Document Detail

Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports.
MedLine Citation:
PMID:  18689579     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To systematically review all published case reports and the US Food and Drug Administration adverse event reporting (FDA-AER) database to examine the relationship between statins and interstitial lung disease (ILD). DATA SOURCES: PubMed (1987 to September 2007) and the FDA-AER database (as of June 2007) were searched for reports of ILD in which a statin was listed as a causative suspect. REVIEW METHODS: Two authors (one author for Pub Med cases and one for FDA-AER cases) independently abstracted patient data. Given the paucity of information, all case reports and case series in English and French were included. All adverse event reports from the FDA-AER database in which a statin was listed as causative suspect were included. RESULTS: The literature search using PubMed yielded eight articles describing a total of 14 case reports of ILD in association with statin use. The FDA-AER system database contained 162 cases of reported statin-induced ILD as of June 2007. For every 10,000 reports of a statin-associated adverse event, approximately 1 to 40 reports were for ILD. CONCLUSIONS: Statin-induced ILD is a possible newly recognized side effect of statin therapy. The mechanism of lung injury is not defined. The current review provides novel information from the FDA-AER that supports a possible, although unusual, pulmonary class effect of statins.
Antonio B Fernández; Richard H Karas; Alawi A Alsheikh-Ali; Paul D Thompson
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2008-08-08
Journal Detail:
Title:  Chest     Volume:  134     ISSN:  0012-3692     ISO Abbreviation:  Chest     Publication Date:  2008 Oct 
Date Detail:
Created Date:  2008-10-09     Completed Date:  2008-11-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0231335     Medline TA:  Chest     Country:  United States    
Other Details:
Languages:  eng     Pagination:  824-30     Citation Subset:  AIM; IM    
Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT, USA.
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MeSH Terms
Adverse Drug Reaction Reporting Systems*
Aged, 80 and over
Databases, Factual
Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
Hyperlipidemias / complications,  drug therapy,  epidemiology
Lung Diseases, Interstitial / chemically induced*,  diagnosis,  epidemiology*
Middle Aged
Risk Factors
United States / epidemiology
United States Food and Drug Administration
Reg. No./Substance:
0/Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

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