Oral administration of calcipotriene to pregnant animals during organogenesis caused in an increase in minor skeletal abnormalities, including enlarged fontanelles and extra ribs. Subcutaneous administration of betamethasone dipropionate to pregnant animals during organogenesis caused fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: Gel/ointment formulations: B1; foam formulation: B3
US FDA pregnancy category: Not assigned.

Risk Summary: Studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids.

Comments:
-Advise pregnant women that that this topical drug combination may increase the potential risk of having a low birth weight infant and to use it on the smallest area of skin and for the shortest duration possible.

See references

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-It is not known whether topically administered calcipotriene or corticosteroids could result in enough systemic absorption to produce detectable quantities in human milk.
-Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
-Do not apply this topical combination drug on the breast area while nursing.

-Use of betamethasone 3 to 9 days prior to delivery of a preterm infant might decrease postpartum milk production in some women.
-Because it is poorly absorbed after topical application, calcipotriene is probably a low risk to the nursing infant and is generally considered acceptable during breastfeeding, even to the nipple area.
-Avoid application of this topical drug combination containing betamethasone to the breast. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.

See references