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Statins and Interstitial Lung Disease

A Systematic Review of the Literature and of Food and Drug Administration Adverse Event Reports

*From the Section of Cardiovascular Medicine (Dr. Fernández), Yale University School of Medicine, New Haven, CT; Division of Cardiology (Dr. Karas), Institute for Clinical Research and Health Policy Studies (Dr. Alsheikh-Ali), Tufts Medical Center, Tufts University School of Medicine, Boston, MA; and Division of Cardiology (Dr. Thompson), The Henry Low Heart Center, Hartford Hospital, Hartford, CT.

Correspondence to: Paul D. Thompson, MD, Cardiology Division, Hartford Hospital, 80 Seymour St, Hartford, CT 06102; e-mail: pthomps{at}harthosp.org

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.

Key Words: drug-induced interstitial lung disease • hydroxymethylglutaryl coenzyme A reductase inhibitors • interstitial pneumonitis • parenchymal lung disease • pulmonary fibrosis • statins

Abbreviations: FDA-AER, Food and Drug Administration adverse event reporting • HMG-CoA, hydroxymethylglutaryl coenzyme A • ILD, interstitial lung disease