ArticlePloS one2025
A real-world pharmacovigilance analysis of ALK inhibitor-associated pleural and pericardial effusion using the FDA Adverse Events Reporting System (FAERS) database from 2013 to 2024.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionThe advent of anaplastic lymphoma kinase (ALK) inhibitors has revolutionized the treatment of ALK-rearranged malignancies, establishing these agents as vital components of precision oncology. Despite their proven efficacy in prolonging progression-free and overall survival, ALK inhibitors are associated with notable adverse events, particularly cardiopulmonary complications such as pleural and pericardial effusions.
methodsThis study investigates the real-world prevalence and risk of these effusions associated with five ALK inhibitors, crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib, through disproportionality analysis using the FAERS pharmacovigilance database.
resultsThe data revealed elevated reporting odds ratios (RORs) for pleural and pericardial effusions, with notable variability among the agents. Crizotinib exhibited RORs of 7.76 (95% CI: 6.60-9.12) and 9.00 (95% CI: 7.10-11.41) for pleural and pericardial effusions, respectively. Ceritinib demonstrated RORs of 7.36 (95% CI: 5.16-10.50) and 10.80 (95% CI: 6.79-17.19), respectively. Alectinib showed lower RORs of 4.76 (95% CI: 3.80-5.97) and 6.67 (95% CI: 4.92-9.04). Brigatinib displayed elevated RORs of 8.70 (95% CI: 6.58-11.52) and 7.87 (95% CI: 4.95-12.51). Lorlatinib presented the highest risk, with RORs of 8.61 (95% CI: 6.72-11.02) and 12.57 (95% CI: 9.08-17.38).
conclusionsThis study highlights the critical need for vigilant pharmacovigilance and a multidisciplinary approach to balance the oncologic benefits of ALK inhibitors against their cardiopulmonary risks. By enhancing awareness and fostering proactive management, these findings aim to support the safe and effective use of ALK inhibitors in treating ALK-rearranged malignancies.
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