Teratogenicity including increased incidence of cleft palate have occurred in animal studies. A number of cohort and case controlled studies in humans suggest maternal corticosteroid use in the first trimester produces a slight increased risk of cleft lip with or without cleft palate (increased from 1 out of 1000 to 3 to 5 out of 1000 infants). Reduced placental and birth weight have been recorded in animals and humans after long term treatment. There is the possibility of adrenal cortex suppression in the newborn with long term use in the mother; however the short term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant. Cataracts have been observed rarely in infants born to mothers receiving long-term corticosteroid therapy during pregnancy. Maternal pulmonary edema has been reported with inhibition of uterine contractions and fluid overload. There are no adequate and well controlled studies in pregnant women.

Disturbances of spermatogenesis have been observed with use of this drug at high doses for an extended period of time (30 mg/day for a minimum of 4 weeks); disturbances persisted for several months after discontinuation but eventually resolved.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should only be used during pregnancy if the benefit outweighs the potential risk to the fetus

AU TGA pregnancy category: A
US FDA pregnancy category: C/D

Comments:
-Observe for signs and symptoms of hypoadrenalism in infants exposed to this drug in utero.
-Women who become pregnant while using this drug should be apprised of the potential fetal risks.
-The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or newborn infant.

See references

Drug concentrations in human milk are expected to be 5% to 25% of the maternal serum levels. Total infant doses are expected to be about 0.14% of the maternal daily dose. High doses for long periods of time could produce infant growth and development problems, interfere with infant endogenous corticosteroid production, and occasionally cause temporary loss of milk supply.

Use caution; this drug should be used only if clearly needed

Excreted into human milk: Yes

Comments:
-If this drug is necessary, the lowest dose should be prescribed; avoiding breastfeeding for 4 hours after a dose should minimize exposure to the infant.
-If maternal doses exceed 40 mg per day, the infant should be monitored for adrenal suppression.

See references