Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports.
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.
Fernández
Antonio B
AB
Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.
Karas
Richard H
RH
Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.
Alsheikh-Ali
Alawi A
AA
Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.
Thompson
Paul D
PD
Division of Cardiology, The Henry Low Heart Center, Hartford Hospital, Hartford, CT. Electronic address: pthomps@harthosp.org.
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
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors