Is ceftriaxone (a cephalosporin antibiotic) safe to use during pregnancy?

From the Guidelines

Ceftriaxone is generally considered safe for use during pregnancy, as most studies have found that cephalosporin antibiotics, including ceftriaxone, are safe to use in pregnancy, with no fetal damage reported in animal studies and no increase in risk of congenital abnormalities or adverse pregnancy outcomes in humans 1.

Key Points to Consider

• Ceftriaxone is classified as FDA pregnancy category B, which means animal studies have not shown risk to the fetus, and there are no adequate well-controlled studies in pregnant women demonstrating adverse effects.
• The medication crosses the placenta but has not been associated with congenital abnormalities or adverse pregnancy outcomes when used appropriately.
• The standard adult dose of ceftriaxone is typically 1-2 grams given once or twice daily, depending on the severity and type of infection being treated.
• Ceftriaxone may be preferred over other antibiotics that have known teratogenic effects or limited safety data when treating infections during pregnancy.

Important Considerations

• As with any medication during pregnancy, ceftriaxone should be used only when clearly needed, and the benefits of treatment outweigh potential risks.
• Individual patient factors should always be considered, and treatment decisions should be made in consultation with healthcare providers familiar with the patient's specific situation.
• The safety profile of ceftriaxone is related to its mechanism of action, which targets bacterial cell wall synthesis without significantly affecting human cells.

Comparison with Other Antibiotics

• Other antibiotics, such as tetracyclines, aminoglycosides, and fluoroquinolones, may have more limited safety data or known teratogenic effects, making ceftriaxone a preferred option in some cases 1.
• However, the choice of antibiotic should always be based on the specific infection being treated and the patient's individual needs and 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 Pregnancy Teratogenic Effects Pregnancy Category B: 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.

Ceftriaxone Safety in Pregnancy:

• The FDA drug label indicates that ceftriaxone is classified as Pregnancy Category B, which means that reproductive studies in animals have not shown any evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women.
• Key Points:
  • No evidence of embryotoxicity, fetotoxicity, or teratogenicity in animal studies.
  • No adequate and well-controlled studies in pregnant women.
  • The drug should be used during pregnancy only if clearly needed.
• Clinical Decision: Ceftriaxone can be used during pregnancy if clearly needed, but with caution and careful monitoring, as there are no adequate and well-controlled studies in pregnant women 2 3.

From the Research

Ceftriaxone Safety in Pregnancy

• Ceftriaxone, a cephalosporin antibiotic, has been studied for its safety and efficacy in pregnant women 4, 5.
• A study published in 2005 found that ceftriaxone may be considered as an alternative for treatment of early syphilis in pregnancy, with 11 women showing decreased serum RPR titers and 10 developing negative RPR results after treatment 4.
• Another study published in 1993 evaluated the pharmacokinetics of ceftriaxone during the third trimester of pregnancy and found no evidence of accumulation, with mean kinetic parameter values similar to those found in healthy volunteers 5.
• The study also found that the usual recommended dosage of ceftriaxone (2 g/d) was adequate during the third trimester of pregnancy, with no premature deliveries or significant side effects reported 5.
• Additionally, a review published in 2006 stated that cephalosporins, including ceftriaxone, can be prescribed safely for penicillin-allergic patients, with no increased risk of allergic reaction 6.
• Ceftriaxone has also been shown to have a good tolerability profile, with common events including diarrhea, nausea, vomiting, candidiasis, and rash, but no significant increase in risk of allergic reactions in penicillin-allergic patients 7.

Pharmacokinetics and Efficacy

• Ceftriaxone has a long elimination half-life, allowing for once-daily administration, and has good activity against a range of bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria spp. 8, 7.
• The drug has been shown to be effective in treating various infections, including community-acquired and nosocomial infections, and has a well-characterized tolerability profile 7.
• Ceftriaxone may cause reversible biliary pseudolithiasis, but the incidence of true lithiasis is less than 0.1% 7.

Clinical Use

• Ceftriaxone can be used to treat a range of infections in pregnant women, including syphilis and other bacterial infections 4, 5.
• The drug should be used with caution in patients with a history of penicillin allergy, but the risk of cross-reactivity is low 6.
• Ceftriaxone has been shown to be effective and safe in pregnant women, with no significant increase in risk of allergic reactions or other adverse effects 4, 5, 6, 7.