Carbamazepine and Pregnancy

In previous studies that looked at carbamazepine and pregnancy, carbamazepine raised the risk of birth defects, such as head and facial deformities, spina bifida, and heart defects. Therefore, the FDA has classified carbamazepine as a pregnancy Category D drug, which means that it may not be safe for use during pregnancy. However, if the benefits to the pregnant woman outweigh possible the risks to the child, a healthcare provider may still prescribe carbamazepine.

 

Is Carbamazepine Safe During Pregnancy?

Carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) may not be safe for women who are pregnant. In animal and human studies involving carbamazepine and pregnancy, the drug caused problems in the fetus, including birth defects.
 

Carbamazepine 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.
 
Studies involving women suggest that carbamazepine use during pregnancy increases the risk of birth defects, including head or facial deformities, spina bifida, and heart defects. Animal studies also show these risks. There have also been reports of seizures, breathing problems, vomiting, and diarrhea in newborns whose mothers were taking carbamazepine during pregnancy. It is important to understand that most of the women in these studies were taking carbamazepine for epilepsy, not for other conditions.
 
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 carbamazepine 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 carbamazepine. However, if your epilepsy is severe or difficult to control, it may be best for you to stay on carbamazepine. No matter what, do not suddenly stop taking carbamazepine (see Carbamazepine Withdrawal).
 
While carbamazepine may be necessary for some pregnant women with epilepsy, it is usually not essential for pregnant women with bipolar disorder, trigeminal neuralgia, or other conditions. Other medications are available that may be less dangerous for the fetus.
 
If you and your healthcare provider decide that it is best for you to continue taking carbamazepine, you may need frequent blood tests to measure your carbamazepine levels. Pregnancy can affect the way your body handles carbamazepine, and it is important to keep your dose at the lowest effective level (to help protect your fetus). Also, it is best if you can take just one seizure medication (rather than multiple seizure medications). Your healthcare provider may suggest a higher-than-usual dose of folic acid, as this may also help protect the fetus.
 
(Carbamazepine and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;