Desonide

Risk Summary

There are no available data on desonide foam use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of a desonide cream, 0.05% formulation during organogenesis caused malformations characteristic of corticosteroids in rats and in rabbits (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of desonide observed in animal studies to the systemic exposure that would be expected in humans after topical use of desonide foam.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Topical administration of a desonide cream, 0.05% formulation to pregnant rats (gestational days 6 to 15) and pregnant rabbits (gestational days 6 to 18) at 0.2, 0.6, and 2.0 g cream/kg/day was associated with maternal body weight loss at all dose levels in both species. Malformations characteristic of corticosteroids were observed in rats at topical doses of ≥0.6 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No malformations were observed at a topical dose of 0.2 g cream/kg/day in rats and at a topical dose of 0.6 g cream/kg/day in rabbits.

Risk Summary

There are no data on the presence of desonide in human or animal milk, its effects on the breastfed infant, or its effects on milk production.

It is not known whether topical administration of desonide foam could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for desonide foam and any potential adverse effects on the breastfed infant from desonide foam or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use desonide foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women to wash off any desonide foam that has been applied to the nipple and areola prior to breastfeeding to avoid direct infant exposure.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of desonide foam 0.05% or desonide.

In a 90-day repeat-dose toxicity study in rats, topical administration of desonide foam 0.05% at dose concentrations from 0.025% to 0.125% (providing 0.075 to 0.375 mg/kg/day of desonide) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Desonide revealed no evidence of mutagenic potential based on the results of 2 in vitro genotoxicity tests (Ames assay, mouse lymphoma cell assay) and an in vivo genotoxicity test (mouse micronucleus assay).

The effects of desonide on fertility have not been evaluated.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a controlled clinical trial of 581 subjects aged 3 months to 17 years, adverse reactions occurred at the application site in 6% of subjects treated with desonide foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse reactions for desonide foam and vehicle foam are noted in the following table.

Adverse Reactions in the Clinical Trial:

Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender.

The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post-approval use of desonide foam: application site irritation, application site erythema, skin reactions, and swelling face.

Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.