title: Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports.
abstract: 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).
  
  
  METHODS
  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.
  
  
  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.
authors.affiliation: Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.
authors.forename: Antonio B
authors.initials: AB
authors.lastname: Fernández
authors.affiliation: Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.
authors.forename: Richard H
authors.initials: RH
authors.lastname: Karas
authors.affiliation: Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.
authors.forename: Alawi A
authors.initials: AA
authors.lastname: Alsheikh-Ali
authors.affiliation: Division of Cardiology, The Henry Low Heart Center, Hartford Hospital, Hartford, CT. Electronic address: pthomps@harthosp.org.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Thompson
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D006949:Hyperlipidemias / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D017563:Lung Diseases, Interstitial / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors