Studies have not revealed malformative effects, but have shown a risk for intra uterine growth retardation when beta-blockers were administered orally. Delayed ossifications occurred in animal models, but it did not result in adverse effects on postnatal development. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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 recommended only if clearly needed and the benefit outweighs the risk.

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

Risk Summary: Malformative risk with use of ophthalmic formulations of this drug in pregnant women is unlikely.

Comments:
-Signs and symptoms of beta-blockade (e.g., bradycardia, hypotension, respiratory distress, and hypoglycemia) have been observed in the neonate when beta-blockers have been administered until delivery.
-If this drug is administered until delivery, the neonate should be monitored during the first days of life.

See references

Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Patients using this drug during lactation may decrease systemic absorption by placing pressure over the tear duct for at least 1 minute after administration, and removing excessive solution with absorbent tissue.
-This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.
-Some experts state that alternative agents (e.g., levobunolol, metipranolol) should be considered when nursing preterm or newborn infants.

See references