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Pharmacoepidemiol Drug Saf ; 33(5): e5797, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38680101

RESUMEN

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.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Bases de Datos Factuales , Fibrosis Pulmonar , United States Food and Drug Administration , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Estados Unidos/epidemiología , Bases de Datos Factuales/estadística & datos numéricos , Masculino , Fibrosis Pulmonar/epidemiología , Fibrosis Pulmonar/inducido químicamente , Femenino , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Persona de Mediana Edad , Anciano , Adulto , Adolescente , Farmacovigilancia
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