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

Safety of Augmentin (Amoxicillin/Clavulanate) During Pregnancy

Augmentin (amoxicillin/clavulanate) is generally safe to use during pregnancy as it has not been associated with an increased risk of congenital abnormalities. 1, 2, 3

Classification and Safety Profile

• Amoxicillin/clavulanate is classified as FDA Pregnancy Category B, indicating that animal reproduction studies have failed to demonstrate a risk to the fetus, and there are no adequate well-controlled studies in pregnant women 2
• Population-based case-control studies have shown that Augmentin treatment during pregnancy is unlikely to increase the risk of congenital abnormalities in newborn infants 3
• The European Respiratory Society/Thoracic Society of Australia and New Zealand (ERS/TSANZ) task force categorizes amoxicillin/clavulanate as "Compatible" for use during pregnancy 1

Recommendations for Use During Pregnancy

• Amoxicillin/clavulanate can be used throughout pregnancy when clinically indicated for bacterial infections 1
• The benefit of treating maternal infections with Augmentin generally outweighs the theoretical risks to the fetus 1
• When prescribing any medication during pregnancy, including Augmentin, clinicians should compare the benefits and risks, considering both maternal disease control and fetal safety 1

Special Considerations

• Augmentin is not recommended in women at risk of preterm delivery due to a very low risk of necrotizing enterocolitis in the fetus 1
• Animal reproduction studies have shown no evidence of harm to the fetus due to amoxicillin at doses up to 3-6 times the human dose 2
• Reproduction studies specifically for the combination of amoxicillin and clavulanate have shown no increased occurrence of fetal malformations or harmful effects 1

Use During Breastfeeding

• Penicillins, including amoxicillin, are excreted in human milk 2
• While generally considered compatible with breastfeeding, caution should be exercised as exposure through breast milk may lead to sensitization of infants 2
• The ERS/TSANZ task force considers amoxicillin/clavulanate compatible with breastfeeding 1

Potential Adverse Effects

• As with all antibiotics, there is a theoretical risk of altering the infant's gut microbiome if used during breastfeeding 2
• Common side effects of Augmentin that may occur during pregnancy (as in non-pregnant individuals) include gastrointestinal symptoms like diarrhea, nausea, and vomiting 2
• Rarely, allergic reactions can occur, which should be promptly addressed 2

Clinical Decision-Making Algorithm

1. Confirm the need for antibiotic therapy based on clinical presentation and, when possible, culture results
2. Consider Augmentin as a safe first-line option for appropriate infections during pregnancy 1
3. Use the standard recommended dosage as pregnancy does not typically require dose adjustment 2
4. Monitor for typical side effects as would be done in non-pregnant patients
5. If treating women at risk of preterm delivery, consider alternative antibiotics if clinically appropriate 1

In conclusion, current evidence supports the use of Augmentin during pregnancy when clinically indicated, with the benefits of treating maternal infection generally outweighing the potential risks to the fetus.