Fycompa and Pregnancy
It is unknown whether it is safe for women to take Fycompa (perampanel) during pregnancy. Animal studies on this medication showed that it increased the risk for miscarriages, abnormalities of the intestines, and low fetal weights. If you are pregnant or thinking of becoming pregnant, talk to your healthcare provider about whether this medication is right for you.
Fycompa™ (perampanel) is a prescription medication approved for use with other drugs to treat partial-onset seizures in people with epilepsy. Based on animal studies, this drug may harm an unborn child if taken during pregnancy, although the full risks are currently unknown.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Fycompa is classified as a pregnancy Category C medicine.
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.
Fycompa has not been studied in pregnant women. However, it has been studied in pregnant rats and rabbits.
In animal studies, when Fycompa was given to pregnant rats, it increased the risk for abnormalities of the intestines -- more specifically, the growth of pouches on the wall of the intestines. These problems occurred even at doses that were similar to the normally recommended human dose. In higher doses, Fycompa increased the risk for miscarriages in the rats and reduced the weight of the developing rats. The drug also increased the risk for miscarriages when given to pregnant rabbits.
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 the benefits to the woman outweigh any possible risks to her unborn child.
If you become pregnant during treatment, ask your healthcare provider about enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of using Fycompa and other anti-seizure medications when pregnant.
(Click Epilepsy and Pregnancy for more information on this topic.)