Forteo Pregnancy Warnings
In pregnant mice administered 6 times the human dose based on body surface area (BSA), an increased incidence of skeletal deviations and variations were observed (interrupted rib, extra vertebra or rib). Developmental effects in a perinatal/postnatal study in pregnant rats receiving this drug from gestation Day 6 through postpartum Day 20 included mild growth retardation in female offspring at doses approximately 95 times the human dose based on BSA, and in male offspring at 420 times the human dose based on BSA. Additionally, there was reduced motor activity in both male and female offspring at this dose. There are no adequate and well-controlled studies in pregnant women.
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.
Use is not recommended
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: There are no available data in human pregnancy to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; in animal studies, this drug increased skeletal deviations and variations at 6 times the human dose.
Comments:
-If pregnancy is detected, this drug should be discontinued; according to some authorities, use is contraindicated during pregnancy.
-Women of childbearing potential should be encouraged to use effective contraceptive during therapy.
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