The U.S. Food & Drug Administration (FDA) notified healthcare professionals and patients that using valproic acid and divalproex sodium products such as Depakote, an anticonvulsant typically prescribed for migraines, seizure disorders and manic episodes associated with bipolar disorder, carries an increased risk of birth defects. This is not the first warning the FDA has issued.

Depakote birth defects

The FDA warned healthcare professionals and patients about the increased risk of neural tube defects and other major birth defects such as craniofacial defects and cardiovascular malformations in babies exposed to valproic acid and divalproex sodium products such as Depakote during pregnancy. In fact, the FDA warned doctors that the risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy – and may affect a staggering 1 in 20 babies. Unfortunately, it is not the first warning the FDA has issued.

Black box warning issued in 2006

The latest warning comes after the FDA issued a black box warning in 2006 concerning neural tube defects such as Spina Bifida, hepatic (liver) failure and pancreatitis:

• Neural tube defects: Depakote can produce neural tube defects and it is recommended that the benefits of Depakote use in women of childbearing age be weighed against the potential risks to unborn fetuses.
• Hepatic failure: Children under the age of two years are at increased risk of hepatic failure in some circumstances and that parents should consult with their child's pediatrician to determine if the benefits outweigh the risks.
• Pancreatitis: Pancreatitis in adults and children have been reported directly after use to several years after use. Symptoms of pancreatitis include abdominal pain, nausea, vomiting and/or anorexia.

Studies show Depakote's dangers

Numerous studies have shown that Depakote is dangerous. The New England Journal of Medicine reported that children born to mothers who took Depakote while pregnant had lower I.Q.s and the British Journal of Clinical Pharmacology reported that mothers who were given folate-blocking and folate-lowering drugs while pregnant were six times as likely to develop Spina Bifida and brain defects and were twice as likely to develop neural tube, cardiovascular and urinary tract birth defects.

If you or your baby has been injured after using Depakote, consider contacting an experienced Depakote injury attorney to discuss your situation. You may be entitled to compensation for past and future payment of medicals, lost wages and pain and suffering. However, it's important not to delay as each state has its own statute of limitations in which to file a product liability lawsuit – and once that time limit expires, you may be barred from doing so in the future.