Document Detail

Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services.
MedLine Citation:
PMID:  15749258     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Published data on pregnancy outcome after exposure to H2-blockers is scarce. The aim of the present study was to evaluate the data collected by the memberships of the European Network of Teratology Information Services (ENTIS). METHODS: The patients were pregnant women who or whose doctor or midwife did contact a Teratology Information Service for risk assessment after the use of a H2-blocker in pregnancy. The data were prospectively collected, i.e. before the outcome of pregnancy was known. Standardized procedures for data collection were used by each centre. The data of the exposed women were compared to those of a control group exposed to non-teratogenic substances. RESULTS: Data on the outcome of 553 pregnancies with exposure to an H2-blocker were evaluated (ranitidine n=335; cimetidine n=113, famotidine n=75; nizatidine n=15, roxatidine n=15). Most of them had been exposed at least in the first trimester. The incidence of premature deliveries was higher in the exposed group compared to the control group. There was no increase in the incidence of major malformations. Two pregnancies with maternal use of famotidine in early pregnancy were terminated after the prenatal diagnosis of a neural tube defect. CONCLUSION: There is no indication for an increased risk of major malformations after the use of H2-blockers during pregnancy.
Hanneke Garbis; Elisabeth Elefant; Orna Diav-Citrin; Pierpaolo Mastroiacovo; Christof Schaefer; Thierry Vial; Maurizio Clementi; Electra Valti; Patricia McElhatton; Carlo Smorlesi; Elvira Pinilla Rodriguez; Elisabeth Robert-Gnansia; Paul Merlob; Gertrud Peiker; Tomas Pexieder; Lavinia Schueler; Annukka Ritvanen; Monique Mathieu-Nolf
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Reproductive toxicology (Elmsford, N.Y.)     Volume:  19     ISSN:  0890-6238     ISO Abbreviation:  Reprod. Toxicol.     Publication Date:    2005 Mar-Apr
Date Detail:
Created Date:  2005-03-07     Completed Date:  2005-07-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8803591     Medline TA:  Reprod Toxicol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  453-8     Citation Subset:  IM    
Teratology Information Service, National Institute of Public Health and Environment, P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
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MeSH Terms
Abnormalities, Drug-Induced / epidemiology,  etiology*
Case-Control Studies
Europe / epidemiology
Follow-Up Studies
Gestational Age
Histamine H2 Antagonists / adverse effects*
Infant, Newborn
International Cooperation
Pregnancy Outcome* / epidemiology
Prenatal Exposure Delayed Effects*
Prospective Studies
Ranitidine / adverse effects*
Risk Assessment
Reg. No./Substance:
0/Histamine H2 Antagonists; 66357-35-5/Ranitidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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