Studies in rats showed no embryofetal toxicity or malformations during organogenesis at doses about 10 times the maximum human exposure. Abortions occurred in rabbits in the presence of maternal toxicity (reduced bodyweight gain with reduced food consumption) but there were no malformations at 15 mg/kg/day following administration of this drug during organogenesis. Ocular abnormalities including cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration and hemorrhage were observed in the offspring of rats administered this drug from Gestation Day 6 through Lactation Day 20 at 7.5 mg/kg day (about 3.5 times the recommended human dose based on AUC comparisons).

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 contraindicated in females of reproductive potential and in pregnant women.

US FDA pregnancy category: Not assigned

Risk summary: This drug may cause fetal harm when administered to a pregnant woman.

Comments:
-There are limited human data in pregnant women exposed to this drug during clinical trials, and it is insufficient to exclude a potential risk of cataracts and other eye abnormalities in human infants. Moreover, the prolonged drug exposure window precludes mitigation of the embryo-fetal toxicity risks.

See references

Use is contraindicated.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-There were no reported adverse effects in breastfed infants following maternal exposure to this drug during lactation; however, given the limited duration of follow-up during the post-natal period, and the findings from animal data, no conclusions can be drawn.

-Animal studies reported ocular abnormalities in the offspring of rats administered this drug from gestation to lactation at doses approximately 3.5 times the recommended human dose, however the relationship of this findings to breastfed infants is unknown.

See references