Valproic Acid and Pregnancy

Studies on valproic acid and pregnancy have shown that the drug can possibly cause birth defects in humans. As a result, the FDA considers it a pregnancy Category D medicine. Despite this risk, if a woman is taking valproic acid and pregnancy occurs, her healthcare provider may have her continue it if the benefits to the mother outweigh the risks to her unborn child.

 

Is Valproic Acid Safe During Pregnancy?

Valproic acid (Depakene®) is a medication used to control seizures in people with epilepsy. The medication may not be safe for women who are pregnant. In several studies that looked at the effects of valproic acid during pregnancy, the drug increased the risk of birth defects and other problems.
 

Valproic Acid and Pregnancy Category D

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women, but which may still offer benefits that outweigh these risks. Thus, a pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the mother outweigh the possible risks to the unborn child.
 
Unlike many other medications, valproic acid has been studied in many pregnant women. Several studies have shown that the drug may cause birth defects in humans. Sometimes, these birth defects can be very severe, and pregnant women should not take valproic acid unless absolutely necessary. However, poorly controlled epilepsy can also be dangerous to both the mother and the fetus. You and your healthcare provider must discuss the specific benefits and risks of using the medication during pregnancy in your particular situation. If your epilepsy is mild (or if you have not had a seizure in several years), you may consider stopping valproic acid. However, if your epilepsy is severe or difficult to control, it may be best for you to stay on valproic acid. No matter what, do not stop taking the medication suddenly (see Valproic Acid Withdrawal).
 
If you and your healthcare provider decide that it is best for you to continue taking valproic acid, you will need frequent blood tests to measure your valproic acid levels. Pregnancy can affect the way your body handles the drug, and it is important to keep your dose at the lowest effective level to help protect your fetus). Your healthcare provider may suggest a higher-than-usual dose of folic acid, as this may also help protect the fetus.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;