Safety of Augmentin (Amoxicillin-Clavulanate) During Pregnancy
Augmentin is safe to use during pregnancy when clinically indicated, as there is no evidence of increased risk of congenital abnormalities or adverse pregnancy outcomes. 1, 2
Evidence for Safety
Amoxicillin-clavulanic acid (Augmentin) is considered safe for use during pregnancy based on multiple lines of evidence:
- The FDA drug label states that reproduction studies in mice and rats at doses up to 2000 mg/kg showed no evidence of harm to the fetus due to amoxicillin 2
- The 2024 Gastroenterology clinical practice guidelines explicitly state that "amoxicillin-clavulanic acid is safe and can also be administered during pregnancy" 1
- A population-based case-control study found that Augmentin treatment during pregnancy is unlikely to increase the risk of congenital abnormalities in newborn infants 3
Considerations When Using Augmentin in Pregnancy
While Augmentin is considered safe, there are some important considerations:
- As with all medications during pregnancy, it should be used when clearly needed and when the benefit outweighs any potential risk 2
- Penicillins are excreted in breast milk, which may lead to sensitization of infants, so caution should be exercised during breastfeeding 2
- There is a small theoretical concern about amoxicillin with clavulanic acid in women at risk of preterm delivery, though this risk is considered very low 1
Specific Clinical Scenarios
Augmentin is particularly appropriate in the following situations during pregnancy:
- For treatment of respiratory, urinary tract, and skin/skin structure infections 2
- In cases of pouchitis or intra-abdominal abscesses resulting from fistulizing Crohn's disease 1
- As an alternative to other antibiotics that are contraindicated during pregnancy (such as tetracyclines) 1
Monitoring and Precautions
When using Augmentin during pregnancy:
- No special monitoring is required specifically for the pregnancy
- Standard monitoring for antibiotic side effects (allergic reactions, gastrointestinal symptoms) should be performed
- If the patient is also taking oral contraceptives, be aware that amoxicillin may affect intestinal flora, potentially reducing the efficacy of combined oral contraceptives 2
Alternative Antibiotics During Pregnancy
If Augmentin is not appropriate, other antibiotics with established safety profiles in pregnancy include:
- Amoxicillin alone (without clavulanic acid)
- Cephalosporins (e.g., cefuroxime) 1
- Azithromycin (though with a very low risk of hypertrophic pyloric stenosis in infants if used during breastfeeding in the first 13 days) 1
Remember that certain antibiotics should be avoided during pregnancy, including tetracyclines (associated with tooth discoloration and bone growth suppression) and fluoroquinolones (though human data suggest low risk, animal studies show potential for fetal cartilage damage) 1.