Cefuroxime Safety in Pregnancy
Cefuroxime is safe and compatible for use throughout pregnancy, with human data confirming it is not teratogenic at usual therapeutic doses. 1
Safety Profile
Cefuroxime is classified as FDA Pregnancy Category B1 [B], indicating compatibility during pregnancy. 1 The European Respiratory Society/Thoracic Society of Australia and New Zealand guidelines explicitly state that human data demonstrate cefuroxime and other cephalosporins are not teratogenic at usual therapeutic doses. 1
Supporting Evidence
Animal reproduction studies at doses up to 6,400 mg/kg/day in mice (6.3 times the maximum human dose) and 400 mg/kg/day in rabbits (2.1 times the maximum human dose) revealed no evidence of impaired fertility or fetal harm. 2
Human clinical data from a prospective cohort study of 106 women exposed to cefuroxime during the first trimester showed no increased risk of major malformations (3.2% vs 2% in controls, p=0.61). 3
Long-term developmental assessment of 80 infants born to mothers treated with cefuroxime during pregnancy (13 in first trimester, 19 in second, 46 in third) showed no physical or mental developmental abnormalities attributable to the medication over 18 months of follow-up. 4
Clinical Applications During Pregnancy
Cefuroxime is recommended as a first-line option for bacterial infections in pregnancy, including:
- Respiratory tract infections - explicitly listed as compatible throughout all trimesters 1
- Acute pyelonephritis - demonstrated superior efficacy compared to first-generation cephalosporins, with faster clinical recovery (2.7 vs 3.1 days) and higher bacteriological cure rates (78.8% vs 59.2%). 5
- Surgical prophylaxis - recommended by French guidelines for cardiac, vascular, and orthopedic procedures during pregnancy 1
Pharmacokinetic Considerations
Pregnancy alters cefuroxime pharmacokinetics, requiring attention to dosing:
- Plasma levels are significantly lower during pregnancy compared to postpartum 6
- Drug half-life is shorter and clearance is higher during pregnancy 6
- Standard dosing of 500 mg every 8 hours intramuscularly has been validated for acute pyelonephritis in pregnant women 7
- Cefuroxime crosses the placenta, with demonstrable levels in cord blood and amniotic fluid 6
Breastfeeding
Cefuroxime is compatible with breastfeeding. 1 The drug is excreted in human milk, but caution should be exercised as with any medication during lactation. 2 Most systemic antibiotics present in breast milk could theoretically cause falsely negative cultures in febrile infants or produce gastroenteritis due to alteration of intestinal flora. 1
Important Clinical Caveats
- No adequate well-controlled studies exist in pregnant women, so the drug should be used only if clearly needed, though extensive clinical experience supports safety. 2
- Cefuroxime offers advantages over older beta-lactams due to lower resistance rates among uropathogens (1% vs 14% for cephradine). 5
- All cephalosporins as a class are considered low-risk options during pregnancy, making cefuroxime part of a broader safe antibiotic category. 1, 8