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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Oral and injectable systemic corticosterois are steroid hormones prescribed to decrease inflammation in diseases and conditions such as arthritis (rheumatoid arthritis, for example), ulcerative colitis, Crohn's disease, asthma, bronchitis, some skin rashes, and allergic or inflammatory conditions that involve the nose and eyes. Examples of systemic corticosteroids include hydrocortisone (Cortef), cortisone, prednisone (Prednisone Intensol), prednisolone (Orapred, Prelone), and methylprednisolone (Medrol, Depo-Medrol, Solu-Medrol). Some of the side effects of systemic corticosteroids are swelling of the legs, hypertension, headache, easy bruising, facial hair growth, diabetes, cataracts, and puffiness of the face.