In animal studies, this drug increased the incidences of skeletal variations in rat pups (wavy ribs and incompletely ossified ribs) at a dose estimated to be 711 times the maximum recommended human dose (MRHD). In rabbits, maternal toxicity described as decreased maternal weight gain occurred in all dose groups. 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.

Safety has not been established during pregnancy

US FDA pregnancy category: Not assigned

Risk summary: Data in human pregnancy are insufficient to assess for a drug associated risk for major birth defects or miscarriage; animal studies have not shown embryofetal lethality or fetal malformations.

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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 effects 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.

Studies have shown this drug is transferred into the milk of lactating rats with a concentration ratio for milk to plasma of 0.04 to 0.05 across doses. There were no measurable drug levels in the plasma of nursing pups.

See references