Is ceftriaxone safe to use during pregnancy?

From the Guidelines

Ceftriaxone should be used with caution during pregnancy due to insufficient information regarding its safety and efficacy in this population. The use of ceftriaxone in pregnancy is not routinely recommended due to limited data on its effects on the fetus 1. While it is a third-generation cephalosporin antibiotic effective against various bacterial infections, its safety profile during pregnancy is not well established.

Key Considerations

• The CDC guidelines recommend against the routine use of ceftriaxone in pregnancy due to insufficient information 1.
• Animal studies and limited human data have not shown significant risks, but more research is needed to confirm its safety.
• Ceftriaxone is classified as a category B medication by the FDA, indicating that animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women.

Clinical Use

• Ceftriaxone may be considered for use in pregnancy when the benefits outweigh the potential risks, such as in the treatment of serious bacterial infections.
• The typical adult dose is 1-2 grams given once or twice daily, usually intravenously or intramuscularly, with duration depending on the specific infection being treated.
• No dosage adjustment is typically needed during pregnancy, but close monitoring of the patient is recommended.

Safety and Efficacy

• The safety profile of ceftriaxone is related to its mechanism of action, which targets bacterial cell wall synthesis without significantly affecting human cells.
• However, the lack of sufficient data on its use in pregnancy means that it should only be used when clearly needed and prescribed by a healthcare provider familiar with the patient's complete medical history.

From the FDA Drug Label

Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed

Ceftriaxone safety in pregnancy:

• The drug label indicates that reproductive studies in animals have shown no evidence of embryotoxicity, fetotoxicity, or teratogenicity.
• However, there are no adequate and well-controlled studies in pregnant women.
• The label advises that ceftriaxone should be used during pregnancy only if clearly needed 2, 3.
• Key points:
  • No evidence of harm in animal studies
  • Limited human data
  • Use with caution if clearly needed
• Clinical decision: Ceftriaxone can be used in pregnancy if clearly needed, but with caution and careful consideration of the potential risks and benefits.

From the Research

Safety of Ceftriaxone in Pregnancy

• Ceftriaxone has been studied for its efficacy and safety in pregnant women, with results indicating its effectiveness in treating various infections during the perinatal period 4.
• A study published in 1988 found that ceftriaxone was effective in 75% of cases, with no adverse reactions observed subjectively or objectively, and no abnormal signs in neonates 4.
• Another study published in 2020 found that ceftriaxone had low resistance rates among common uropathogens, making it a suitable option for treating urinary tract infections in pregnant women 5.

Pharmacokinetics and Protein Binding

• A study published in 1993 found that the pharmacokinetics and protein binding of ceftriaxone during pregnancy were similar to those in healthy subjects, with no accumulation of the drug and excellent tolerance 6.
• Another study published in 1993 found that ceftriaxone had a low transplacental passage, with fetal concentrations being lower than maternal concentrations 7.

Clinical Applications

• Ceftriaxone has been evaluated as a treatment agent for primary and secondary syphilis in pregnancy, with results indicating its efficacy in reducing serum RPR titers and preventing congenital syphilis 8.
• The drug has also been used to treat other infections during pregnancy, including chorioamnionitis and pyelonephritis, with good outcomes and no reported adverse effects 4, 6, 7.