Trileptal and Pregnancy

In animal studies that looked at Trileptal and pregnancy, the drug caused problems such as miscarriages, birth defects, and growth problems. However, it is important to keep in mind that animals do not always respond to drugs in the same way that humans do. Trileptal may still be prescribed to a pregnant woman if her healthcare provider believes that the benefits outweigh the possible risks to her unborn child.

Is Trileptal Safe During Pregnancy?

Trileptal® (oxcarbazepine) may not be safe for women who are pregnant. In previous animal studies involving Trileptal and pregnancy, the drug caused miscarriages, birth defects, and growth problems.
 

Trileptal and Pregnancy Category C

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 C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to pregnant rats, Trileptal increased the risk of birth defects, including facial, skull, heart, and skeletal defects. Trileptal also increased the risk of miscarriages and low birth weight.
 
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn child.
 

Final Thoughts on Trileptal and Pregnancy

If you are pregnant or thinking of becoming pregnant while taking Trileptal, let your healthcare provider know. He or she will consider the benefits and risks of using the medication during pregnancy before making a recommendation for your particular situation.
 
(Click Epilepsy and Pregnancy for more information about pregnant women with epilepsy.)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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