Tavneos Pregnancy Warnings
Benefit should outweigh risk.
US FDA pregnancy category: Not assigned
Risk summary: No data is available on the use of this drug in pregnant women to inform a drug-related risk. In animal reproduction studies, administration to hamsters and rabbits during organogenesis caused no evidence of fetal harm at exposure up to approximately 5 and 0.6 times, respectively the maximum recommended human dose (MRHD).
In animal reproduction studies, administration to hamsters and rabbits during organogenesis caused no evidence of fetal harm at exposure up to approximately 5 and 0.6 times, respectively, the maximum recommended human dose (MRHD). An embryo-fetal development study with pregnant hamsters revealed incidence of a skeletal variation, described as supernumerary ribs, at exposures approximately 5 times the equivalent human exposure. Another animal embryo-fetal development study during the period of organogenesis from gestation days 6 to 18, demonstrated an increase in the number of abortions at an exposure 0.6 times the MRHD; however, no evidence of fetal harm was observed with such exposures. In a study during prenatal and postnatal development in pregnant animals, the drug had no effect on the growth and development of the offspring at doses up to approximately 5 times the MRHD. 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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Tavneos Breastfeeding Warnings
This drug has not been measured in the milk of lactating animals. However, in a pre-and post-natal development study with hamsters at a pup to maternal plasma ratio of 0.37, drug was detected in the plasma of nursing offspring, suggesting milk secretion of the drug.
Benefit should outweigh risk.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-There are no data on the effects of this drug on the breastfed infant or its impact on milk production.
-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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