| アブストラクト | 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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| 投稿者 | Yavordios, Sophie; Beltramo, Guillaume; Freppel, Romane; Beau Salinas, Frederique; Le Beller, Christine; Bihan, Kevin; Mouillot, Pierre; Georges, Marjolaine; Grandvuillemin, Aurelie; Bonniaud, Philippe |
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| 組織名 | Service de Pneumologie et Soins Intensifs Respiratoires, Centre de Reference;Constitutif des Maladies Pulmonaires Rares de l'Adultes de Dijon, Reseau;OrphaLung, Filiere RespiFil, CHU Dijon-Bourgogne, Dijon, France.;INSERM U1231, Labex LIPSTIC and label of excellence from La Ligue Nationale;Contre le Cancer, Dijon, France.;Faculty of Medicine and Pharmacy, University of Burgundy, Dijon, France.;Regional Pharmacovigilance Centre, Francois Mitterrand Hospital, University of;Burgundy Franche-Comte, Dijon, France.;Regional Pharmacovigilance Centre of Centre Val de Loire, Department of;Pharmacosurveillance, University Hospital of Tours, Tours, France.;Regional Pharmacovigilance Centre, Hopital Europeen Georges Pompidou, AP-HP,;Centre - Universite Paris Cite, Paris, France.;Paris Cite University, Innovative Therapies in Haemostasis, INSERM, Paris,;France.;Pharmacology Department, AP-HP, GHU Sorbonne University, Regional;Pharmacovigilance Centre Pitie-Saint Antoine, Paris, France.;A. Grandvuillemin and P. Bonniaud contributed equally to this work.;OrphaLung, Filiere RespiFil, CHU Dijon-Bourgogne, Dijon, France;philippe.bonniaud@chu-dijon.fr. |
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