A E Czeizel1, M Rockenbauer, H T Sørensen, J Olsen. 1. Foundation for the Community Control of Hereditary Diseases, Department of Human, Genetics and Teratology, National Center for Epidemiology, 1026 Budapest, Törökvész lejtõ 32, Budapest, Hungary. czeizel@mail.interware.hu
Abstract
OBJECTIVE: To study the human teratogenic potential of augmentin (amoxicillin+clavulanic acid) treatment during pregnancy. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: To study the human teratogenic potential of augmentin (amoxicillin+clavulanic acid) treatment during pregnancy. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: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.
Authors: Peter Jepsen; Mette V Skriver; Andrea Floyd; Loren Lipworth; Henrik C Schønheyder; Henrik T Sørensen Journal: Br J Clin Pharmacol Date: 2003-02 Impact factor: 4.335