Rising cases of drug‐induced pulmonary fibrosis: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database, 2000–2022

Purpose Pulmonary fibrosis (PF) is a severe, progressive disease, which may be caused by exposure to certain medications. Methods We queried the U.S. FDA Adverse Event Reporting System (FAERS) from 2000 to 2022, using the search terms “pulmonary fibrosis” and “idiopathic pulmonary fibrosis” and excl...

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Bibliographic Details
Published in:	Pharmacoepidemiology and drug safety Vol. 33; no. 5; pp. e5797 - n/a
Main Authors:	McCall, Kenneth L., Hennig, Kelsey R., Abe, Zachary T., Dattler, Danielle N., Hurd, Karyssa L., Portnoy, Sophie L., Zagoria, Zoey J.
Format:	Journal Article
Language:	English
Published:	Chichester, UK John Wiley & Sons, Inc 01-05-2024 Wiley Subscription Services, Inc
Subjects:	Adolescent Adult Adverse Drug Reaction Reporting Systems - statistics & numerical data Adverse events Aged antineoplastic drug Antineoplastic drugs antirheumatic drug Corticosteroids Databases, Factual - statistics & numerical data Drug-Related Side Effects and Adverse Reactions - epidemiology Female Fibrosis Humans idiopathic pulmonary fibrosis Immunosuppressive agents interstitial lung disease Lung diseases Male Middle Aged Pharmacovigilance Pulmonary fibrosis Pulmonary Fibrosis - chemically induced Pulmonary Fibrosis - epidemiology United States - epidemiology United States Food and Drug Administration United States idiopathic pulmonary fibrosis pharmacovigilance interstitial lung disease antineoplastic drug pulmonary fibrosis antirheumatic drug
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Summary:	Purpose Pulmonary fibrosis (PF) is a severe, progressive disease, which may be caused by exposure to certain medications. Methods We queried the U.S. FDA Adverse Event Reporting System (FAERS) from 2000 to 2022, using the search terms “pulmonary fibrosis” and “idiopathic pulmonary fibrosis” and excluded reports with patients under the age of 18 years, and patients with unknown sex or age. Reports were sorted by generic drug names, counted, and plotted over time using a best‐fit trendline based on an exponential function. Results From 2000 to 2022, there were 24 095 935 adverse drug events reported in FAERS, of which 17 520 (0.07%) were reported as PF. After excluding reports containing patients with unknown age (5255, 30%), sex (122, 0.7%), and age below 18 years old (155, 0.9%), our study included 11 988 reports. The mean age of the study sample was 66.5 ± 13.1 years, and 6248 patients (52.1%) were male. Plotting the 11 988 reports by year revealed an exponential best fit line (R2 = 0.88) with a positive slope over time. The top five drug classes associated with PF were disease modifying antirheumatic drugs (DMARDs, 39.4%), antineoplastic agents (26.4%), cardiovascular agents (12.6%), corticosteroids (4.6%), and immunosuppressive agents (4.0%). Conclusion A 23‐year analysis of the FAERS database revealed exponentially increasing adverse event reports of PF. Significant annual increases in reporting of PF suspected with DMARDs and antineoplastic agents were identified. Our study highlights important trends, which should be used to guide PF research related to drugs of potential importance.
Bibliography:	The study was approved by the Binghamton University Institutional Review Board. IRB ID# STUDY00004072 February 3, 2023. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1053-8569 1099-1557 1099-1557
DOI:	10.1002/pds.5797