Kamath Ashwin
Department of Pharmacology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Sci Rep. 2025 Jan 9;15(1):1455. doi: 10.1038/s41598-025-85681-0.
Drug-induced eosinophilic pneumonia (EP) is an uncommon adverse drug reaction. Many drugs have been reported to cause EP, the evidence mainly being in the form of case reports/case series. This study aims to conduct an exploratory analysis of the United States Food and Drug Administration adverse event reporting system (FAERS) database to identify previously unknown drugs that can cause EP and supplement the available evidence for known culprit drugs. A retrospective case-noncase study was conducted using individual case safety reports (ICSRs) reported to the US FAERS from the first quarter of 2004 to the second quarter of 2024. Cases of potentially drug-induced EP were identified using OpenVigil application by conducting a narrow and broad scope search using the Medical Dictionary of Regulatory Activities preferred terms. A base list of drugs described in select literature to have caused EP was used to categorize known and unknown drugs. A disproportionality analysis was performed, with a reporting odds ratio > 2, lower end of the 95% confidence interval > 1, and a minimum of 3 reported cases considered a signal of disproportionate reporting (SDR). During the study period, 8,702,548 individual case safety reports (ICSRs) were submitted to the FAERS. Of these, 855 ICSRs using the narrow scope search and 1411 ICSRs using the broad scope search reported EP. The three most commonly reported drugs with an SDR for EP using the narrow scope search were daptomycin, naltrexone, and prednisone. The most common indications for the use of the drugs were infections, immunological conditions, asthma, and central nervous system disorders. In total, there were 45 drugs with an SDR but no supporting literature evidence available. The number of drugs implicated in causing EP has increased over the years. Several antimicrobial agents, followed by drugs affecting the central nervous system and anticancer drugs, including monoclonal antibodies, can produce EP. The list of suspected drugs identified in this study, especially those with SDR and literature evidence, should be strongly considered as a possible cause in patients presenting with pneumonia not explained otherwise.
药物性嗜酸性粒细胞性肺炎（EP）是一种罕见的药物不良反应。许多药物已被报道可导致EP，证据主要为病例报告/病例系列形式。本研究旨在对美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行探索性分析，以识别此前未知的可导致EP的药物，并补充已知致病药物的现有证据。使用2004年第一季度至2024年第二季度向美国FAERS报告的个体病例安全报告（ICSR）进行回顾性病例对照研究。通过使用《监管活动医学词典》首选术语进行狭义和广义范围搜索，利用OpenVigil应用程序识别潜在的药物性EP病例。使用选定文献中描述的已导致EP的药物基础列表对已知和未知药物进行分类。进行了不成比例分析，报告比值比>2、95%置信区间下限>1且至少有3例报告病例被视为不成比例报告信号（SDR）。在研究期间，共向FAERS提交了8702548份个体病例安全报告。其中，狭义范围搜索的855份ICSR和广义范围搜索的1411份ICSR报告了EP。狭义范围搜索中报告有EP的SDR的三种最常见药物是达托霉素、纳曲酮和泼尼松。这些药物最常见的使用适应症为感染、免疫性疾病、哮喘和中枢神经系统疾病。总共有45种药物有SDR但无支持性文献证据。多年来，涉及导致EP的药物数量有所增加。几种抗菌药物，其次是影响中枢神经系统的药物和抗癌药物，包括单克隆抗体，均可导致EP。本研究中确定的疑似药物清单，尤其是那些有SDR和文献证据的药物，在出现无法解释的肺炎患者中应被强烈视为可能的病因。
