Author ORCID Identifier

Kenneth L. McCall: http://orcid.org/0000-0003-2061-108X

Document Type

Article

Publication Date

4-29-2024

Keywords

Antineoplastic drug ; Antirheumatic drug ; Idiopathic pulmonary fibrosis ; Interstitial lung disease ; Pharmacovigilance ; Pulmonary fibrosis

Abstract

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.

Comments

https://doi.org/10.1002/pds.5797

Publisher Attribution

© 2024 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Creative Commons License

Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

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