Calcitriol topical Pregnancy and Breastfeeding Warnings

Brand names: Vectical

Medically reviewed by Drugs.com. Last updated on Nov 21, 2023.

Calcitriol topical Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned

Comments:
-Available data on topical, oral, and intravenous exposure during pregnancy have not identified an increased risk of major birth defects, miscarriages, or adverse fetal or maternal effects.
-Calcium levels should be monitored.

Animal studies of oral administration up to 0.9 mg/kg/day did not show effects on fetal or reproductive parameters; topical administration (3 ppm) to 6.4% of the body surface area resulted in significantly elevated mean post-implantation loss and minor skeletal abnormalities from delayed ossification of the pubic bones, and a slightly increased skeletal variation (extra 13 th rib, reduced ossification of epiphyses) secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


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.

See references

Calcitriol topical Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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