Parsabiv Pregnancy Warnings
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: There are no available data in pregnant women; in animal studies, there was reduced fetal growth associated with maternal toxicities of hypocalcemia, tremoring, and reductions in body weight and food consumption.
Administration of this drug at 1.8 times the human exposure to pregnant rats during organogenesis through delivery and weaning revealed a slight increase in perinatal pup mortality, delay in parturition, and transient effects on pup growth. No effect on sexual maturation, neurobehavioral, or reproductive function were seen in the rat offspring. In embryofetal studies in rats and rabbits administered 2.7 and 7 times, respectively, the estimated human dose during organogenesis revealed reduced fetal growth. There are no controlled data in human pregnancy.
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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