Depakote, also known as valproate semisodium or divalproex sodium, is mainly used to treat bipolar disorder. In some cases, Depakote is also used to treat major depressive disorder, epilepsy, chronic pain associated with neuropathy, and migraine headaches. Depakote has been shown to lead to ten times the risk of birth defects in pregnant women than other similar drugs. A higher dosage of the drug leads to a higher risk of birth defects.

Severe Depakote Side Effects

Depakote leads to severe birth defects such as:

• Spinal Bifida: In the general population, spinal bifida occurs in fewer than one in one thousand births. However, pregnant women on Depakote have a significantly higher risk of spinal bifida. Spinal bifida occurs when some vertebrae of a baby's spine do not fuse completely and the spinal column does not completely develop. This condition usually results in disability.
• Cardiovascular Problems: Some heart defects that may result from taking Depakote include coarctation of the aorta (narrowing of the aorta) and hypoplastic right heart (underdevelopment of the right side of the heart).
• Cleft Palate: This defect occurs when the two palates of the skull that form the roof of the mouth are not completely joined.
• Learning Disabilities In June 2009, FDA researchers requested that the agency take a closer look at the relationship between Depakote and developmental delays in children born to mothers who took the drug while pregnant. The FDA had identified at least six cases of children born with developmental delays, several of whom developed autism.

Depakote has a history of being a problematic drug, prompting the FDA to issue numerous safety alerts modifying its warning label. In September 2000, the FDA required Depakote's first black-box warning due to reports of life-threatening pancreatitis from users of the drug. In January 2007, the FDA issued another warning revising Depakote's label due to its risk of causing severe birth defects in pregnant women. In May 2009, the FDA issued yet another safety alert due to the use of Depakote being potentially associated with an increase in suicidal behavior or thoughts about suicide. Depakote's label was again changed to accommodate this new risk.

Contact our Experienced Attorneys

The lawyers at the Pintas & Mullins Law Firm have extensive knowledge about drug litigation. If you or a loved one has had a baby with birth defects and you believe Depakote may have caused this, contact our office immediately. Each drug case is unique, and most have a specific time frame in which you can file a lawsuit. Our law firm can provide you with a free no-obligation consultation and explain your legal rights.

Resource Links:

FDA Warning Regarding Suicide Risk and Depakote
Visit this link to read more about the FDA warning of the increased risk of suicidal behavior or thoughts from Depakote.

MedPage Today: Depakote and Increased Incidence of Birth Defects
Visit this link to read more about Depakote and the increased incidence of birth defects in children borne by women who have taken the drug during pregnancy.