Is Augmentin (amoxicillin-clavulanate) safe to use during pregnancy?

Safety of Augmentin During Pregnancy

Augmentin (amoxicillin-clavulanate) is safe to use during pregnancy when clinically indicated for bacterial infections, as the benefits of treating maternal infections generally outweigh the theoretical risks to the fetus. 1, 2

Evidence for Safety

• Amoxicillin-clavulanate is categorized as "Compatible" for use during pregnancy by clinical practice guidelines 1
• According to the FDA drug information, reproduction studies performed in mice and rats at doses up to 2000 mg/kg showed no evidence of harm to the fetus due to amoxicillin 3
• A population-based case-control study found that augmentin treatment during pregnancy is unlikely to increase the risk of congenital abnormalities in newborns 4
• Untreated infections during pregnancy can lead to significant complications including preterm birth, low birth weight, and spontaneous abortion, making appropriate antibiotic treatment important 2

Special Considerations

• While generally safe, Augmentin should be used during pregnancy only when clearly needed, as there are no adequate and well-controlled studies specifically in pregnant women 3
• Augmentin is not recommended in women at risk of preterm delivery due to a very low risk of necrotizing enterocolitis in the fetus 1
• Oral ampicillin (a component of Augmentin) is poorly absorbed during labor, and it's not known whether its use during labor or delivery has immediate or delayed adverse effects on the fetus 3

Use During Breastfeeding

• Penicillins, including amoxicillin, are excreted in human milk 3
• Augmentin is considered compatible with breastfeeding according to clinical guidelines 1
• Caution should be exercised when administering to nursing women as it may lead to sensitization of infants 3

Clinical Decision-Making Algorithm

1. Confirm the need for antibiotic therapy based on clinical presentation and, when possible, culture results 1
2. Consider Augmentin as a safe first-line option for appropriate infections during pregnancy 1, 2
3. For women at risk of preterm delivery, consider alternative antibiotics if clinically appropriate 1
4. When prescribing Augmentin during pregnancy, use the standard therapeutic doses as there is no evidence of increased risk at these levels 4
5. Monitor for common side effects that may occur with Augmentin use, as would be done in non-pregnant patients 3

Potential Drug Interactions During Pregnancy

• Probenecid can decrease the renal tubular secretion of amoxicillin, potentially resulting in increased and prolonged blood levels 3
• Concurrent use with oral anticoagulants may require monitoring and dose adjustments due to potential prolongation of prothrombin time 3
• Augmentin may affect intestinal flora, potentially leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives 3

Augmentin represents a safe antibiotic choice during pregnancy when treatment of bacterial infections is indicated, with substantial evidence supporting its use and minimal risk to the developing fetus.