Can pregnant women take Augmentin (amoxicillin-clavulanate)?

Safety of Augmentin (Amoxicillin-Clavulanate) During Pregnancy

Augmentin (amoxicillin-clavulanate) is considered safe for use during pregnancy when clinically indicated, as it falls under FDA Pregnancy Category B, indicating no evidence of risk to the fetus in animal studies and no adequate studies showing risk in pregnant women.

Evidence for Safety

The FDA drug label for amoxicillin-clavulanate clearly states that reproduction studies in pregnant rats and mice given amoxicillin and clavulanate potassium revealed no evidence of harm to the fetus 1. Specifically:

• Animal studies using doses up to 4 times the maximum recommended human dose for amoxicillin and 9 times for clavulanate showed no teratogenic effects
• The medication is classified as Pregnancy Category B
• While there are no adequate and well-controlled studies in pregnant women, the safety profile is reassuring

A population-based case-control study found no increased risk of congenital abnormalities in infants whose mothers took Augmentin during pregnancy 2. The study compared 6,935 pregnant women who had offspring with congenital abnormalities to 10,238 pregnant women who had babies without defects, finding no significant difference in Augmentin use between groups.

Clinical Considerations

When prescribing Augmentin during pregnancy, healthcare providers should consider:

1. Indication for use: Ensure the infection requires treatment and Augmentin is an appropriate choice
2. Timing of treatment: The medication can be used throughout pregnancy when indicated
3. Dosing: Standard adult dosing is generally appropriate, though physiologic changes in pregnancy may affect pharmacokinetics 3
4. Duration: Use the shortest effective course of therapy

Alternatives for Penicillin-Allergic Patients

For pregnant women with penicillin allergy, alternative options depend on the severity of the allergy:

• For non-severe allergies: Cephalosporins may be considered as they are also considered first-line antibiotics during pregnancy 4
• For severe allergies (anaphylaxis, angioedema): Options depend on the specific infection being treated and should be guided by susceptibility testing

Specific Infection Considerations

For Chlamydia Infections

While Augmentin is not a first-line treatment for chlamydia in pregnancy, the CDC recommends:

• Azithromycin 1g orally in a single dose as first-line therapy
• Amoxicillin 500 mg orally three times daily for 7 days as an alternative 5

For Group B Streptococcal Prophylaxis

For intrapartum prophylaxis, the CDC recommends:

• Penicillin G or ampicillin as first-line agents
• For penicillin-allergic patients without anaphylaxis history: cefazolin
• For penicillin-allergic patients with anaphylaxis history: clindamycin (if susceptible) or vancomycin 6

Potential Concerns

While Augmentin is generally considered safe, healthcare providers should be aware that:

• Amoxicillin is excreted in breast milk, which could potentially lead to sensitization of infants 1
• The medication is substantially excreted by the kidneys, so dose adjustment may be needed in patients with impaired renal function 1
• As with any medication during pregnancy, the benefits should outweigh potential risks

Conclusion

Based on available evidence, Augmentin is considered safe for use during pregnancy when clinically indicated. The FDA Pregnancy Category B classification and population-based studies support its safety profile. However, as with all medications during pregnancy, it should be used only when clearly needed, with the lowest effective dose for the shortest duration necessary.