Drug-Induced Pulmonary Fibrosis: National Database Analysis

Area of Science:

• Pharmacovigilance and Drug Safety
• Pulmonary Medicine
• Oncology and Immunology

Background:

• Pulmonary fibrosis (PF) is characterized by progressive lung scarring and functional decline.
• Medications are a significant and common cause of drug-induced pulmonary fibrosis.
• Understanding the specific drugs associated with PF is crucial for patient safety.

Purpose of the Study:

• To investigate the drug etiological structure of pulmonary fibrosis.
• To analyze spontaneous reports of PF in the Russian National Pharmacovigilance database.
• To identify leading drug classes and specific agents implicated in PF development.

Main Methods:

• Retrospective, descriptive pharmacoepidemiologic study.
• Analysis of spontaneous reports (SRs) of PF from January 2019 to May 2024.
• Data sourced from the Russian National Pharmacovigilance database.

Main Results:

• 1308 SRs on PF were identified; 30.7% of patients experienced fatal outcomes.
• Antineoplastic and immunomodulating agents were the most frequently reported drug class (51.9%).
• Top implicated drugs included rituximab, methotrexate, and etanercept; annual SRs nearly doubled from 2021-2023.

Conclusions:

• A significant increase in PF reporting was observed in the Russian pharmacovigilance database (2019-2024).
• Antineoplastic and immunomodulating agents play a prominent role in the development of drug-induced PF.
• Findings highlight the need for vigilance regarding these drug classes in PF surveillance.