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Ketorolac Pregnancy and Breastfeeding Warnings

Ketorolac is also known as: Sprix, Toradol, Toradol IM, Toradol IV/IM

Medically reviewed on November 20, 2017.

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. Data from epidemiological studies suggest an increased risk of miscarriage after use of a prostaglandin synthesis inhibitor in early 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 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.

Avoid use during pregnancy, especially after 30 weeks gestation
Contraindicated during labor and delivery

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

Comments:
-Use of NSAIDs during the third trimester of pregnancy increase the risk of premature closure of the fetal ductus arteriosus and should therefore be avoided.

See references

Ketorolac Breastfeeding Warnings

Limited data suggests breast milk levels of ketorolac are low with usual oral doses, however, milk levels have not been measured after higher injectable doses. Following 1 day of dosing 10 mg orally every 6 hours, the maximum milk concentration was 7.9 ng/mL and the maximum milk to plasma ratio was 0.025. Using these numbers, this calculates to a 0.4% maternal weight-adjusted dose.

Benefit should outweigh risk

Excreted into human milk: Yes

Comments: Available evidence has not shown specific adverse effects in nursing infants; some authorities deem this product contraindicated for the treatment of nursing mothers.

See references

References for pregnancy information

  1. "Product Information. Sprix (ketorolac)." American Regent Laboratories Inc, Shirley, NY.
  2. "Product Information. Ketorolac Tromethamine (ketorolac)." Hospira Inc, Lake Forest, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Toradol (ketorolac)." Roche Laboratories, Nutley, NJ.

References for breastfeeding information

  1. "Product Information. Toradol (ketorolac)." Roche Laboratories, Nutley, NJ.
  2. "Product Information. Sprix (ketorolac)." American Regent Laboratories Inc, Shirley, NY.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Ketorolac Tromethamine (ketorolac)." Hospira Inc, Lake Forest, IL.
  6. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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