Primidone and Pregnancy

There have been reports of birth defects in women who took primidone during pregnancy. Because it is probably not safe to use primidone during pregnancy, the FDA has classified primidone as a pregnancy Category D medication. Be sure to talk to your healthcare provider about the risks and benefits of primidone and pregnancy he or she may still prescribe the medication if the benefits outweigh the possible risks to the unborn child.

 

Is Primidone Safe During Pregnancy?

Primidone (Mysoline®) is probably not safe for use during pregnancy. As with most epilepsy medications, primidone can cause problems during pregnancy.
 

Primidone 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.
 
There have been reports of birth defects possibly due to primidone, although it is difficult to know if primidone actually increases the risk of birth defects. It seems that women with epilepsy (even if they are not taking medication) have a higher risk of birth defects, compared to the general population.
 
If your healthcare provider decides that you should stay on primidone during pregnancy, there are a few steps that can be taken to increase your chances of a healthy pregnancy. Be sure you get enough folic acid. In fact, you may want to talk to your healthcare provider about taking a higher-than-usual dose of folic acid, as this may help protect against certain birth defects. Talk to your healthcare provider about finding the lowest possible primidone dose that is effective at controlling your seizures, as this may also decrease the risk of problems.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;