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Drug Safety

, Volume 35, Issue 7, pp 589–598 | Cite as

The Outcomes of Pregnancy in Women Exposed to the New Macrolides in the First Trimester

A Prospective, Multicentre, Observational Study
  • Benjamin Bar-Oz
  • Corinna Weber-Schoendorfer
  • Maya Berlin
  • Maurizio Clementi
  • Elena Di Gianantonio
  • Loes de Vries
  • Marco De Santis
  • Paul Merlob
  • Bracha Stahl
  • Giorgio Eleftheriou
  • Eva Maňáková
  • Lucie Hubičková-Heringová
  • Ilan YoungsterEmail author
  • Matitiahu Berkovitch
Original Research Article

Abstract

Background: Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy.

Objective: The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic preparations.

Methods; In this prospective, multinational, multicentre, controlled, observational study, information was obtained either from pregnant women or their healthcare professionals who contacted their local teratogen information services in Italy, Israel, the Czech Republic, the Netherlands and Germany seeking information after exposure to macrolides. The comparison group included women or their healthcare professional who contacted these centreswithquestionsregardingknownnon-teratogenicpreparations. Information on obstetric and other background parameters was collected at enrollment; after delivery, subjects or their healthcare professionals were contacted to ascertain pregnancy outcome parameters and other exposures through the remainder of the pregnancy.

Results: A total of 608 women exposed to macrolides during pregnancy were enrolled; 511 of the exposures occurred during the first trimester. The comparison group comprised 773 women exposed to non-teratogenic preparations during the first trimester of pregnancy. No significant difference in the rate of major congenital malformations was found between the study group and the comparison group (3.4% vs 2.4%; p = 0.36; odds ratio (OR) 1.42; 95% CI 0.70, 2.88) or in the rate of cardiovascular malformations (1.6% vs 0.9%; p = 0.265; OR 1.91; 95% CI 0.63, 5.62).

No significant differences were found between subgroups of macrolides in the rates of major congenital malformations or cardiac malformations, although for azithromycin this was of borderline significance.

Conclusions: This study, in agreement with earlier smaller studies, suggests that the new macrolides do not pose a significantly increased risk of major congenital malformations or cardiac malformations.

Keywords

Live Birth Clarithromycin Azithromycin Macrolides Ventricular Septal Defect 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

The first two authors have equally contributed to the manuscript. The authors state that no financial support or author involvement with organizations with financial interest in the subject matter exists, and that no actual or potential conflict of interest exists.

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Copyright information

© Adis Springer International Publishing AG 2012

Authors and Affiliations

  • Benjamin Bar-Oz
    • 1
  • Corinna Weber-Schoendorfer
    • 2
  • Maya Berlin
    • 3
  • Maurizio Clementi
    • 4
  • Elena Di Gianantonio
    • 4
  • Loes de Vries
    • 5
  • Marco De Santis
    • 6
  • Paul Merlob
    • 7
  • Bracha Stahl
    • 7
  • Giorgio Eleftheriou
    • 8
  • Eva Maňáková
    • 9
  • Lucie Hubičková-Heringová
    • 9
  • Ilan Youngster
    • 3
    Email author
  • Matitiahu Berkovitch
    • 3
  1. 1.Department of NeonatologyHadassah and Hebrew University Medical CenterJerusalemIsrael
  2. 2.Pharmakovigilanzzentrum EmbryonaltoxikologieBBGes/Charité Universitätsmedizin BerlinBerlinGermany
  3. 3.Clinical Pharmacology and Toxicology Unit, Teratogen Information Service, Assaf Harofeh Medical Center, Sackler School of MedicineTel Aviv UniversityTel AvivIsrael
  4. 4.Servizio Informazione Teratologica, Genetica, Clinica et EpidemiologicaUniversity of PadovaPadovaItaly
  5. 5.Teratology Information ServiceNational Institute of Public Health and EnvironmentBilthoventhe Netherlands
  6. 6.Department of Obstetrics & GynecologyCatholic University of Sacred HeartRomeItaly
  7. 7.Beilinson Teratology Information Service, Rabin Medical Center, Sackler School of MedicineTel Aviv University, Beilinson CampusTel AvivIsrael
  8. 8.Department of Clinical PharmacologyCentro antiveleni-Tossicologia clinicaBergamoItaly
  9. 9.Division of Histology and EmbryologyCenter of Biomedical Sciences, Faculty of Medicine, Charles UniversityPragueCzech Republic

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