Topamax and Pregnancy

In studies on Topamax and pregnancy, the medication caused birth defects, miscarriages, and low fetal weight when it was given to pregnant animals. When the drug was given to pregnant humans, it also caused some birth defects (although it was taken with other seizure medications). If you are taking Topamax and pregnancy occurs, talk to your healthcare provider so he or she can weigh both the benefits and risks before making a recommendation for your situation.

 

Topamax and Pregnancy: An Overview

For people who are pregnant, Topamax® (topiramate) may not be safe. This is based on animal studies that looked at the effects of Topamax during pregnancy.
 

Topamax 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.
 
Topamax was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, rats, or mice, Topamax caused birth defects, miscarriages, and decreased fetal weight. In small studies of Topamax in pregnant women, a few birth defects were seen, especially hypospadias (a birth defect in boys in which the opening to the urinary tract is not located at the tip of the penis). It is important to understand that in these studies, Topamax was taken with other seizure medications (which may have caused the birth defects).
 
However, it is important to note that seizures in a pregnant woman can also be damaging to the unborn child. Therefore, a pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. It is recommended that women taking Topamax receive folic acid supplementation, starting before conception (as is recommended for all epilepsy medications). If possible, Topamax should be avoided during the first trimester of pregnancy (unless it is necessary to control seizures).
 
(Topamax 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;