Anti-Seizure Drug Depakote Linked to Cognitive Problems and Physical Birth Defects
Published studies suggest that valproate medications including, Depacon, Depakote, Depakote CP, Depakote ER, Depakene and Stavzor, 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 to valproate products during pregnancy.
Valproate products are approved to treat seizures, manic or mixed episodes associated with bipolar disorder, and to prevent migraine headaches.
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).
Recently, 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). The 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.”
ZKB Law 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. For more information, contact ZKB Law by calling toll free at (888) 841-9623
or online at www.zkblaw.com.
Zoll, Kranz & Borgess, LLC – Medical Drug and Device Attorneys