Desoximetasone

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of desoximetasone cream USP 0.25% and 15 to 150 times the human dose of desoximetasone cream USP 0.05%, or desoximetasone gel USP 0.05%.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, desoximetasone cream USP 0.05%, desoximetasone cream USP 0.25%, or desoximetasone gel USP 0.05%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Desoximetasone was nonmutagenic in the Ames test.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

In controlled clinical studies the incidence of adverse reactions were low (0.8%) for desoximetasone cream USP 0.25%, and included burning, folliculitis, and folliculo-pustular lesions. The incidence of adverse reactions were also 0.8% for desoximetasone cream USP 0.05% and included pruritus, erythema, vesiculation, and burning sensation. The incidence of adverse reactions for desoximetasone gel USP, 0.05% was 0.3% with one subject reporting stinging and burning at the site of application.