Depakote Legal Assistance
The Law Firm of Eric H. Weinberg is currently assisting individuals who may have suffered injuries related to Depakote therapy. We are ready to help you. If your child has experienced a Depakote related birth defect due to Depakote exposure during pregnancy, please submit a Free Depakote Lawsuit Evaluation Form, or call us toll free at 1-877-934-6274. We promise to bring our more than 20 years of experience litigating pharmaceutical cases to bear on you behalf.
FDA Cautions That Depakote Increases Risk Of Birth Defects, Including Neural Tube Defects (e.g., Spina Bifida)
The US Food and Drug Administration, FDA, has required Abbott Laboratories to include a “Boxed Warning” alerting doctors and patients to serious and life-threatening side effects, including birth defects, associated with Depakote use. These side effects may include potentially fatal hepatotoxicty, birth defects, and serious pancreatitis. A Boxed Warning is the strongest warning that the FDA can require a company to use in its drug labeling.
However, based on available data concerning valproate related products (including Depakote) and birth defects, the FDA chose to notify health care professionals and patients on December 3, 2009, of the increased risk of major birth defects in infants exposed to these products. Birth defects associated with this increased risk include neural tube defects such as spina bifida, craniofacial defects, cardiovascular malformations, and malformations involving other parts of the body. Neural tube defects, including spina bifida, occur when the developing spinal column does not close properly, leaving the brain and or spinal cord exposed at birth. The FDA also stated that it would work with the manufacturers of these products to address the appropriate labeling changes regarding safety.
As part of the above referenced safety communication entitled Information for Healthcare Professionals: Risk of Neural Tube Birth Defects Following Prenatal Exposure to Valproate the FDA cautioned:
Valproate use during early pregnancy increases the risk of major malformations in the baby.The rates for neural tube defects in babies exposed to valproate during the first trimester are 30 to 80 times higher than the rate for neural tube defects in the general U.S. population. In pregnant women with epilepsy, valproate monotherapy is associated with a four-fold higher rate of major malformations than other antiepileptic drug monotherapies.
Marketed by Abbott Laboratories, Depakote, or divalproex sodium, is a compound made up of sodium valproate and valproic acid. The product is available as a tablet, solution, injectable, capsule, and long acting formulation and is prescribed for the treatment of manic episodes associated with bi-polar disorders, seizure disorders, and for the prophylaxis of migraine headaches. The various formulations are marketed as Depacon, Depakote, Depakote CP, Depakote ER, Depakene, and Stavzor.
Generic Depakote is marketed by Genpharm, Inc; Lupin Limited, Inc; Nu-Pharm, Inc; Sandoz, Inc; Sun Pharmaceuticals; Teva Pharmacruticals; Upsher-Smith Laboratories; and Dr. Reddy’s Laboratories.
What You Should Do If You Suspect A Depakote Side Effect Or Depakote Birth Defect
Consumers and professionals can report suspected Depakote side effects or Depakote birth defects to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm, or by phone 800-FDA-1088.
Obtain A Free Depakote Lawsuit Case Evaluation
The Law firm of Eric H. Weinberg has represented hundreds of individuals and thousands more class action claimants injured by the side effects of well known prescription drugs including Vioxx, Ortho Evra, Baycol, and blood clotting products. If you or your child has suffered an injury that may be related to Depakote use, and would like a free Depakote lawsuit evaluation, please select Depakote Lawsuit Evaluation Form/Depakote Lawyer, or call us toll free at 1-877-934-6274.
To read the entire FDA communication regarding its advice to healthcare professionals and patients, especially women of childbearing potential, please see Risk of Neural Tube Birth Defects Following Depkote Exposure.