Fetal Exposure to Depakote, Similar Epilepsy Drugs May Impair Cognitive Development

Valproate medications, including <"http://www.yourlawyer.com/topics/overview/Depakote-Lawsuit-Lawyer-Birth-Defects">Depakote, Depakon, Depakene and Stavzor, may negatively impact a child’s IQ if they are taken during pregnancy. The U.S. Food & Drug Administration (FDA) announced yesterday that it will be revising the labels of all valproate drugs, including Depakote, Depakon, Depakene and Stavzor, along with their generic equivalents, to include information on this risk.

Valproate medications are approved to treat epilepsy, and manic or mixed episodes associated with bipolar disorder and to prevent migraine headaches. They are also used off-label (for unapproved uses) to treat psychiatric conditions and other problems.

In its Drug Safety Communication, the FDA said children born to women who take these medications during their pregnancy “have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.” The FDA is basing its warning on epidemiological studies that showed that fetal exposures to the drugs tended to correlate with lower scores on IQ and other cognitive tests. According to the FDA, information about these findings will be added to the “Warnings and Precautions section” and the “Use in Specific Populations: Pregnancy” section of the drugs’ labels, as well as to the Medication Guides that are being developed for valproate drug products.

The FDA is advising that women of childbearing age taking a valproate drug product be aware that there is a risk of lower cognitive test scores in children exposed to such drugs. Women who become pregnant or are planning a pregnancy should talk to their healthcare professional immediately to discuss whether continued use of valproate is appropriate. Women of childbearing age who decide to continue taking valproate and are not planning to become pregnant should use effective birth control.

Women who are or become pregnant while using a valproate medication should not stop taking the drug, as doing so suddenly can cause serious health problems. Rather, they should call their doctor immediately to discuss the risks and benefits of continued use of this medication, and any possible alternatives, the FDA said.

This is not the first time Depakote and other valproate products have been associated with risks to unborn children. In 2009, the FDA warned that the drugs were associated with an increase risk of neural tube defects. The FDA has placed Depakote and all other valproate products in Pregnancy Category D, which means there is positive evidence of human fetal risk, but potential benefits may still warrant use of the drug in pregnant women.

This entry was posted in Depakote, Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.