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

Is Augmentin Safe in Pregnancy?

Yes, Augmentin (amoxicillin-clavulanate) is safe to use throughout pregnancy when clinically indicated for bacterial infections. 1, 2

Safety Classification and Evidence Base

Augmentin is classified as FDA Pregnancy Category B, meaning reproduction studies in pregnant rats and mice at doses up to 1200 mg/kg/day (approximately 4 times the maximum human dose for amoxicillin and 9 times for clavulanate) revealed no evidence of fetal harm 2. The European Respiratory Society/Thoracic Society of Australia and New Zealand categorizes amoxicillin-clavulanate as "Compatible" for use during pregnancy 1.

When to Use Augmentin in Pregnancy

Augmentin can be prescribed throughout all trimesters of pregnancy when treating bacterial infections 1. The benefit of treating maternal infections generally outweighs theoretical risks to the fetus 1. Beta-lactam antibiotics like Augmentin have a long history of safe use without significant deleterious effects on fetuses 3.

Supporting Evidence

• A population-based case-control study of 6,935 cases with congenital abnormalities versus 10,238 controls found no increased risk of congenital abnormalities with Augmentin treatment during pregnancy (crude OR 1.4,95% CI 0.9-2.0) 4
• Comparison of Augmentin use during the critical second-third months of pregnancy showed no higher use in any congenital abnormality group 4

Critical Exception: Preterm Delivery Risk

Augmentin is NOT recommended in women at risk of preterm delivery due to a very low but documented risk of necrotizing enterocolitis in the fetus 1. If treating women with preterm labor risk, consider alternative antibiotics when clinically appropriate 1.

Clinical Decision Algorithm

1. Confirm bacterial infection requiring antibiotic therapy based on clinical presentation and culture results when possible 1

2. Assess preterm delivery risk factors:

   • If present: Consider alternative antibiotics 1
   • If absent: Augmentin is safe to use 1

3. Prescribe standard therapeutic doses - no dosage adjustment needed for pregnancy alone 2

4. Continue throughout pregnancy as needed - there is no evidence-based reason to discontinue at 32 weeks or any other gestational age 5

Use During Breastfeeding

Augmentin is compatible with breastfeeding 1. While amoxicillin is excreted in human milk and may lead to infant sensitization, this is not a contraindication to use 2. Caution should be exercised, but breastfeeding can continue 2.

Important Caveats

• No drug is completely without risk - the decision should weigh benefits of treating maternal infection against theoretical risks 6
• Renal impairment requires dose adjustment - amoxicillin is primarily eliminated by the kidney, so patients with severe renal impairment (GFR <30 mL/min) need dosage modification 2
• Inform patients of the safety profile - counseling should enable realistic risk assessment without causing undue anxiety 7