Drug Safety

, Volume 31, Issue 9, pp 775–788 | Cite as

Risk of Hypospadias in Offspring of Women Using Loratadine during Pregnancy

A Systematic Review and Meta-Analysis
  • Eleanor B. Schwarz
  • Myla E. Moretti
  • Smita Nayak
  • Gideon Koren
Original Research Article

Abstract

Background: Loratadine, a second-generation antihistamine, is commonly used to treat seasonal allergies. Some studies have suggested that use of loratadine by pregnant women increases the risk of hypospadias in male offspring.

Objective: This meta-analysis was designed to assess the strength of the association between loratadine and hypospadias.

Methods: To locate pertinent articles published in any language from January 1989 until August 2007, we searched electronic databases (MEDLINE, OVID, EMBASE, SCOPUS, TOXLINE Special, ReproTox, TERIS, CINAHL and others), conference proceedings and bibliographies. Studies were eligible for this analysis if they were cohort, case-control or case series studies that reported the incidence of hypospadias in the offspring of women who were or were not exposed to loratadine during pregnancy. Two authors independently extracted information on study design, participant characteristics, measures of outcome, control for potential confounding factors and risk estimates using a standardized data collection form. The Newcastle-Ottawa Scale was then used to assess the quality of each study. We used a random-effects meta-analysis model to combine the risk data.

Results: In 1402 potentially relevant titles, we found three case-control studies and seven cohort studies that reported the incidence of hypospadias or other congenital malformations in offspring of women who did or did not use loratadine during pregnancy. Together the studies in our meta-analysis provided information about 453 053 male births in Brazil, Canada, Denmark, Israel, Italy, Sweden, the UK and the US.

Notes

Acknowledgements

This study was funded by grant K23 HD051585-01 from the National Institute of Child Health and Human Development (NICHD). The NICHD was not involved in study design; the collection, analysis and interpretation of data; or the writing of this report. We thank reference librarian Melissa Ratajeski for her guidance. No authors have any conflicts of interest to report.

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Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • Eleanor B. Schwarz
    • 1
  • Myla E. Moretti
    • 2
  • Smita Nayak
    • 1
  • Gideon Koren
    • 2
  1. 1.Division of General Internal Medicine, Department of Medicine, Center for Research on Health CareUniversity of PittsburghPittsburghUSA
  2. 2.Motherisk Program, Division of Clinical Pharmacology/ToxicologyHospital for Sick ChildrenTorontoCanada

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