From the FDA Drug Label
8.1 Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg/125 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Key Points:
- The drug label indicates that Augmentin (amoxicillin-clavulanate) is classified as Pregnancy Category B.
- Animal studies have shown no evidence of harm to the fetus, but no adequate and well-controlled studies have been conducted in pregnant women.
- The label advises that the drug should be used during pregnancy only if clearly needed.
Based on the information provided, Augmentin (amoxicillin-clavulanate) can be used in pregnancy, but only if clearly needed, due to the lack of adequate and well-controlled studies in pregnant women 1.
From the Research
Safety of Augmentin in Pregnancy
The safety of Augmentin (amoxicillin-clavulanate) in pregnancy has been evaluated in several studies.
- A study published in 2022 2 found that the results available to date do not support an increased risk of necrotizing enterocolitis with the use of amoxicillin-clavulanic acid in late pregnancy.
- Another study published in 2019 3 found no significant association between first-trimester exposure to amoxicillin or amoxicillin and clavulanic acid (ACA) and major malformations in general.
- A population-based case-control teratologic study published in 2001 4 found that augmentin treatment during pregnancy is unlikely to increase the risk of congenital abnormalities in newborn infants.
- A prospective, controlled study published in 2004 5 found that exposure to amoxycillin/clavulanic acid during pregnancy is unlikely to be associated with an increased risk of malformations.
- A systematic review published in 2023 6 found that although no major congenital anomaly was reported for the administration of amoxicillin consumption with or without clavulanic acid, there is a possibility that amoxicillin administration in pregnancy might be related to some anomalies, including cleft palate.
Key Findings
- The majority of the studies found no increased risk of congenital abnormalities or malformations associated with the use of Augmentin in pregnancy.
- One study found a possible relationship between amoxicillin administration in pregnancy and cleft palate 6.
- The studies suggest that Augmentin can be prescribed at any stage of pregnancy, including just before delivery, when clinically indicated 2.