Important information– Depakote® has been linked to an increase in the risk for birth defects. An FDA warning in June 2011 included information about Depakote® side effects and pregnancy, supported by alarming data.
Depakote® (divalproex sodium) is an anti-seizure medication that has been available on the U.S. market since 1978. It was later approved by the FDA for the treatment ofmigraine headaches and for bipolar disorder.
Depakote® and Pregnancy
It was known as far back as 2001, when a study in the respected New England Journal of Medicine showed that Depakote® taken during pregnancy causes serious birth defects. In fact, over one in five babies born to mothers who were treated with anticonvulsant drugs such as Depakote® suffered congenital (i.e., present at birth) defects, according to the study.
Types of Birth Defects Linked to Depakote®
There are several types of birth defects that are believed to be linked to Depakote®, including:
- spina bifida and other neural tube defects
- iniencephaly, the baby’s head is severely bent toward the spine
- hyraencephaly, here, the cerebral hemispheres did not form; cerebrospinal fluid fills the skull
- craniofacial (skull and face) defects, such as craniosynostosis (the skull closes prematurely) and cleft palate
- cardiovascular malformations such as atrial septal defects (holes in the heart)
- extra fingers and/or toes
Depakote® and Common Birth Defects
The FDA requires a “black box warning” (the most severe type of warning) on Depakote®’s packaging, but many critics have contended that Depakote® shouldn’t be on the market at all, in light of how many babies it has harmed. For example, the rate of neural tube defects in babies of mothers in the U.S. who haven’t taken any drugs during pregnancy is about 1 in 1,500, whereas the same rate among newborns of Depakote®-treated mothers in 1 in 20.
If you are taking Depakote® and are of the child bearing age, you should consult your doctor about the birth defect risk. If you are pregnant or are thinking of becoming pregnant, talk to your doctor about your options right away.
Don’t Delay! Call Clay!
If you have concerns about a baby born with a birth defect, whether linked to Depakote® or not, please be assured that you can consult us for a no-cost discussion of your circumstances. Don’t delay! Call Clay! Our experienced staff members are here to help.