Document Detail

Angiotensin-II receptor 1 antagonist fetopathy--risk assessment, critical time period and vena cava thrombosis as a possible new feature.
MedLine Citation:
PMID:  22816796     Owner:  NLM     Status:  MEDLINE    
AIMS: Angiotensin-II receptor 1 antagonists (AT₁-antagonists) may cause severe and even lethal fetopathy in late pregnancy. However, exposure still occurs in spite of warnings in package leaflets. This study aimed to assess the risk of fetopathy, the sensitive time window, and possible new symptoms in prospective as well as retrospective cases with AT₁-antagonist treatment during the second or third trimester of pregnancy.
METHODS: Patients were enrolled by the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy between 1999 and 2011 through risk consultation. Symptoms defined as indicative of AT₁-antagonist fetopathy were: oligo-/anhydramnios, renal insufficiency, lung hypoplasia, joint contractures, skull hypoplasia and fetal/neonatal death.
RESULTS: In 5/29 (17%) prospectively enrolled cases with AT₁-antagonist exposure beyond the first trimester oligo-/anhydramnios was diagnosed. Two infants showed additional symptoms of fetopathy. The risk is more than 30% if treatment continues beyond the 20th week of pregnancy. Oligo-/anhydramnios was reversible after AT₁-antagonist withdrawal. Among 16 retrospective case reports, three infants presented with a thrombosis of the inferior vena cava in the vicinity of the renal veins. Four out of 13 live births did not survive.
CONCLUSIONS: Our survey suggests that the risk increases with duration of AT₁-antagonist treatment into late pregnancy and oligo-/anhydramnios may be reversible after AT₁-antagonist discontinuation. Thrombosis of inferior vena cava may be a new feature of AT₁-antagonist fetopathy. AT₁-antagonist medication during pregnancy constitutes a considerable risk and must be discontinued immediately. In case of indicative diagnostic findings in either the fetus or newborn, previous maternal AT₁-antagonist exposure should be considered.
Marc Oppermann; Stephanie Padberg; Angela Kayser; Corinna Weber-Schoendorfer; Christof Schaefer
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  75     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-06     Completed Date:  2013-08-06     Revised Date:  2014-03-09    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  822-30     Citation Subset:  IM    
Copyright Information:
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.
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MeSH Terms
Abnormalities, Drug-Induced / diagnosis,  etiology*
Angiotensin II Type 1 Receptor Blockers / adverse effects*
Fetal Death
Infant, Newborn
Maternal Age
Oligohydramnios / chemically induced
Pregnancy Complications, Cardiovascular / chemically induced*
Pregnancy Trimester, Third
Prospective Studies
Retrospective Studies
Risk Assessment
Time Factors
Vena Cava, Inferior / drug effects*,  pathology
Venous Thrombosis / chemically induced*,  diagnosis
Young Adult
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers

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

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