Document Detail

Fetal safety of macrolides.
MedLine Citation:
PMID:  23650169     Owner:  NLM     Status:  MEDLINE    
Macrolide antibiotics are largely used in pregnancy for different bacterial infections. Their fetal safety has been studied by several groups, yielding opposing results. In particular, there have been studies claiming an association between macrolides and cardiovascular malformations. Exposure in early infancy has been associated with pyloric stenosis and intussusception. This has led to an avoidance in prescribing macrolides to pregnant women in several Scandinavian countries. The Objectives of the present study was to investigate the fetal safety of this class of drug by linking a large administrative database of drug dispensing and pregnancy outcome in Southern Israel. A computerized database of medications dispensed from 1999 to 2009 to all women registered in the Clalit health maintenance organization in southern Israel was linked with two computerized databases containing maternal and infant hospitalization records. Also, medical pregnancy termination data were analyzed. The following confounders were controlled for: maternal age, ethnicity, maternal pregestational diabetes, parity, and the year the mother gave birth or went through medical pregnancy termination. First- and third-trimester exposures to macrolide antibiotics as a group and to individual drugs were analyzed. During the study period there were 105,492 pregnancies among Clalit women that met the inclusion criteria. Of these, 104,380 ended in live births or dead fetuses and 1,112 in abortion due to medical reasons. In the first trimester of pregnancy, 1,033 women were exposed to macrolides. There was no association between macrolides and either major malformations [odds ratio (OR), 1.08; 95% confidence interval (CI), 0.84 to 1.38)] or specific malformations, after accounting for maternal age, parity, ethnicity, prepregnancy diabetes, and year of exposure. During the third trimester of pregnancy, 959 women were exposed to macrolides. There was no association between such exposure and perinatal mortality, low birth weight, low Apgar score, or preterm delivery. Similarly, no associations were demonstrated with pyloric stenosis or intussusception. Use of macrolides in the first trimester of pregnancy is not associated with an increased risk of major malformations. Exposure in the third trimester is not likely to increase neonatal risks for pyloric stenosis or intussusception in a clinically meaningful manner.
Anat Bahat Dinur; Gideon Koren; Ilan Matok; Arnon Wiznitzer; Elia Uziel; Rafael Gorodischer; Amalia Levy
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Publication Detail:
Type:  Journal Article     Date:  2013-05-06
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  57     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-13     Completed Date:  2013-12-31     Revised Date:  2014-01-09    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3307-11     Citation Subset:  IM    
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MeSH Terms
Abnormalities, Drug-Induced*
Anti-Bacterial Agents / adverse effects
Bacterial Infections / drug therapy
Cardiovascular Abnormalities / chemically induced*
Cohort Studies
Infant, Newborn
Intussusception / chemically induced*
Macrolides / adverse effects*,  therapeutic use
Middle Aged
Perinatal Mortality
Pregnancy Complications, Infectious / drug therapy
Pregnancy Outcome
Pregnancy Trimester, First
Pyloric Stenosis / chemically induced*
Registries / statistics & numerical data
Retrospective Studies
Young Adult
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Macrolides

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