Depakote, Similar Epilepsy Drugs Can Up the Risk of Neural Tube, Other Birth Defects

<"">Depakote (valproic acid) and similar epilepsy drugs have been associated with serious birth defects. In 2009, the US Food & Drug Administration (FDA) warned that women of childbearing potential should only use drugs like Depakote if it is essential to manage their medical condition.

In addition to Depakote, valproic acid is marketed under the brand names Depakote ER, Depakene, Depacon, Depakine and Stavzor. In addition to epilepsy, Depakote and similar drugs are used to treat mania (episodes of frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). They are also used to prevent migraine headaches.

Last June, the New England Journal of Medicine (NEJM) published a study that found that Depakote and similar drugs increased the risk of six different birth defects. Researchers led by Janneke Jentink, MSc, of the University of Groningen in Groningen, Netherlands, viewed data from eight studies that highlighted 14 birth defects that were more common among offspring of women who took valproic acid during the first trimester. Next, they identified infants with these 14 birth defects from the European Surveillance of Congenital Anomalies (EUROCAT) antiepileptic-study database, and compared them to a group of infants with birth defects not previously connected to use of this drug and to a group of infants with chromosomal abnormalities.

Six birth defects – spina bifida, atrial septal defect (a hole in the heart), cleft palate, hypospadias (an abnormality in the opening of the urethra in boys), polydactyly (extra fingers or toes), and craniosynostosis (one or more sutures on a baby’s skull close prematurely) – were more common in babies born to mothers who had taken valproic acid in their first trimester of pregnancy.

The NEJM study came just months after the FDA issued its warning regarding the connection between birth defects and drugs like Depakote. At the time, the agency said the risk of neural tube defects occurring was much higher in babies born to mothers treated with one of these medications during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies, the agency said.

The FDA advised women not actively planning a pregnancy to use effective contraception if they are taking Depakote or a similar drug, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. Women who are planning a pregnancy or who become pregnant while taking Depakote or a related medication should contact their healthcare professionals immediately, the agency said.

Finally, the FDA said women who become pregnant while taking epilepsy drugs like Depakote should consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Women can do this by calling the toll-free number 1-888-233-2334. This pregnancy registry gathers information about the safety of antiepileptic drugs during pregnancy.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.