Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Available data are insufficient to inform a drug associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes; there are disease associated risks to the mother and the fetus related to hypocalcemia in pregnancy.

Comments:
-Monitor infants born to mothers with hypocalcemia for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability (ranging from myotonic jerks to seizures), apnea, cyanosis, and cardiac rhythm disorders.

No adverse developmental effects were observed in pregnant rats and rabbits administered this drug from organogenesis through lactation at doses 123 times and 8 times, respectively, the estimated human exposure at 100 mcg/day (clinical dose). Pregnant rats receiving this drug prior to birth through weaning at dose 10 times the estimated human exposure showed an increased incidence of dehydration, broken palate, and palate injuries related to incisor misalignment; mortality was observed in offspring. In humans, maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures. There are no adequate and well-controlled studies in pregnant women.

There are no data on the effects of this drug on human fertility; animal data do not indicate impairment of fertility.

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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Mean parathyroid hormone concentrations in rat milk have been estimated to be 42 times lower than milk plasma concentrations; a dose of 1000 mcg/kg/day yielded a rat milk concentration of approximately 10 ng/mL. 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.

Benefit should outweigh risk

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

Comments:
-Monitor for signs and symptoms of hypercalcemia or hypocalcemia in infants exposed to parathyroid hormone through breast milk; consider monitoring serum calcium levels.

See references