Calcitonin injection Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Risk Summary: There are no data in pregnant women to inform a drug associated risk for birth defects or miscarriage; subcutaneous administration in rabbits has been shown to decrease fetal birth weights.
Subcutaneous administration of this drug to rabbits at 4 to 18 times the human dose of 54 International Units/m2 has been shown to decrease fetal birth weights. In rats, no embryo/fetal toxicities were observed with maternal subcutaneous doses up to 80 International Units/kg/day from gestation day 6 to 15. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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.
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Calcitonin injection Breastfeeding Warnings
There is limited data on use of this drug during breastfeeding. Calcitonin is a normal component of human milk and may play a role in development of enteric neurons in breastfed infants. It is a large peptide, so absorption may be unlikely because it is more likely to be destroyed in the infant's gastrointestinal tract. Calcitonin has been shown to inhibit lactation in rats. For women with osteoporosis, breastfeeding may be stopped to reduce calcium loss.
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
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