Depakote and Pregnancy
In clinical studies on Depakote and pregnancy, the medication was shown to cause birth defects in humans. However, since uncontrolled epilepsy can also be dangerous to both a pregnant woman and the fetus, a healthcare provider can still prescribe Depakote to a pregnant woman if he or she believes that the benefits outweigh the possible risks. If you are taking Depakote and pregnancy occurs (or you are thinking of becoming pregnant), let your healthcare provider know.
Depakote® (divalproex sodium) may not be safe for women who are pregnant, depending on the condition being treated and the severity of the condition. In previous studies that looked at the effects of Depakote during pregnancy, the drug caused birth defects and other problems.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Depakote is in pregnancy Category D when used for the treatment of epilepsy or manic episodes associated with bipolar disorder.
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 may still offer benefits that outweigh the risks that the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Depakote is in pregnancy Category X when used for the prevention of migraine headaches. 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 Depakote for this reason and become pregnant or plan on becoming pregnant should contact their healthcare provider before stopping the medication, as it should not be stopped abruptly.
Many studies have shown that Depakote may cause birth defects in humans. Sometimes, these birth defects can be very severe.
Studies have also shown that children born to women who took valproate medications (including Depakote) 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.
Pregnant women should not take Depakote unless absolutely necessary. However, uncontrolled epilepsy can also be dangerous to both a pregnant woman and the fetus. You and your healthcare provider must discuss the specific benefits and risks of using Depakote during pregnancy for your particular situation. If your epilepsy is very mild (or if you have not had a seizure in several years), you may consider stopping Depakote. However, if your epilepsy is severe or difficult to control, it may be best for you to stay on Depakote. No matter what, do not stop taking Depakote suddenly (see Depakote Withdrawal).
If you and your healthcare provider decide that it is best for you to continue taking Depakote during pregnancy, you will need frequent blood tests to measure your Depakote 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.