Adverse events associated with azithromycin and clarithromycin in adults aged ≥65: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database
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Zhenpo Zhang1, Jiaxin He2, Yankun Liang1
1Department of Pharmacy, Jinan University, Guangzhou, Guangdong, China.
Background:
Azithromycin and clarithromycin are commonly used to treat community-acquired pneumonia in adults aged ≥ 65, such as mycoplasma pneumonia. This study aims to evaluate adverse events (AEs) associated with azithromycin and clarithromycin in this age group by analyzing the FDA Adverse Event Reporting System (FAERS), providing insights for clinical use and management of AEs in this population.
Research Design And Methods:
We retrieved reports of AEs related to azithromycin and clarithromycin from the FAERS database. Disproportionality analysis was conducted using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Gamma Poisson Shrinkage (MGPS) to identify AEs associated with azithromycin and clarithromycin in adults aged ≥ 65.
Results:
A total of 2,019 adverse event reports were retrieved for azithromycin, and 2,392 for clarithromycin. Off-label use (n = 349) and drug interactions (n = 487) were the most reported AEs in adults aged ≥ 65 for azithromycin and clarithromycin, respectively. Prolonged QT interval showed the strongest signal among AEs for azithromycin in this age group. Drug interaction-related medication errors had the strongest signal for clarithromycin. Seven signals not explicitly included in the azithromycin package insert were identified in adults aged ≥ 65. Fourteen signals not explicitly included in the clarithromycin package insert were identified.
Conclusions:
Among adults aged ≥ 65, cardiac-related adverse events are more closely associated with azithromycin than with clarithromycin. Conversely, AEs related to drug interactions and psychiatric symptoms are more associated with clarithromycin. Additionally, clinicians should be vigilant regarding AEs not specified in the package inserts. The findings of this study may help optimize the selection of azithromycin and clarithromycin based on patient circumstances and assist clinicians in focusing on relevant AEs for early intervention.
Insights
Azithromycin is linked to cardiac events, while clarithromycin is associated with drug interactions and psychiatric issues in older adults. Both macrolides have potential adverse events not listed in their package inserts, requiring clinical vigilance.
Area of Science:
- Pharmacovigilance
- Geriatric Medicine
- Infectious Diseases
Background:
- Azithromycin and clarithromycin are frequently prescribed for community-acquired pneumonia in adults aged 65 and older.
- Mycoplasma pneumonia is a common indication for these macrolide antibiotics in this demographic.
Purpose of the Study:
- To evaluate and compare adverse events (AEs) associated with azithromycin and clarithromycin in adults aged 65 and above.
- To identify specific safety signals and potential risks for each antibiotic in the geriatric population.
Main Methods:
- Analysis of the FDA Adverse Event Reporting System (FAERS) database.
- Utilized disproportionality analyses, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Gamma Poisson Shrinkage (MGPS).
Main Results:
- Over 2,000 reports for azithromycin and nearly 2,400 for clarithromycin were analyzed.
- Azithromycin showed a stronger signal for prolonged QT interval (cardiac events), while clarithromycin had a stronger signal for drug interaction-related medication errors.
- Off-label use was a significant AE for azithromycin, and drug interactions for clarithromycin. Several safety signals not listed in package inserts were identified for both drugs.
Conclusions:
- Azithromycin is more associated with cardiac AEs, whereas clarithromycin is linked to drug interactions and psychiatric AEs in older adults.
- Clinicians should be aware of potential AEs not detailed in package inserts and consider patient-specific factors when prescribing these antibiotics.
- This study aids in optimizing antibiotic selection and AE management in geriatric patients.
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