Depakote

Depakote or valproate semisodium or divalproex is a drug to treat manic episodes or bipolar disorders. According to the Food and Drug Administration there are many dangerous side effects of Depakote that involve the unborn Fetus. One of the more serious side effects is Spina Bifida. Spina Bifida is a spinal column injury and the issue is that the spinal column does completely enclose the spinal cord. Living with Spina Bifida can be an extremely difficult experience. The symptoms can include: paralysis, absence of skin sensation, poor or no control over the bowels, scoliosis and spinal lesions (this is by no means an exhaustive list).

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.

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 begin_of_the_skype_highlighting 800-FDA-1088 end_of_the_skype_highlighting begin_of_the_skype_highlighting 800-FDA-1088 end_of_the_skype_highlighting.

Thomas & Wan have represented hundreds of individuals by the side effects of well known drugs including Vioxx, Avandia, Baycol, Zicam and others. 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 contact us today.