Document Detail


Gynaecomastia associated with proton pump inhibitors: a case series from the Spanish Pharmacovigilance System.
MedLine Citation:
PMID:  17536878     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Proton pump inhibitors (PPIs) are widely used in the management of peptic ulcer and related symptoms. They have been linked to certain endocrine adverse reactions, including gynaecomastia. The aim of the present study is to investigate the association between the use of PPIs and the development of gynaecomastia. METHODS: Reports of cases of gynaecomastia that had putatively been induced by PPIs and that had been collected by the Spanish Pharmacovigilance System via the 'yellow card' scheme, were analysed. Reporting odds ratios (RORs) were calculated as a measure of disproportionality. RESULTS: Twenty-four cases of gynaecomastia associated with PPIs were identified in the database of the Spanish Pharmacovigilance System. Overall, there was a clear temporal sequence of events in all cases and the adverse effect disappeared after drug withdrawal in most of the cases; 14 patients were also receiving other drugs at the time of the adverse effect. The ROR for omeprazole exposure versus no exposure, but not that for other PPIs, showed a statistically significant elevation (ROR adjusted for age 5.23; 95% CI 3.32, 8.26). CONCLUSION: Considering the widespread use of PPIs, gynaecomastia may affect a large number of patients. In most cases, the condition seems to be reversible with drug withdrawal. Doctors should be aware of this potential adverse reaction when prescribing PPIs to their patients over long periods of time.
Authors:
Alfonso Carvajal; Diego Macias; Angélica Gutiérrez; Sara Ortega; María Sáinz; Luis H Martín Arias; Alfonso Velasco
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Drug safety : an international journal of medical toxicology and drug experience     Volume:  30     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2007  
Date Detail:
Created Date:  2007-05-31     Completed Date:  2007-08-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  527-31     Citation Subset:  IM    
Affiliation:
Instituto de Farmacoepidemiología, Universidad de Valladolid, Valladolid, Spain. carvajal@ife.uva.es
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MeSH Terms
Descriptor/Qualifier:
Adult
Adverse Drug Reaction Reporting Systems
Aged
Aged, 80 and over
Anti-Ulcer Agents / adverse effects*
Databases, Factual
Gynecomastia / chemically induced*
Humans
Male
Middle Aged
Odds Ratio
Omeprazole / adverse effects
Proton Pumps / antagonists & inhibitors*
Retrospective Studies
Spain
Chemical
Reg. No./Substance:
0/Anti-Ulcer Agents; 0/Proton Pumps; 73590-58-6/Omeprazole

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


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