This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk; however, systemic exposure from ocular administration is low.

Animal studies have failed to reveal evidence of teratogenicity. Oral doses up to 1000 mg/kg/day (Cmax in rat dams about 20 mcg/mL, about 46,500 times plasma levels in humans at recommended human ophthalmic dose [RHOD]) were associated with maternal toxicity (reduced weight gain and food intake) and maternal mortality but not with visceral or skeletal malformations in rat fetuses; increased postimplantation loss and decreased fetal weight, fetal ossification, pup weight (compared to controls), and rate of neonate survival observed. The No Observed Adverse Effect Level for fetal/neonate and maternal toxicity was 100 mg/kg/day (Cmax 5 mcg/mL, about 11,600 times plasma levels in humans at RHOD). There are no controlled data in human pregnancy.

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.

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Systemic exposure after topical ocular administration is low; not known if drug levels are measurable in maternal milk after topical ocular administration. Although this drug has not been measured in human milk, excretion in human milk can be presumed.

Caution is recommended.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Maternal use of an ophthalmic drop containing this drug poses negligible risk for a nursing infant.
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute then removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches the breast milk after using eye drops.

See references