The FDA uses a letter system to identify drugs which may have possible negative effects on the fetus of a pregnant woman, as well as during lactation.
This helps doctors and soon-to-be mothers weigh the risk and benefits of using a drug during pregnancy.
It also aids in minimizing the number of children who suffer birth defects related to the use of potentially dangerous drugs during pregnancy.
The categories include A, B, C, D and X, with “A” meaning that studies have failed to demonstrate a risk to the fetus, to those drugs labeled “X” meaning that studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Cognitive Problems and Physical Birth Defects Associated with the Use of Depakote
Published studies suggest that valproate drugs may increase the risk of cognitive problems (such as decreased IQ scores, autism and Asperger’s syndrome) and physical birth defects (such as spina bifida, atrial septal defect, cleft palate, hypospadias, extra fingers or toes and craniosynostosis) in babies exposed during pregnancy.
For example, in April, 2013, the Journal of the American Medical Assn. (JAMA) published a study, “Prenatal Valproate Exposure and Risk of Autism Spectrum Disorders and Childhood Autism,” (JAMA, 2013; 309(16); 1696-1703, Christensen, et al).
This study concluded that “maternal use of valproate during pregnancy was associated with a significantly increased risk of autism spectrum disorder and childhood autism in the offspring, even after adjusting for maternal epilepsy.”
In a safety communication dated 05/06/13, the U.S. Food and Drug Administration (FDA) advised health care professionals and women that the anti-seizure medication valproate sodium and related products are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches.
The FDA also raised the pregnancy category for valproate medicines used to prevent migraine headaches from category “D” (meaning that the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to “X” (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).
If you used or may have used a valproate product while pregnant and your child was diagnosed with any of the following birth defects, you may be entitled to recover compensation:
- Decreased IQ scores
- Autism
- Asperger’s syndrome
- Pervasive developmental disorder (PDD)
- Rett’s disorder (Rett syndrome)
- Childhood disintegrative disorder (CDD)
- Spina bifida
- Atrial septal defect
- Cleft palate
- Hypospadias (a birth defect involving the male urethra)
- Extra fingers or toes
- Craniosynostosis (a birth defect involving a baby’s skull)
Our Depakote Attorneys Protect the Rights of Families Affected by Birth Defects
According to the FDA, last year approximately 1.5 million patients received these anti-seizure medications, with roughly 22% (341,000) being women between the ages of 13 to 45 years.
If you, your wife or a loved one used Depakote or a related drug and this caused a child to develop one of the cognitive problems or physical birth defects listed above, contact the Depakote attorneys.
You can call the firm toll free at (419) 827-3194 or online by submitting the free case evaluation form found of this page.
Zoll & Kranz has worked on behalf of individuals and their families affected by dangerous medications since 1988.
This includes their work representing women prescribed selective serotonin reuptake inhibitors (SSRIs) while pregnant, which has also been linked to birth defects in children.
