Is ceftriaxone (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. According to the guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, no alternatives to penicillin have been proven effective and safe for treatment of syphilis during pregnancy or for prevention of fetal infection 1. The use of ceftriaxone during pregnancy is not recommended due to lack of data, and it is classified as a Category B medication by the FDA, meaning animal studies have not shown risk to the fetus, but there are no adequate well-controlled studies in pregnant women showing adverse effects.

Some key points to consider when using ceftriaxone during pregnancy include:

• The standard adult dosing of ceftriaxone is typically 1-2 grams given once or twice daily, depending on the type and severity of infection being treated.
• Ceftriaxone is a third-generation cephalosporin antibiotic that crosses the placenta but has not been associated with birth defects or other adverse pregnancy outcomes when used appropriately.
• The benefits of using ceftriaxone usually outweigh the potential risks, especially for serious infections that could harm both mother and fetus if left untreated.
• As with any medication during pregnancy, ceftriaxone should only be used when clearly needed, and the lowest effective dose should be administered for the shortest duration necessary to treat the infection adequately, as stated in the guidelines for treating opportunistic infections among HIV-infected adults and adolescents 1.

Healthcare providers should always be informed about pregnancy status before prescribing ceftriaxone or any medication. It is essential to weigh the potential benefits and risks of using ceftriaxone during pregnancy and to consider alternative treatments when possible.

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 use in pregnancy should be approached with caution.

• The drug is classified as Pregnancy Category B, indicating that reproductive studies in animals have shown no evidence of harm to the fetus.
• However, there are no adequate and well-controlled studies in pregnant women, which means that the safety of ceftriaxone in human pregnancy has not been fully established.
• Ceftriaxone should only be used during pregnancy if clearly needed, as the potential benefits must outweigh the potential risks to the fetus 2, 3.
• It is essential to carefully weigh the risks and benefits and consider alternative treatments if possible.

From the Research

Ceftriaxone Use in Pregnancy

• Ceftriaxone has been studied as a treatment agent for primary and secondary syphilis in pregnancy, with results indicating its potential as an alternative treatment option 4.
• The pharmacokinetics and protein binding of ceftriaxone during pregnancy have been evaluated, showing no significant differences in pharmacokinetic parameters between pregnant women and healthy subjects, and no accumulation of the drug during treatment 5.
• Ceftriaxone has been used to treat various infections during the perinatal period, with an efficacy rate of 75% and no reported adverse reactions in one study 6.
• The clinical pharmacokinetics of ceftriaxone during the third trimester of pregnancy have been studied, with findings indicating that the usual recommended dosage is adequate and that there is no evidence of accumulation of the drug 7.

Safety and Efficacy

• Ceftriaxone has been found to be safe and effective in treating serious infections, including skin and soft tissue infections, in both adults and children 8.
• The drug's long serum half-life allows for once-daily or every 12-hour dosing, making it a convenient option for patients 8.
• However, it is essential to note that while ceftriaxone appears to be safe and effective, more extensive data is needed to fully substantiate its efficacy and safety in various patient populations, including pregnant women 8.

Key Findings

• Ceftriaxone may be considered an alternative treatment option for early syphilis in pregnancy 4.
• The pharmacokinetics of ceftriaxone are similar in pregnant women and healthy subjects, with no accumulation of the drug during treatment 5, 7.
• Ceftriaxone has been used effectively to treat various infections during the perinatal period, with no reported adverse reactions in some studies 6.