| アブストラクト | BACKGROUND: Drug-induced interstitial lung disease (DI-ILD) is a heterogeneous subgroup of interstitial lung diseases (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 1st January 1985 to 1st April 2022 which had ADR coded in MedDRA with a High Level Group Term "Lower respiratory tract disorders (excluding obstruction and infection)" involving patients aged 18 and over. RESULTS: We analysed 7234 cases involving 13 059 suspect medications and 1112 specific molecules. Cases were categorised as serious in 96.7% and in 13.3% death ensued. Men accounted for 54.4% of the cases. Median age was 69 [18-103] years. The most prevalent ADRs were "ILD" (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 it properly and discontinue the culprit drug urgently. |
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| 投稿者 | Yavordios, Sophie; Beltramo, Guillaume; Freppel, Romane; Salinas, Frederique Beau; 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, Centre Hospitalier Universitaire Dijon-Bourgogne,;Dijon, France.;INSERM U1231, Labex LIPSTIC and label of excellence from la Ligue Nationale;contre le Cancer.;University of Burgundy, Faculty of Medicine and Pharmacy, Dijon, France.;Regional Pharmacovigilance Center, Francois Mitterrand Hospital, University of;Burgundy Franche-Comte, Dijon, France.;Regional Pharmacovigilance Center of Centre Val de Loire, Department of;Pharmacosurveillance, University Hospital of Tours, France.;Regional Pharmacovigilance center, Hopital Europeen Georges Pompidou, AP-HP,;Centre - Universite Paris Cite, Paris, France.;Paris Cite University, Innovative Therapies in Haemostasis, INSERM, Paris,;France.;Pharmacology Department, APHP, GHU Sorbonne Univeristy, Regional;Pharmacovigilance Center Pitie-Saint Antoine, Paris, France.;contributed equally to this work.;Dijon, France philippe.bonniaud@chu-dijon.fr. |
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