningocele, their meninges protrude from the spinal opening, and the malformation may be covered by a layer of skin. Some patients have few or no symptoms; others may experience incomplete paralysis with urinary and bowel dysfunction. (4)
Myelomeningocele occurs when “the spinal cord is exposed through the opening in the spine, resulting in partial or complete paralysis of the parts of the body below the spinal opening. The paralysis may be so severe that the affected individual is unable to walk and may have urinary and bowel dysfunction.” (4)
Studying valproic acid in Depakote: spina bifida is the greatest risk
Dr. Janneke Jentink and a team of fellow researchers published a paper in The New England Journal of Medicine in June of 2010 entitled “Valproic Acid Monotherapy in Pregnancy and Major Congenital Malformations.” The doctors came to the conclusion that “the use of valproic acid in the first trimester was associated with significantly increased risks of several congenital malformations, as compared with no use of anti-epileptic drugs or with use of other anti-epileptic drugs.” (2)
The team found “significant associations between exposure to valproic acid monotherapy in the first trimester (as compared with no exposure to antiepileptic drugs) and six of these conditions: spina bifida, atrial septal defect, cleft palate, hypospadias, polydactyly, and craniosynostosis. Risks for five of these conditions were 2 to 7 times as high for exposed fetuses, and the risk for the sixth condition, spina bifida, was 12 or 16 times as high.” (2)
Took Depakote? Spina bifida affecting your child's life? There is legal help.
An anti-epileptic drug, anti-depressant, or anti-migraine medication should not endanger your life with liver and pancreatic damage, and it should not harm your child with congenital malformations like spina bifida. If you have been harmed by your usage of Depakote, there is legal help.
Contact Weitz & Luxenberg at 1-800-476-6070, or by filling out a form, for your free legal consultation.
Was Depakote Recalled? Learn about the Depakote recall in 2006 and 2009, and other Depakote FDA news
the FDA did not recall Depakote, but it did issue a warning to avoid taking it during pregnancy due to the risk of birth defects such as spina bifida.
Birth Defects The FDA warned of Depakote birth defects in 2009
Depakote has been linked to birth defects including spina bifida. If you took Depakote while pregnant, and your child has a birth defect, we can help.
Depakote Have you or your child experienced Depakote side effects?
Depakote is associated with several side effects. However, if you took Depakote while pregnant, you child could be at risk for birth defects.