If you or a loved one has experienced complications from Depakote, please contact The Law Offices of Edward W. Sampson, PC. today.
Depakote is a prescription medication used to treat seizures, mania associated with bipolar disorder and migraine headaches.
The FDA reported in 2009 that women who take Depakote’s main ingredient, valproate, in the first trimester of pregnancy are 30-80x more likely to have a child with a neural tube defect like spina bifida. Spina bifida results in serious malformations of the spinal cord and backbone, and affected babies often have cognitive disabilities as well.
Combined studies have identified 14 different congenital defects linked to Depakote. The FDA issued a “black box” warning, reserved for side effects likely to cause injury or death, in 2006. But this warning was absent for years.
Depakote FDA Label Change
In April 2009, the FDA Center for Drug Evaluation and Research (CDER) approved a safety label change on certain forms of the drug. The label change contained new information regarding the affiliation of suicidal behavior with Depakote and the danger of using Depakote during pregnancy.
The FDA-approved Depakote label change stated that the use of Depakote and other AEDs may increase the risk of suicidal thoughts or behavior. The label change noted that pregnant women taking Depakote should enroll in the North American Antiepileptic Drug Pregnancy Registry.
Depakote Lawsuit Information
If you or a loved one has experienced adverse side effects from the use of Depakote, you may qualify for compensation to help with the cost of your medical expenses, as well as your pain and suffering. To contact a Depakote lawyer for a free consultation and Depakote lawsuit information, call The Law Offices of Edward W Sampson, PC at 214-880-7789.
Depakote FDA Black Box Warnings
The FDA warns consumers that Depakote has been linked to
- Liver damage and liver failure
- Birth Defects such as spina bifida and neural tube defects
- Pancreatitis or inflammation of the pancreas
Fast Facts about Depakote:
- Goes by the generic names of divalproex sodium
- Contains the active ingredient divalproex sodium
- Was originally approved March 10, 1983
- Is manufactured by Abbott Laboratories
- Is approved for treatment of seizures, mania related to bipolar disorder, and migraine headaches.