Zarontin and Pregnancy

The FDA has classified Zarontin as a pregnancy Category C medication, meaning it may not be safe for use during pregnancy. The FDA assigned this classification due to a lack of animal or human pregnancy studies involving the drug. However, there have been reports of birth defects in babies whose mothers took Zarontin during pregnancy. Therefore, be sure to talk to your healthcare provider about the benefits and risks of Zarontin and pregnancy.

 

Is Zarontin Safe During Pregnancy?

Zarontin® (ethosuximide) may not be safe for use during pregnancy, as very little research has been done to evaluate the safety of Zarontin in pregnant women.
 

Zarontin 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 medications that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies. Also, medications that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Zarontin was assigned a pregnancy Category C classification due to a lack of animal or human pregnancy studies. There have been a few reports of birth defects (including cleft palate and other defects) in babies whose mothers took Zarontin during pregnancy. However, it is impossible to know if these problems were due to Zarontin or other factors. Generally, Zarontin is considered to be one of the safer seizure medications for use during pregnancy. In fact, many healthcare providers consider it to be the best medication for treating absence seizures during pregnancy.
 

Zarontin and Pregnancy: Final Thoughts

If you are pregnant or thinking of becoming pregnant while taking Zarontin, 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.)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;