Women who took the anti-epileptic drug Depakote during the first trimester of pregnancy are much more likely to deliver babies with serious birth defects affecting the brain, heart and limbs, according to a study in the New England Journal of Medicine.
Depakote was first approved in the United States by the Food and Drug Administration (FDA) in 1983 as a treatment for epilepsy. In 1995, the FDA approved the use of Depakote to treat mania in bipolar patients. A year later, the drug’s indication was expanded to include the reduction of migraine headaches.
In 2002, the FDA approved Depakote ER for use as adjunct therapy for adults with epileptic seizures. The drug is now available in brand name and generic form from various pharmaceutical companies. An estimated 2.4 million people have used Depakote over the years for both approved and off-label uses.
Over the years, researchers have raised concerns about the birth defect risk with Depakote. What heightens this concern is that many women become pregnant weeks or months before they are aware, and as the latest study cautions, it is in the first trimester that Depakote, which contains valporic acid, can be most toxic to developing fetuses.
Researchers at the University of Groningen in The Netherlands found that fetuses exposed to valporic acid during the first trimester were 12.7 times more likely to have spina bifida than babies who were not exposed to the drug in utero. Spina bifida is a serious neural tube defect that can cause paralysis and disability.
Researchers also found that fetuses exposed to Depakote were 2.5 times more likely to have atrial septal defect, a heart defect; about five times more likely to have a cleft palate or hypospadias, a penis abnormality; more than twice as likely to be born with an extra finger on the hand; and nearly seven times more likely to have craniosynostosis, or premature fusion of the skull during fetal development that restricts brain growth.
Researchers say the study reinforces the importance of educating women of childbearing age about the dangers of Depakote to developing fetuses. They urge women to try other drugs to control their seizures.
Source: Psych Central