C1 Esterase Inhibitor and Pregnancy
Is it safe for pregnant women to use C1 esterase inhibitor? Although this drug has not been adequately studied in pregnant women or animals, there may be times where the potential benefits of using the drug outweigh the unknown risks. Let your healthcare provider know if you are pregnant or thinking of becoming pregnant during treatment with this medication.
C1 esterase inhibitor (Berinert®, Cinryze®) is a prescription medicine used to prevent or treat swelling and sometimes painful attacks associated with hereditary angioedema (HAE). It may not be safe for use during pregnancy, although the full risks are not entirely known.
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. C1 esterase inhibitor is classified as a pregnancy Category C medication.
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.
C1 esterase inhibitor medicines have not been adequately studied in pregnant animals or women. However, there have been reports describing the use of the C1 esterase inhibitor in pregnant women. In these reports, C1 esterase inhibitor did not appear to increase the risk for birth defects or other problems in the unborn babies. However, all possible risks cannot be ruled out until the medication has been more thoroughly studied in pregnant women.
The manufacturers of C1 esterase inhibitor products recommend the drug only be given to pregnant women if clearly needed. Because HAE attacks can be potentially life-threatening, a healthcare provider may recommend treatment during pregnancy, despite the unknown risks.