Firazyr and Pregnancy

When given to pregnant animals, Firazyr (icatibant) caused a number of problems, such as miscarriages and premature delivery. However, this drug has not been adequately studied in pregnant women, so the potential risks are currently unknown. As a pregnancy Category C medicine, it should only be given to a pregnant woman when the benefits outweigh the risks.

Can Pregnant Women Use Firazyr?

Firazyr^® (icatibant) is a prescription medicine approved to treat acute attacks of swelling in people with a rare condition called hereditary angioedema (HAE). It may not be safe for use during pregnancy, although the full risks are currently unknown.

What Is Pregnancy Category C?

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. Firazyr is classified as a pregnancy Category C medication.

Pregnancy Category C is given to medicines that have not been studied in pregnant women 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.

Firazyr has not been adequately studied in pregnant women. In animal studies, Firazyr did not cause birth defects when given to pregnant rats or rabbits. However, it did cause other problems, including delayed childbirth and miscarriages in pregnant rats, and premature delivery and miscarriages in 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, including Firazyr, may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Because HAE attacks can be potentially life-threatening, a healthcare provider may recommend this medicine for pregnant women.

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