Is Stavzor Safe During Pregnancy?
Stavzor™ (
delayed release valproic acid) may not be safe for women who are pregnant, although sometimes the benefits may outweigh the possible risks. In studies that looked at the effects of Stavzor during pregnancy, the drug caused birth defects and other problems.
Stavzor and Pregnancy Category D
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. 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 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.
Numerous studies have demonstrated that Stavzor may cause birth defects in humans. These birth defects can be very severe, and pregnant women should not take Stavzor unless absolutely necessary. For instance, it is not a good idea to take Stavzor during pregnancy for
migraine prevention, since
migraines are not a life-threatening condition.
However, uncontrolled
epilepsy can be dangerous to both a pregnant woman and the fetus. Some pregnant women with epilepsy may need to stay on Stavzor during pregnancy
(see Epilepsy and Pregnancy for more information about pregnant women with epilepsy).
You and your healthcare provider must discuss the specific benefits and risks of using Stavzor during pregnancy in your particular situation. If your epilepsy is very mild (or if you have not had a
seizure in several years), you may consider stopping Stavzor. However, if your epilepsy is severe or difficult to control, it may be best for you to stay on Stavzor. No matter what, do not stop taking Stavzor suddenly.
If you and your healthcare provider decide that it is best for you to continue taking Stavzor, you will need frequent blood tests to measure your Stavzor levels. Pregnancy can affect the way your body handles Stavzor, 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.
