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 (when used for epilepsy or bipolar disorder) and a pregnancy Category X medicine (when used for migraine headaches). If you are taking valproic acid and pregnancy occurs, consult your healthcare provider.
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 Categories D and X
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. Valproic acid is in pregnancy Category D when used for the treatment of epilepsy or manic episodes associated with bipolar disorder (please note that valproic acid is officially approved only for the treatment of epilepsy).
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.
Valproic acid is in pregnancy Category X when used for the prevention of migraine headaches (which is an unapproved use for the drug). Pregnancy Category X means that the risks of taking the medication during pregnancy clearly outweigh the benefits. Medications in this category should not be taken by women who are pregnant or planning on becoming pregnant. Women who are taking valproic acid for this reason and become pregnant or plan on becoming pregnant should contact their healthcare provider before stopping the medication, as this medication should not be stopped abruptly.
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.
Studies have also shown that children born to women who took valproate medications (including valproic acid) during pregnancy tend to score lower on "cognitive function" tests (which are used to test intelligence, abstract reasoning, and problem solving), compared to children whose mothers took other epilepsy medications while pregnant.
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.