What are the risks of using Toradol (Ketorolac) in early pregnancy?

From the Guidelines

Toradol (ketorolac) is not recommended for use during early pregnancy due to its potential to increase the risk of miscarriage and cause birth defects. Pregnant women should avoid this medication, especially during the first trimester, as it belongs to the nonsteroidal anti-inflammatory drug (NSAID) class. In later pregnancy, NSAIDs like Toradol can cause premature closure of the ductus arteriosus in the fetus, potentially leading to pulmonary hypertension.

Key Considerations

• The mechanism of action of Toradol, which inhibits prostaglandin synthesis, can affect important developmental processes and potentially interfere with implantation and placental development in early pregnancy 1.
• For pain management during pregnancy, acetaminophen (Tylenol) is generally considered the safest first-line option, with a typical recommended dose of 650-1000 mg every 6 hours as needed, not exceeding 4000 mg per day.
• If pain cannot be managed with acetaminophen alone, consultation with an obstetrician is essential to discuss alternative pain management strategies that balance maternal comfort with fetal safety.

Alternative Pain Management Strategies

• Acetaminophen is the preferred first-line treatment for pain during pregnancy.
• Other options, such as neuraxial morphine or hydromorphone, may be considered in certain situations, but should be used under the guidance of an obstetrician or anesthesiologist 1.
• Ketorolac may be used in the postpartum period for pain management, but its use during pregnancy is not recommended due to the potential risks to the fetus 1.

From the FDA Drug Label

Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies have been performed during organogenesis using daily oral doses of ketorolac tromethamine at 3.6 mg/kg (0. 37 times the human AUC) in rabbits and at 10 mg/kg (1 times the human AUC) in rats. Results of these studies did not reveal evidence of teratogenicity to the fetus. However, animal reproduction studies are not always predictive of human response Nonteratogenic Effects Because of the known effects of non-steroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. There are no adequate and well-controlled studies of ketorolac tromethamine in pregnant women. Ketorolac tromethamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Ketorolac use in early pregnancy should be avoided due to the potential risks to the fetus. The FDA drug label indicates that ketorolac tromethamine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus 2. It is also important to note that animal reproduction studies are not always predictive of human response.

• Key points:
  • No adequate and well-controlled studies in pregnant women
  • Potential risk to the fetus due to effects on fetal cardiovascular system
  • Use during pregnancy only if potential benefit justifies potential risk to the fetus
  • Pregnancy Category C 2

From the Research

Toradol Use in Early Pregnancy

• Toradol, also known as ketorolac, is a nonsteroidal anti-inflammatory drug (NSAID) that possesses significant analgesic potency 3.
• The use of NSAIDs, including ketorolac, during pregnancy is a concern due to the potential risks to the fetus, particularly in the third trimester 4.
• According to a study on medication use and pain management in pregnancy, NSAIDs should be avoided in the third trimester due to established risks, but may be appropriate for mild to moderate pain in the first and second trimesters 4.
• However, there is limited information available on the safety of ketorolac specifically during pregnancy, and most studies on NSAIDs do not provide detailed information on individual medications 5.
• A review of medication use in the first trimester of pregnancy found that ibuprofen and naproxen were among the most commonly used over-the-counter NSAIDs, but ketorolac was not specifically mentioned 5.
• The US Food and Drug Administration is committed to protecting and advancing the public health of pregnant women by guiding the development and ensuring the availability of effective and safe therapeutics for obstetrical indications and for medical conditions during pregnancy, but more research is needed to address the critical gaps in understanding fetal risk 6.