The safety of Amoxicillin and Clavulanic acid use during the first trimester of Pregnancy
The British Pharmacological Society Journal: Published: 05 September 2019
Penicillin’s are widely used during pregnancy for various bacterial infectious indications. Amoxicillin, rapidly crosses the placenta following absorption to the bloodstream, It is prescribed both as a sole medicine as well as in combination with clavulanic acid mostly for the treatment of urinary tract and respiratory infections.
The primary goal of the current study was to assess the risk for major malformations following exposure to either amoxicillin or amoxicillin with clavulanic acid using a large population-based cohort study.
TAKE HOME MESSAGE:
What is already known about this subject?
Recent studies have suggested that changes in the microbiome induced by antibiotics, may affect the pregnancy outcome.
In recent years, there is accumulating evidence that gestational exposure to antibiotics may have adverse effects on children, probably through changes in the gut microbiome.
These findings raise a concern regarding the association between a change in maternal microbiome during pregnancy and major malformations.
What this study adds?
This study suggests that the antibiotics studied are not associated with increased risk of birth malformations.
First-trimester exposure to amoxicillin and amoxicillin with clavulanic acid is not associated with increased risk for major congenital malformations in general, or with specific major congenital malformations related to organ systems.
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Aims
The goal of the current study was to assess the risk for major congenital malformations following first-trimester exposure to amoxicillin, or amoxicillin and clavulanic acid (ACA).
Methods
A population-based retrospective cohort study was conducted, by linking 4 computerized databases: maternal and infant hospitalization records, drug dispensing database of Clalit Health Services in Israel and data concerning pregnancy terminations. Multivariate negative-binomial regression was used to assess the risk for major malformations following first-trimester exposure, adjusted for mother's age, ethnicity (Bedouin vs Jewish), parity, diabetes mellitus, lack of perinatal care, and the year of birth.
Results
The study included 101 615 pregnancies, of which 6919 (6.8%) were exposed to amoxicillin: 1045 (1.0%) to amoxicillin only and 6041 (5.9%) to ACA. No significant association was found, in the univariate and multivariate analyses, between first-trimester exposure to amoxicillin or ACA and major malformations in general (crude relative risk, 1.05 95% confidence interval 0.95–1.16; adjusted relative risk 1.09, 95% confidence interval 0.98–1.20), or for major malformations according to organ systems. No dose–response relationship was found between exposure in terms of the defined daily dose and major malformations.
Conclusion
Exposure to amoxicillin and ACA during the first trimester of pregnancy was not associated with an increased risk of major congenital malformations.
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