Key result
Azacitidine is linked to ~400% higher reporting odds of pericarditis.
Why the study?
Drug-induced pericarditis is an important cause of pericarditis that can lead to serious complications if unnoticed, and the association with azacitidine had not been clearly established.
Does azacitidine use increase the risk of pericarditis?
Observational (n=48)
Does azacitidine use increase the risk of pericarditis?
Odds Ratio: 5
A significant safety signal exists between azacitidine use and pericarditis, suggesting clinicians should monitor for this adverse event and consider discontinuation if suspected.
May warrant monitoring for pericarditis with azacitidine; leaves open causality and need for prospective validation before practice change.
BACKGROUND: Drug-induced pericarditis is an important cause of pericarditis and if unnoticed and unmanaged can lead to constrictive pericarditis, pericardial effusion, and cardiac tamponade. OBJECTIVE: The objective of this analysis was to determine if a significant signal exists between azacitidine use and pericarditis. METHODS: A pharmacovigilance analysis was performed using the FDA Adverse Event Database. RESULTS: 48 reports of azacitidine-induced pericarditis with azacitidine as the suspect drug were identified. The most common indications for azacitidine use in the adverse event reports were myelodysplastic syndrome (48%) and acute myelogenous leukemia (27%). Physicians reported 44% of the azacitidine-induced pericarditis reports, while other health professional reported 52% of the reports. The disproportionality analysis showed a proportional reporting ratio of 5.0, χ2 of 149.8, reporting odds ratio of 5.0, and IC025 of 1.8. Literature review found 3 case reports of azacitidine-induced pericarditis. CONCLUSION: The signal between azacitidine and pericarditis was found to be statistically significant. Clinicians should be aware of the possible risk of pericarditis when prescribing azacitidine. If there is suspicion for azacitidine-induced pericarditis, clinicians should consider discontinuation of azacitidine to improve patient's symptoms and reduce the likelihood of the development of constrictive pericarditis, pericardial effusion, and cardiac tamponade.
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Chu et al. (2022) conducted an observational in Pericarditis (n=48). Azacitidine was evaluated on Azacitidine-induced pericarditis signal (ROR 5.0). Azacitidine use was associated with a statistically significant safety signal for pericarditis in the FDA Adverse Event Database, demonstrating a reporting odds ratio of 5.0.
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