Berinert and Pregnancy
Although Berinert has not been adequately studied in pregnant animals or women, there have been some reports of women receiving this drug during pregnancy. Berinert did not appear to cause problems in the unborn children during any of these cases. However, the manufacturer of the drug recommends it only be given to a pregnant woman if it is clearly necessary.
Berinert® (C1 esterase inhibitor) is a prescription medicine used to treat painful swelling attacks that can occur in people with a condition known as hereditary angioedema (HAE). Berinert may not be safe for use during pregnancy.
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. Berinert 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.
Berinert has not been studied in pregnant animals, nor has it been systematically studied in pregnant women. There are reported cases of the drug being used in pregnant women. In these cases, Berinert did not appear to cause problems in the unborn babies or complications during labor and delivery. However, until the drug is adequately studied in pregnant women, all risks cannot be ruled out.
The manufacturer of Berinert recommends the medication only be given to a pregnant woman if clearly needed. Because hereditary angioedema attacks can be potentially life-threatening, a healthcare provider may recommend treatment with Berinert during pregnancy despite the unknown risks.