If you have epilepsy, bipolar disorder, manic depression, or suffer from migraine headaches, your physician may have prescribed Depakote®. Depakote®, also known as valproic acid, is produced by Abbot Laboratories and was originally designed for the treatment of epileptic seizures. This medication has also been prescribed for the treatment of migraine headaches, bipolar disorder, and manic depression. Unfortunately, Depakote® was found to cause a series of problems including birth defects and lower IQ in the children of women who took the drug while pregnant.
Problems with Depakote®
In April of 2009, the U.S. Food and Drug Administration (FDA) asked Abbott Laboratories to add information regarding the North American Antiepileptic Drug (NAAED) Pregnancy Registry to the Depakote® drug label. The Antiepileptic Drug Pregnancy Registry at Massachusetts General Hospital is designed to investigate the safety of drugs like Depakote® when taken during pregnancy.
Pregnancy registries help the medical industry gather information they need to help women and expectant mothers make better decisions about drugs they are taking. The success of these registries depends upon consumers like you being aware of the registries, and reporting any pregnancy exposure you’ve had to the registry. We strongly encourage all women exposed to antiepileptic drugs during pregnancy to file a report with the registry by calling toll-free 1-888-233-2334.
Depakote® Black Box Birth Defect Warning
Depakote® was originally approved in 1978 for the treatment of epilepsy. It’s been marketed as Depakene®, Depakote® ER, Stavzor®, and Depakote® Sprinkle, and is also known as divalproex sodium and valproate sodium. Recently Depakote® has been prescribed for less serious conditions such as migraine headaches, and has a history of revisions to labeling related to birth defects. As of 2009 the Depakote® label contains a “black box” warning, the most serious type of warning that can placed on a drug label, regarding teratogenity. It states:
“TERATOGENICITY: VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF DEPAKOTE TABLETS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE WARNINGS, INFORMATION FOR PATIENTS. A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATOGENIC POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS. SOURCE HERE.”
Some mothers who took Depakote® during pregnancy gave birth to babies who suffered birth defects. If this has happened to you or a loved one, you should talk with us. To learn more about Depakote®, why it is used, and some of the consequences it has caused, visit our Lawsuits Information and Complications page.
If you or a loved one have suffered because of Depakote®, or have been injured, you may be entitled to financial compensation. Recovery may include compensations for your medical bills, pain and suffering, and loss of wages. To find out if you have a claim, please call Avram Blair & Associates, P.C. toll-free at (800) 648-2139 or fill out our online contact form for a free consultation.