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FDA Issues New Boxed Warning for Depakote, Depakene, and Depacon

Filed July 16th, 2013 Laurie

The U.S. Food and Drug Administration (FDA) has added a boxed warning label to the drugs Depakote, Depakene, Depacon, all of which contain valproate. A boxed warning is the most serious warning the FDA can apply to a medication. Depakote and valproate-containing drugs are used to treat seizures, migraines, and bipolar disorder.

The boxed warning states that Depakote can lower IQ scores and cause serious congenital malformations, such as neural tube defects, like spina bifida, in which the spinal cord does not close properly. Depakote can also cause other spinal cord and backbone problems.

According to the warning, Depakote and valproate-containing drugs should not be prescribed to women of childbearing years unless it is absolutely vital to the management of their medical condition. They should also not be given to pregnant women or women who are planning to become pregnant who suffer from epilepsy unless all other treatment options have failed.

The results of a 2010 study published in the New England Journal of Medicine showed that Depakote was linked to cleft palate, polydactyly (extra fingers or toes), craniosyntosis, spina bifida, atrial septal defect (a hole in the heart), and hypospadias (an abnormal opening in a boy’s urethra).

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