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Hematological adverse events associated with anti-MRSA agents: a real-world analysis based on FAERS
Xiuheng Yu1, Xiaodan Zhou1, Min Li2
1Department of Pharmacy, University Town Hospital, Chongqing Medical University, Chongqing, China.
Abstract:
This study investigated the patterns of hematological adverse events related to daptomycin (DAP), tigecycline (TIG), vancomycin (VAN) and linezolid (LIN) in the FDA Adverse Event Reporting System (FAERS). Adverse event associations were analyzed through calculating reporting odds ratio (ROR), proportional reporting ratio (PRR), multiple gamma Poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN). A comprehensive descriptive analysis was also conducted considering factors such as age, gender, daily dose, cumulative dose, and time to onset. The leading hematologic adverse events were eosinophilia for daptomycin, coagulation abnormalities and thrombocytopenia for tigecycline, thrombocytopenia, neutropenia, and anemia for linezolid, and thrombocytopenia, eosinophilia, and neutropenia for vancomycin. Most of the affected patients were over 55 years old. Daily doses for the tigecycline and daptomycin groups exceeded the standard daily dose. The times to onset were 14.00 days for daptomycin (interquartile range [IQR], 4.00-21.00), 6.00 days for tigecycline (IQR, 2.00-9.00), 10.00 days for linezolid (IQR, 4.00-16.5), and 10.00 days for vancomycin (IQR,5.00-20.00). It is essential to intensify early monitoring and identification of these adverse events, especially in the context of off-label dosages and for elderly patients and individuals taking medication for over one week.
Insights
Hematologic adverse events like eosinophilia, coagulation abnormalities, and thrombocytopenia are linked to daptomycin, tigecycline, vancomycin, and linezolid. Monitoring is crucial, especially for elderly patients and those on higher or longer-term doses.
Area of Science:
- Pharmacovigilance and Drug Safety
- Hematology
- Infectious Diseases
Background:
- Antibiotics such as daptomycin (DAP), tigecycline (TIG), vancomycin (VAN), and linezolid (LIN) are critical for treating serious infections.
- Hematological adverse events (HAEs) are potential risks associated with these drugs.
- Understanding the specific HAE profiles of these antibiotics is essential for safe clinical use.
Purpose of the Study:
- To investigate and characterize the patterns of HAEs associated with DAP, TIG, VAN, and LIN.
- To identify specific HAEs linked to each antibiotic class.
- To analyze factors influencing HAEs, including patient demographics, dosage, and time to onset.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database for adverse event data.
- Employed statistical methods including reporting odds ratio (ROR), proportional reporting ratio (PRR), multiple gamma Poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN) for association analysis.
- Conducted a descriptive analysis of patient age, gender, daily dose, cumulative dose, and time to onset.
Main Results:
- Daptomycin was associated with eosinophilia; tigecycline with coagulation abnormalities and thrombocytopenia; linezolid with thrombocytopenia, neutropenia, and anemia; vancomycin with thrombocytopenia, eosinophilia, and neutropenia.
- Most affected patients were over 55 years old.
- Off-label higher daily doses were observed for tigecycline and daptomycin, with varying times to onset for HAEs (e.g., 6 days for tigecycline, 10 days for linezolid and vancomycin, 14 days for daptomycin).
Conclusions:
- Specific HAE profiles are associated with daptomycin, tigecycline, vancomycin, and linezolid.
- Elderly patients, those on higher-than-standard doses, and those treated for over a week are at increased risk.
- Enhanced monitoring and early identification of HAEs are recommended for these antibiotics, particularly in high-risk populations and off-label use scenarios.
