| アブストラクト | Introduction Calcium channel blockers (CCBs), particularly amlodipine, are among the most widely prescribed antihypertensive agents globally. However, no comprehensive disproportionality analysis has quantified this association. This pharmacovigilance study utilized the FDA Adverse Event Reporting System (FAERS) to evaluate the reporting association between CCBs and pseudolymphoma. Methods The FAERS database was parsed through its 14,104,743 adverse event reports. Five CCBs were evaluated: three dihydropyridines (amlodipine, nifedipine, felodipine) and two non-dihydropyridines (diltiazem, verapamil). Disproportionality was quantified using reporting odds ratios. The MedDRA preferred term "pseudolymphoma" was employed for case identification. Results Among 319 pseudolymphoma reports, 44 were associated with dihydropyridines and 1 with non-dihydropyridines. Amlodipine demonstrated the strongest signal (ROR 38.08, 95% CI 27.60-52.54; n=42), followed by nifedipine (ROR 18.61, 95% CI 4.64-74.74; n=2). Diltiazem showed a non-significant signal (ROR 5.47, 95% CI 0.77-38.93; n=1). Felodipine and verapamil yielded no reports. Dihydropyridines exhibited 7- to 70-fold greater reporting odds ratios compared with non-dihydropyridines. Conclusions This analysis establishes a robust, though not causal, class-specific safety signal linking dihydropyridine CCBs, particularly amlodipine, to pseudolymphoma risk. The substantial disproportionality suggests a pharmacologically mediated mechanism requiring heightened clinical surveillance, prompt recognition, and timely drug discontinuation to prevent potential malignant transformation. |
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