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September 18, 2013
Moderate Topical Corticosteroid Use Doesn’t Adversely
Affect Fetuses Taoyuan, Taiwan—Here’s some comforting news pharmacists can share with pregnant women who ask about using topical corticosteroids to treat skin conditions. A new study, published recently in JAMA Dermatology, “showed no associations of maternal topical corticosteroid exposure with orofacial cleft, preterm delivery, fetal death, low Apgar score, and mode of delivery. With this study and all available evidence taken together, the risk of low birth weight seems to correlate with the quantity of topical corticosteroid exposure,” according to the authors from Chang Gung University College of Medicine in Taiwan. Researchers caution, however, that while the primary analysis showed no associations between topical corticosteroid exposure and maternal outcomes, an exploratory analysis showed an increased risk of low birth weight when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 grams during the entire pregnancy. The report’s background notes that topical corticosteroids are the most frequently used drugs for treating skin conditions and are prescribed to more than 6% of pregnant women. It further points out that the FDA labels topical corticosteroids as pregnancy risk category C, indicating that animal studies have shown adverse fetal effects, and states that the medications should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Recognizing the dearth of adequate and well-controlled studies of use of the therapy in pregnant women, the researchers set out to determine whether maternal exposure to topical corticosteroids has adverse effects on fetal development. For the study, 2,658 pregnant women exposed to topical corticosteroids were compared to 7,246 pregnant women who were not exposed. Researchers found no associations of maternal topical corticosteroid exposure with orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery in the primary analysis (adjusted risk ratio [RR], 1.85 [95% CI, 0.22-15.20] [P = .57]; 0.97 [95% CI, 0.78-1.19] [P = .75]; 1.20 [95% CI, 0.73-1.96] [P = .48]; 1.07 [95% CI, 0.56-2.05] [P = .84]; 0.84 [95% CI, 0.54-1.31] [P = .45]; and P = .76, respectively). Stratified analyses based on potency also uncovered no significant associations in most of those categories, but an exploratory analysis showed “a significantly increased risk of low birth weight when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy (adjusted RR, 7.74 [95% CI, 1.49-40.11]; P = .02),” according to the results. “The absolute risk for [low birth weight] from limited use of strong topical corticosteroids is small, but the risk increases with heavy maternal use of strong topical corticosteroids,” the authors write. “Therefore, for pregnant women with a skin condition, mild or moderate topical corticosteroids are the preferred treatments if indicated. When potent or very potent topical corticosteroids are needed, the amounts used should be kept to a minimum, and fetal growth should be monitored.” |
U.S. Pharmacist Social Connect
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