Augmentin Safety in Pregnancy
Augmentin (amoxicillin-clavulanate) is safe to use throughout pregnancy when clinically indicated for bacterial infections, as the benefits of treating maternal infections outweigh theoretical fetal risks. 1, 2
Safety Classification and Evidence Base
- The European Respiratory Society/Thoracic Society of Australia and New Zealand categorizes amoxicillin/clavulanate as "Compatible" for use during pregnancy 1
- Reproduction studies in mice and rats at doses up to 3-6 times the human dose showed no evidence of fetal harm 3
- A large population-based case-control study of 6,935 cases and 10,238 controls found no increased risk of congenital abnormalities with Augmentin use during pregnancy (odds ratio 1.4,95% CI 0.9-2.0) 4
Clinical Decision-Making Algorithm
When to Use:
- Augmentin can be prescribed throughout all trimesters of pregnancy for appropriate bacterial infections 1
- The American College of Gastroenterology supports its use when clinically indicated, as untreated infections pose significant risks including preterm birth, low birth weight, and spontaneous abortion 2
Critical Exception - When NOT to Use:
- Do not prescribe Augmentin in women at risk of preterm delivery due to a very low but documented risk of necrotizing enterocolitis in the fetus 1
- In these patients, select alternative antibiotics when clinically appropriate 1
Risk-Benefit Analysis
Maternal infection risks if untreated: 2
- Preterm birth
- Low birth weight
- Spontaneous abortion
Fetal safety profile:
- No increased occurrence of fetal malformations in reproduction studies 1
- Large epidemiological data supports safety profile 4
Breastfeeding Compatibility
- Amoxicillin/clavulanate is considered compatible with breastfeeding by the ERS/TSANZ task force 1
- Penicillins are excreted in human milk and may lead to infant sensitization, requiring monitoring 3
Common Pitfalls to Avoid
- Do not withhold appropriate antibiotic therapy due to pregnancy concerns when maternal infection is present—untreated infections pose greater risks than the medication 2
- Screen for preterm delivery risk before prescribing, as this is the only contraindication requiring alternative antibiotic selection 1
- The FDA label states "should be used during pregnancy only if clearly needed" 3, but this conservative language predates more recent guideline evidence supporting routine use when indicated 1, 2