Safety Signal between Azacitidine and Pericarditis

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Article / Publication Details Abstract

Background: Drug-induced pericarditis is an important cause of pericarditis and if un-noticed and un-managed 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 PRR of 5.0, chi-squared of 149.8, ROR of 5.0 and IC025 of 1.8. Literature review found three 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.

S. Karger AG, Basel

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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