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Updated: Aug 31, 2025

Sterile Pericarditis in Aachener Minipigs As a Model for Atrial Myopathy and Atrial Fibrillation
Published on: September 24, 2021
Safety Signal between Azacitidine and Pericarditis
Brandon Chu1, Ajit Venkatakrishnan2, Pushkar Aggarwal3
1University of Maryland, College Park, Maryland, USA.
A significant link between azacitidine and pericarditis was identified. Healthcare providers should monitor for pericarditis in patients taking azacitidine to prevent serious cardiac complications.
Area of Science:
- Pharmacovigilance
- Clinical Oncology
- Cardiology
Background:
- Drug-induced pericarditis is a serious condition that can lead to severe cardiac issues if not managed.
- Azacitidine is a medication used for myelodysplastic syndrome and acute myelogenous leukemia.
Discussion:
- This study analyzed the FDA Adverse Event Database to investigate a potential link between azacitidine and pericarditis.
- A statistically significant signal was detected, with 48 reports of azacitidine-induced pericarditis.
Key Insights:
- The analysis revealed a strong association between azacitidine use and pericarditis, with a proportional reporting ratio of 5.0.
- Myelodysplastic syndrome (48%) and acute myelogenous leukemia (27%) were the primary indications for azacitidine in reported cases.
- Physicians and other healthcare professionals reported the majority of these adverse events.
Outlook:
- Clinicians should exercise caution and consider the risk of pericarditis when prescribing azacitidine.
- Early recognition and discontinuation of azacitidine may mitigate the risk of developing constrictive pericarditis, effusion, and tamponade.
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