For children whose mothers took Depakote, birth defects risks are high, FDA admits

In the Food and Drug Administration's December 2009 MedWatch Safety Alert, the government group issued recommended that pregnant women taking Depakote and related drugs “contact their health care professionals immediately,” but did not recall the drug. (1)

In their warning, the FDA recommended that

• Women who are planning a pregnancy or who become pregnant while taking valproate [the active drug in Depakote and similar drugs like Depacon, Depakene and Stavzor] should contact their health care professionals immediately.
• Valproate should not be stopped without talking to a health care professional, even in pregnant women. Stopping valproate suddenly can cause serious problems.
• Women who may bear children should only use valproate if it is necessary to manage their medical condition. Talk to your health care professional about the risks and options if you use valproate and you may become pregnant.
• Women who use valproate and are not planning to get pregnant should use effective birth control.
• Pregnant women who use valproate or other drugs to treat epilepsy should consider enrolling in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or visitingwww.aedpregnancyregistry.org. (1)

If you are pregnant and take Depakote or a similar drug, you should contact your doctor immediately. When you have finished reading about the relationship between Depakote and birth defects, you may want to consult a lawyer as well. Weitz & Luxenberg have been helping people harmed by defective drugs and medical devices for over twenty years, and we hope we can be a resource to you.

What are the Depakote birth defects risks?

The government reported “an increased risk of neural tube defects, such as defects of the brain and spinal cord, and other major birth defects, such as craniofacial defects (abnormally formed face and skull enclosing the brain) and cardiovascular malformations (abnormally formed heart or blood vessels), in babies exposed to valproate sodium and related products during pregnancy.” (1)

The most common neural tube defect of the brain and spinal cord is spina bifida, a condition “characterized by the incomplete development of the brain, spinal cord, and/or meninges (the protective covering around the brain and spinal cord).”(2)

A 2010 study on the relationship between valproic acid monotherapy (i.e. taking drugs like Depakote alone) found“significant associations between exposure to valproic acid monotherapy in the first trimester (as compared with no exposure to antiepileptic drugs) and six of these conditions: spina bifida, atrial septal defect, cleft palate, hypospadias, polydactyly, and craniosynostosis. Risks for five of these conditions were 2 to 7 times as high for exposed fetuses, and the risk for the sixth condition, spina bifida, was 12 or 16 times as high.” (3)

Among the many conditions unborn children whose mothers had been prescribed Depakote, spina bifida was the most common risk.

Depakote birth defects are not an acceptable risk

Though Depakote and other anti-epileptics were designed with the intention of improving your health—whether in the treatment of epilepsy, bipolar disorder, migraines, or off-label uses. But the risk of liver damage in users, and the risk of birth defects in Depakote users' unborn children, run counter to the drug's purpose of bettering your health.

If you or your child have been affected by Depakote, which came on the market in 1983 and became available in generic form in 2008, you are not alone. If you are considering taking legal action, contact Weitz & Luxenberg for a free legal consultation at 1-800-476-6070, or by filling out a form.

Acknowledgments:

1.http://www.fda.gov/ForConsumers/ConsumerUpdates
/ucm196683.htm#BirthDefectsRelatedtoDepakoteandSimilarDrugs

2.http://www.medicinenet.com/spina_bifida_and_anencephaly/article.htm#tocc

3. http://www.ncbi.nlm.nih.gov/pubmed/20558369

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