Corticosteroids, including EMFLAZA, readily cross the placenta. Adverse developmental outcomes, including orofacial clefts (cleft lip, with or without cleft palate ) and intrauterine growth restriction , and decreased birth weight, have been reported with maternal use of corticosteroids, including EMFLAZA, during pregnancy. Some epidemiologic studies report an increased risk of orofacial clefts from about 1 per 1000 infants to 3 to 5 per 1000 infants; however, a risk for orofacial clefts has not been observed in all studies. Intrauterine growth restriction and decreased birth weight appear to be dose-related; however, the underlying maternal condition may also contribute to these risks (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the . general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
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