From the FDA Drug Label
Pregnancy Teratogenic Effects. Pregnancy Category B Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose concentrations (i.e., 200 mg/kg/day). These doses, based on a mg/m2 basis, are estimated to be 4 and 2 times, respectively, the human daily dose of 500 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.
Pregnancy Teratogenic Effects 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. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed
Ceftriaxone and azithromycin are classified as Pregnancy Category B drugs.
- Key points:
- No evidence of harm to the fetus was found in animal studies for both ceftriaxone and azithromycin.
- There are no adequate and well-controlled studies in pregnant women for both drugs.
- Both drugs should be used during pregnancy only if clearly needed, as animal reproductive studies are not always predictive of human response 1 2.
- Clinical decision: Both ceftriaxone and azithromycin can be used during pregnancy if clearly needed, but with caution and careful monitoring, due to the lack of adequate and well-controlled studies in pregnant women.
From the Research
Safety of Ceftriaxone and Azithromycin During Pregnancy
- The safety of ceftriaxone and azithromycin during pregnancy is a concern due to potential risks to the fetus.
- According to 3, ceftriaxone is recommended for the treatment of gonorrhea in pregnant women, with a dose of 125 or 250 mg intramuscularly.
- Azithromycin is also commonly prescribed during pregnancy, particularly for the treatment of sexually transmitted diseases, toxoplasmosis, and malaria 4.
- However, studies have yielded conflicting results regarding the safety of azithromycin during pregnancy, with some reporting increased risks of spontaneous miscarriage, major congenital malformations, and preterm birth 4, 5, 6.
- A systematic review and meta-analysis found that prophylactic azithromycin during pregnancy reduced the risk of low birth weight and prematurity, but may increase the risk of stillbirth 6.
- Another study suggested that azithromycin exposure during pregnancy may affect fetal testicular development, particularly at high doses and during mid-pregnancy 5.
- The use of azithromycin during pregnancy should be carefully considered, weighing the potential benefits against the potential risks to the fetus 4, 7.
Key Findings
- Ceftriaxone is considered safe for use during pregnancy for the treatment of gonorrhea 3.
- Azithromycin may be associated with increased risks of adverse outcomes during pregnancy, but the evidence is conflicting 4, 5, 6.
- The use of azithromycin during pregnancy should be guided by clinical judgment and careful consideration of the potential risks and benefits 4, 7.