Depakote (valporic acid)

Depakote has been found to be create a much higher risk of birth defects than the manufacturer had been claiming in reports to the FDA.

The chemical compound, valproic acid (VPA), is an anticonvulsant and mood-stabilizing drug, primarily used in the treatment of epilepsy, bipolar disorder, and, less commonly, major depression. It is also used to treat migraine headaches and schizophrenia. It is marketed under the brand names Depakote, Depakote ER, Depakene, Depacon, Depakine and Stavzor.

Related drugs include the sodium salts sodium valproate, used as an anticonvulsant, and a combined formulation, valproate semisodium, used as a mood stabilizer and additionally in the U.S. as an anticonvulsant.
FDA warns of birth defects associated with Depakote

The FDA warned in December 2009 that Depakote increases the risk of some severe birth defects in childrern born to women who took the drug during pregnancy.

An FDA MedWatch alert for Depakote stated: “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.”

Anti-seizure medication Depakote can cause birth defects

European researchers say using the antiseizure medication Depakote (valproic acid) in the first trimester of pregnancy can cause any one of six different birth defects.

The risk of the serious spinal defect known as spina bifida increases more than 12 times for children of women on the drug, according to Lolkje T.W. de Jong-van den Berg, of the University of Groningen in the Netherlands and colleagues. The finding is based on an analysis of more than 98,000 pregnancies.

Five other defects also become more common for children born to women taking Depakote. These five defects become 5 to 7 times more likely. The findings are to be published in the June 10 issue of the New England Journal of Medicine.

The American Academy of Neurology recommends women avoid the use of the drug in pregnancy.

The European researchers found that six malformations were significantly linked to a woman’s valproic acid use in her first trimester of pregnancy. In addition to spina bifida, the children of these women faced a more than doubled risk of a heart condition known as an atrial septal defect and a five-fold risk of cleft palate.

The risk of hypospadias — a condition in which the opening of the urethra in boys is on the underside of the penis rather than the end — went up nearly five times with a mother’s use of the drug. Craniosynostosis, a condition in which the bones of the skull close too early, was nearly seven times as common in these children, and polydactyly, a condition in which a child has more than five fingers per hand, was more than twice as common.


Reuters News Service
New England Journal of Medicine