Epilepsy Drug Birth Defects Lead to New Guidelines for Pregnant Women

According to new guidelines issued by the American Academy of Neurology and American Epilepsy Society, pregnant women should avoid taking the drug valproate, which could include Depakote, Depacon and several generic versions. The risk of valproate birth defects appears to outweigh the benefits provided by taking the drug during pregnancy, which is usually a safe time for most women with epilepsy.

Studies have established that valproate side effects could increase the risk of birth defects like cleft palate and spinal bifida. Use of the drug has also been linked to lower IQs in children when compared to babies exposed to other epilepsy drugs during pregnancy.

The new guidelines were presented Monday by a panel of experts at the annual meeting for the American Academy of Neurology in Seattle and published online in the journal Neurology.

Approximately 500,000 women in the U.S. who are of childbearing age have epilepsy and about 3 to 5 out of every 1,000 births are to women with epilepsy.

The panelists suggested that pregnancy is relatively safe for women with epilepsy, but they recommended that women avoid taking valproate due to the risk of birth defects, and indicate that they may also want to avoid taking phenytoin (Dilantin) and phenobarbital, which have also been associated with children having lower IQs.

The guidelines also recommend that women should avoid taking more than one anti-epileptic drug at the same time, have their blood tested regularly to adjust any medications for the risk of seizures, take at least 400 micrograms of folic acid every day and avoid smoking during the pregnancy.

Valproate is sold under the brand name Depacon and as a generic by several different manufacturers. The popular antiepiletic drug Depakote (divalproex sodium) is a tablet that becomes valproate once it is in the body and has been associated with the same risks.

In October 2006, the warning label was updated for possible Depakote birth defects associated with taking the drug during pregnancy. The warning was added after a study published in the August 2006 issue of Neurology found that approximately 20.3% of babies born after the mother took Depakote suffered serious adverse outcomes, compared with other drugs that had lower rates between 1% and 10.7%.