Ketorolac ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Acular, Acular LS, Acular PF, Acuvail

Medically reviewed by Drugs.com. Last updated on Jul 10, 2024.

Ketorolac ophthalmic Pregnancy Warnings

Avoid use during third trimester of pregnancy.
Prior to third trimester: Use only if the potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C (0.45% and 0.5% ophthalmic solutions); Not assigned (0.4% ophthalmic solution)

Risk summary (0.4% ophthalmic solution): No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of dystocia and increased pup mortality at oral doses of 1.5 mg/kg/day (about 40 times the typical human ophthalmic daily dose). Prostaglandin inhibitors used during late pregnancy have demonstrated adverse effects on the fetal cardiovascular system, including closure of the fetal ductus arteriosus. There are no controlled data in human pregnancy.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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.

See references

Ketorolac ophthalmic Breastfeeding Warnings

Caution is recommended; according to some experts, use is not recommended.

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

Comments:
-This drug is present in breast milk following oral administration.
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.

See references

Further information

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