Is MOXCLAV (amoxicillin-clavulanic acid) contraindicated in pregnancy?

Amoxicillin-Clavulanic Acid (MOXCLAV) Safety in Pregnancy

Amoxicillin-clavulanic acid is not contraindicated in pregnancy and can be safely used at any stage, including just before delivery, as current evidence indicates no increased risk of fetal harm.

Safety Profile

Amoxicillin-clavulanic acid is classified as Pregnancy Category B by the FDA 1, indicating:

• Reproduction studies in pregnant rats and mice showed no evidence of fetal harm at doses up to 4.9 times the maximum human dose 1
• No adequate and well-controlled studies show increased risk in pregnant women 1

Evidence Supporting Safety:

1. FDA Labeling: The official drug label states that animal reproduction studies revealed no evidence of harm to the fetus due to amoxicillin and clavulanic acid 1

2. Recent Research: The most recent comprehensive study (2019) examined 101,615 pregnancies, including 6,041 with first-trimester exposure to amoxicillin-clavulanic acid, finding:

   • No significant association with major congenital malformations (adjusted relative risk 1.09,95% CI 0.98-1.20)
   • No dose-response relationship between exposure and malformations 2

3. Specific Concerns Addressed: A 2022 study specifically examining late pregnancy use concluded that available data do not support an increased risk of necrotizing enterocolitis with amoxicillin-clavulanic acid use in late pregnancy 3

Clinical Considerations

Appropriate Use:

• Amoxicillin-clavulanic acid should be used during pregnancy only when clearly needed 1
• It is considered among the safer antibiotic options during pregnancy, along with other penicillins and cephalosporins 4

Monitoring:

• As with all antibiotics during pregnancy, clinical response should be evaluated within 48-72 hours of initiating therapy 4
• Ampicillin-class antibiotics (including amoxicillin) are excreted in breast milk, so caution should be exercised when administered to nursing women 1

Comparative Safety:

When considering antibiotic choices during pregnancy:

• Penicillins and cephalosporins are considered the safest antibiotic classes 4
• Tetracyclines, fluoroquinolones, and trimethoprim-sulfamethoxazole should be avoided due to established risks 4

Conclusion

The totality of evidence from multiple sources, including the FDA drug label 1, recent large-scale studies 2, and specific investigations of late-pregnancy use 3, consistently demonstrates that amoxicillin-clavulanic acid is not contraindicated in pregnancy.

While any medication during pregnancy should be used only when the potential benefit justifies the risk, amoxicillin-clavulanic acid has a favorable safety profile and can be prescribed at any stage of pregnancy when clinically indicated.