Frova and Pregnancy

The FDA has classified Frova as a pregnancy Category C medication, meaning that the medication may not be safe to take while pregnant because it does appear to cause harm to the fetus in animal studies. When Frova was given to pregnant rats, there was an increase in the number of embryo deaths, there were problems with the urinary tracts of the baby rats, and the medication caused bone changes in the baby rats. Therefore, be sure to talk to your healthcare provider about the risks and benefits of Frova and pregnancy.

 

An Overview of Frova and Pregnancy

For women who are pregnant, Frova® (frovatriptan succinate) may not be safe. This is based on animal studies that looked at the effects of Frova during pregnancy.
 

Frova 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.
 
Frova was given a pregnancy Category C rating based on studies that were done on pregnant animals. For example, when Frova was given to pregnant rats, there were problems with the urinary tracts of the baby rats. Also, Frova caused bone changes in the baby rats and increased the chance of embryo death.
 
It is important to note, however, 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 the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
(Frova 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;