amoxicillin-potassium-clavulanate-combination and Abnormalities--Drug-Induced

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).. 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.. 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.. Exposure to amoxicillin and ACA during the first trimester of pregnancy was not associated with an increased risk of major congenital malformations.

Topics: Abnormalities, Drug-Induced; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acid; Cohort Studies; Dose-Response Relationship, Drug; Female; Humans; Infant, Newborn; Multivariate Analysis; Pregnancy; Pregnancy Trimester, First; Retrospective Studies; Risk Factors

To study the human teratogenic potential of augmentin (amoxicillin+clavulanic acid) treatment during pregnancy.. Pair analysis of cases with different congenital abnormalities and their matched controls in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, between 1991 and 1996.. The case group included 6935 pregnant women who had offspring with congenital abnormalities, while the control group consisted of 10,238 pregnant women who had babies without any defects. The number (and rate) of pregnant women with augmentin treatment was 52 (0.75%) and 56 (0.55%) in the case and control groups, respectively (crude odds ratio (OR) with 95% confidence interval (CI) was 1.4, 0.9-2.0). The comparison of augmentin treatments during the second-third months of pregnancy (i.e. in the critical period for most major congenital abnormalities) in case-control pairs did not show a higher use of augmentin in any congenital abnormality group.. Augmentin treatment of pregnant women in usual therapeutic doses is unlikely to increase the risk of congenital abnormalities in newborn infants. However, the number of cases and controls was limited, therefore, further multicenter-multinational studies are needed for the final risk assessment.

Topics: Abnormalities, Drug-Induced; Adult; Amoxicillin-Potassium Clavulanate Combination; Case-Control Studies; Congenital Abnormalities; Drug Therapy, Combination; Female; Gestational Age; Heart Defects, Congenital; Humans; Odds Ratio; Pregnancy; Pregnancy Complications