Ketorolac / phenylephrine ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Omidria

Ketorolac / phenylephrine ophthalmic Pregnancy Warnings

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

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.

Comments:
-Premature closure of the fetal ductus arteriosus has occurred with third trimester use of oral and injectable nonsteroidal anti-inflammatory drugs (NSAIDs); ketorolac plasma concentrations are detectable following ocular administration of this combination drug.
-Use of this drug during late pregnancy should be avoided.

Animal reproduction studies have not been conducted with this drug or phenylephrine. Oral administration of ketorolac during late gestation produced dystocia and increased pup mortality at higher doses. 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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Ketorolac / phenylephrine ophthalmic Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-Systemic exposure to this drug is low following a lens replacement procedure.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.

See references