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

Safety of Augmentin During Pregnancy

Augmentin (amoxicillin-clavulanate) is considered safe and compatible with pregnancy, with no evidence of increased risk of fetal malformations or harmful effects. 1

Evidence-Based Safety Profile

Augmentin is classified as FDA Pregnancy Category B, indicating that:

• Animal reproduction studies have failed to demonstrate a risk to the fetus
• There are no adequate and well-controlled studies in pregnant women showing adverse effects 2

The European Respiratory Society/TSANZ task force specifically lists amoxicillin-clavulanic acid as "compatible" with pregnancy, meaning it is considered a first-choice medication that should be tolerated during pregnancy based on sufficient evidence through use during human pregnancies 1.

Clinical Research Support

A population-based case-control teratologic study specifically examining Augmentin use during pregnancy found:

• No increased risk of congenital abnormalities when used during pregnancy
• No higher use of Augmentin in any congenital abnormality group when comparing treatment during the critical second-third months of pregnancy 3

The study concluded that "Augmentin treatment of pregnant women in usual therapeutic doses is unlikely to increase the risk of congenital abnormalities in newborn infants." 3

Important Considerations

Timing Considerations

While generally safe throughout pregnancy, there is one specific caution:

• Amoxicillin+clavulanic acid is not recommended in women at risk of pre-term delivery due to a very low risk of necrotizing enterocolitis in the fetus 1

Breastfeeding Compatibility

• Penicillins, including amoxicillin, are excreted in human milk
• While generally considered compatible with breastfeeding, caution should be exercised as it may lead to sensitization of infants 2

Potential Side Effects to Monitor

While not specific to pregnancy, common side effects of Augmentin that should be monitored include:

• Gastrointestinal effects (diarrhea, nausea, vomiting)
• Allergic reactions
• Potential for antibiotic-associated diarrhea

Clinical Decision Algorithm

1. First-line antibiotic choice: When an antibiotic is indicated during pregnancy, Augmentin can be considered a first-line option due to its established safety profile
2. Risk-benefit assessment: The benefit of treating bacterial infections typically outweighs the minimal risks of Augmentin use in pregnancy
3. Gestational age consideration:
   • Safe throughout pregnancy
   • Use with caution if there is risk of preterm delivery
4. Alternative consideration: If there is a history of allergic reaction to penicillins, alternative antibiotics should be selected

Conclusion for Clinical Practice

When treating bacterial infections during pregnancy, Augmentin represents a safe antibiotic option with minimal risk to the developing fetus. The evidence supports its use when clinically indicated, as untreated maternal infections may pose greater risks to both maternal and fetal health than the medication itself.