Sharon Daniel1,2,3, Maya Doron1,2, Boris Fishman1,2, Gideon Koren4, Eitan Lunenfeld5,2,6, Amalia Levy1,2. 1. Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 2. Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 3. Clalit Health Services (Southern District), Beer-Sheva, Israel. 4. Ariel University, Israel. 5. Department of Obstetrics and Gynecology, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 6. Soroka Medical Center, Beer-Sheva, Israel.
Abstract
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.
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.
Authors: B Mulder; K B Pouwels; C C M Schuiling-Veninga; H J Bos; T W de Vries; S S Jick; E Hak Journal: Clin Exp Allergy Date: 2016-06-13 Impact factor: 5.018
Authors: William O Cooper; Sonia Hernandez-Diaz; Patrick G Arbogast; Judith A Dudley; Shannon M Dyer; Patricia S Gideon; Kathleen S Hall; Lisa A Kaltenbach; Wayne A Ray Journal: Paediatr Perinat Epidemiol Date: 2009-01 Impact factor: 3.980