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Statins and Interstitial Lung Disease: A Systematic Review of the Literature and of Food and Drug Administration Adverse Event Reports

Antonio B. Fernández, MD; Richard H. Karas, MD, PhD; Alawi A. Alsheikh-Ali, MD; Paul D. Thompson, MD
Author and Funding Information

*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@harthosp.org

Dr. Thompson has received grant/research support from Merck, Pfizer, AstraZeneca, and B. Braun; is a consultant for Astra- Zeneca and Merck; is on the Speaker's Bureau for Merck, Pfizer, Abbott, AstraZeneca, and ScheringPlough; and owns stock in Schering Plough, Merck, Illumina, and Zoll. He has other financial or occasional speaking honoraria from Merck, Pfizer, Abbott, AstraZeneca, ScheringPlough, and Reliant. Dr. Karas is a consultant for Merck and Abbott, and has received honoraria from Merck and Abbott. Dr. Alsheikh-Ali is recipient of a faculty development award from Pfizer and Tufts Medical Center. Dr. Fernandez has no conflicts of interests to disclose.


Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2008;134(4):824-830. doi:10.1378/chest.08-0943
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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.


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