Key result
Amiodarone exposure was associated with 4,896 cases of pulmonary adverse events and 56 detected signals, including 21 new and unexpected signals.
Why the study?
Amiodarone carries a risk of pulmonary toxicity, but large descriptive case series examining amiodarone-induced pulmonary toxicity were lacking.
What are the characteristics and signals of amiodarone-related pulmonary adverse events in a real-world pharmacovigilance database?
Observational (n=4,896)
What are the characteristics and signals of amiodarone-related pulmonary adverse events in a real-world pharmacovigilance database?
This large pharmacovigilance study identifies 56 signals of amiodarone-induced pulmonary toxicity, including 21 new and unexpected signals, highlighting the need for ongoing clinical vigilance.
Answers are grounded in this paper and cite their sources.
Amiodarone pulmonary signals, including 21 new ones, warrant vigilance in monitoring; leaves open need for prospective confirmation.
BACKGROUND: Amiodarone is used to treat cardiac arrhythmias but carries a risk of pulmonary toxicity. Despite this well-known side effect, there is currently no large descriptive case series studying amiodarone-induced pulmonary toxicity. METHODS: The reporting odds ratio (ROR) was utilized to quantify signals of amiodarone-related pulmonary adverse events (AEs) from 2004 to 2023. Severity comparisons between serious and non-serious cases were conducted using the Mann-Whitney U test or chi-square (χ2) test, and signal prioritization was achieved through rating scales. RESULTS: A total of 4896 cases of amiodarone-related pulmonary AEs were found, and 56 signals were detected. 27 AEs were classified as serious adverse reactions, and 21 AEs were identified as new and unexpected signals. Even when stratified by age, weight, sex, and reporter type, the association between amiodarone and pulmonary diseases persisted. Seven strong clinical priority signals were defined. The median time to onset (TTO) for strong, moderate, and weak clinical priority signals was 221, 126, and 227 days, respectively. All disproportional signals exhibited an early failure-type pattern. CONCLUSION: Our study offers a deeper and broader understanding of the pulmonary safety profile of amiodarone, which will aid healthcare professionals in mitigating the risk of pulmonary adverse events in clinical practice.
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Yang et al. (2024) conducted an observational in cardiac arrhythmias (n=4,896). Amiodarone was evaluated on signals of amiodarone-related pulmonary adverse events. Amiodarone exposure was associated with 4,896 cases of pulmonary adverse events and 56 detected signals, including 21 new and unexpected signals.
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