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Observational Study
. 2025 Feb 6;65(2):2400756.
doi: 10.1183/13993003.00756-2024. Print 2025 Feb.

Diffuse lung diseases ascribed to drugs: a nationwide observational study over 37 years using the French Pharmacovigilance Database

Sophie Yavordios  1 , Guillaume Beltramo  1   2   3 , Romane Freppel  4 , Frédérique Beau Salinas  5 , Christine Le Beller  6   7 , Kevin Bihan  8 , Pierre Mouillot  1 , Marjolaine Georges  1   3 , Aurélie Grandvuillemin  4   9 , Philippe Bonniaud  10   2   3   9
Affiliations
Observational Study

Diffuse lung diseases ascribed to drugs: a nationwide observational study over 37 years using the French Pharmacovigilance Database

Sophie Yavordios et al. Eur Respir J. .

Abstract

Background: Drug-induced interstitial lung disease (DI-ILD) is a heterogeneous subgroup of interstitial lung disease (ILD). The number of molecules involved is increasing with time. Due to their low incidence, DI-ILDs may be detected only after a drug has been marketed, notably through adverse drug reaction (ADR) reports to pharmacovigilance centres. The aim of our study was to describe drug-induced diffuse lung disease cases notified to and recorded by the French Pharmacovigilance Database (FPVD), reported clinical pictures and the potentially causal drugs.

Methods: This retrospective study included cases registered in the FPVD from 1 January 1985 to 1 April 2022 which had ADRs coded in MedDRA with a High-Level Group Term "Lower respiratory tract disorders (excluding obstruction and infection)" involving patients aged ≥18 years.

Results: We analysed 7234 cases involving 13 059 suspect medications and 1112 specific molecules. Cases were categorised as serious in 96.7% and death ensued in 13.3%. Males accounted for 54.4% of the cases. Median (range) age was 69 (18-103) years. The most prevalent ADRs were "Interstitial lung disease" (51.0%), "Pulmonary oedema" (acute/non-acute) (15.6%) and "Pulmonary fibrosis" (10.5%). Anti-cancer drugs (31.2%) and cardiovascular drugs (29.1%) were the most prominent therapeutic classes involved, with amiodarone being the most commonly reported suspected drug (10.0%), followed by methotrexate (3.1%).

Conclusion: This study from a large nationwide dataset spanning 37 years is the largest known to date. Drug-induced diffuse lung diseases are serious with a potentially fatal outcome. Accurate diagnoses remain essential to identify the diseases properly and discontinue the culprit drug urgently.

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Conflict of interest statement

Conflict of interest: S. Yavordios reports support for attending meetings from ADENE. G. Beltramo reports payment or honoraria for lectures, presentations, manuscript writing or educational events from Boehringer Ingelheim, support for attending meetings from Boehringer Ingelheim and Roche, participation on a data safety monitoring board or advisory board with Boehringer Ingelheim, and receipt of equipment, materials, drugs, medical writing, gifts or other services from AstraZeneca. C. Le Beller reports payment or honoraria for lectures, presentations, manuscript writing or educational events from Viatris Santé. K. Bihan reports participation on a data safety monitoring board or advisory board with ANRS CO24 OncoVIHAC cohort and SONOFIRST, stock (or stock options) with MEDINSPIRE (SAS), and the following financial (or non-financial) interests: patent co-inventor (WO2023166025). M. Georges reports payment for expert testimony from Effik, RedMed and Oxyvie, and support for attending meetings from Asten. P. Bonniaud reports grants from AstraZeneca, payment or honoraria for lectures, presentations, manuscript writing or educational events from Sanofi, AstraZeneca and GlaxoSmithKline, support for attending meetings from AstraZeneca, Novartis, Sanofi, GlaxoSmithKline, Stallergene and Boehringer Ingelheim, and participation on a data safety monitoring board or advisory board with AstraZeneca, Novartis, Sanofi, GlaxoSmithKline and Boehringer Ingelheim. The remaining authors have nothing to disclose.

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