Equetro and Pregnancy

In animal and human studies involving Equetro and pregnancy, the drug increased the risk of birth defects, including head or facial deformities, spina bifida, and heart defects. As a result, the FDA has classified Equetro as a pregnancy Category D medication, meaning that it may not be safe to take during pregnancy. However, a healthcare provider may still recommend Equetro if the benefits to the pregnant woman outweigh the risks to the unborn child.

 

Is Equetro Safe During Pregnancy?

Equetro® (carbamazepine) is a medication used to treat bipolar disorder. It may not be safe for pregnant women. In studies (both animal and human) that looked at the effects of taking carbamazepine (the active ingredient of Equetro) during pregnancy, the medication increased the risk of birth defects and other problems.
 

Equetro and Pregnancy Category D

The U.S. Food and Drug Administration (FDA) uses pregnancy risk categories 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 bipolar disorder.
 
While carbamazepine may be necessary for some pregnant women with epilepsy, it is usually not essential for pregnant women with bipolar disorder. Other medications are available that may be less dangerous for the fetus. However, there may be instances in which the benefits of Equetro for pregnant women with bipolar disorder may be greater than the risks.
 
If you and your healthcare provider decide that it is best for you to continue taking Equetro, you may need frequent blood tests to measure your Equetro levels. Pregnancy can affect the way your body handles Equetro, 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.
 
(Equetro 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;