Ketorolac Pregnancy and Breastfeeding Warnings
Ketorolac Pregnancy Warnings
Administration of NSAIDs during the latter part of pregnancy may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labor and delivery. The use of drugs known to inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
AU and UK: Contraindicated during pregnancy, labor, and delivery US: Contraindicated during labor and delivery; avoid use at, or after 30 weeks gestation; prior to 30 weeks gestation, use only if potential benefit justifies the potential risk to the fetus AU TGA pregnancy category: C US FDA pregnancy category: C prior to 30 weeks gestation US FDA pregnancy category: D starting at 30 weeks gestation
Ketorolac Breastfeeding Warnings
A peri/postnatal study in rats showed reduction in postnatal growth and survival of the offspring when ketorolac trometamol was administered to lactating rats at oral dose levels greater than 4.8 mg/kg/day. In human breast milk, limited data suggests milk levels of ketorolac are low with usual oral doses, however, milk levels have not been measured after higher injectable doses. Available evidence has not shown any specific adverse events in nursing infants.
Use is contraindicated Excreted into human milk: Yes
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