Halovate Use In Pregnancy & Lactation

Pregnancy: 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.
Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Halobetasol propionate. Halobetasol propionate was embryotoxic in rabbits but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
There are no adequate and well-controlled studies of the teratogenic potential of Halobetasol propionate in pregnant women. Halobetasol propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Formulations containing potent steroids like Halobetasol should not be used extensively, in large amounts, or for protracted periods in pregnant patients or in patients who are planning to become pregnant.
Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Halobetasol propionate is administered to a nursing woman.