Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned

Comments: Based on animal data, this drug may cause fetal harm.

Animal studies have revealed evidence of adverse developmental effects (increased mortality, decreased growth, delayed sexual development, altered behavior) at clinically relevant doses; most of these effects occurred at doses that were also associated with maternal toxicity. Although IV administration of this drug (3, 20, or 200 mg/kg) prior to and throughout mating in male and female animals and continuing in females to gestation day 7 had no effect on fertility, disruption of the estrus cycle and mating behavior were observed at the highest dose tested. No effects on reproductive function were observed at the lower doses, which are up to 3 times the recommended human dose on a body surface area basis. 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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In animals administered this drug from gestation day 17 throughout lactation, adverse effects were observed including maternal toxicity, increased stillbirths, and delayed physical development (vaginal opening) and mortality in offspring.

Safety has not been established; benefit should outweigh risk.

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

Comments: The effects in the nursing infant and on milk production are unknown.

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