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Age-stratified analysis of adverse event signals for clarithromycin: a disproportionality analysis using the FDA
Haiyan Mai1, Zhenpo Zhang2, Yankun Liang2
1The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
Insights
Clarithromycin safety varies by age, with distinct adverse events (AEs) in children and adults. This study analyzed FAERS data to identify age-specific clarithromycin AEs for better clinical management.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background:
- Clarithromycin is a widely prescribed antibiotic.
- Its safety profile across different age demographics requires further investigation.
Purpose of the Study:
- To characterize and analyze clarithromycin-related adverse events (AEs) across various age groups.
- To utilize the FDA Adverse Event Reporting System (FAERS) database for comprehensive safety profiling.
- To provide a reference for clinical detection, prevention, and management of clarithromycin AEs in diverse populations.
Main Methods:
- Disproportionality analysis of AE reports in the FAERS database.
- Stratification of clarithromycin AE reports by age groups (0-17, 18-44, 45-64, ⩾65 years).
- Application of statistical methods including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multiple gamma Poisson shrinkers.
Main Results:
- Analysis of 7319 clarithromycin AE reports.
- Identified frequent AEs varied by age group: vomiting (0-17), diarrhea (18-44), drug interactions (45-64), and drug interactions (⩾65 years).
- Detected 41 significant AE signals not listed in the package insert, predominantly psychiatric, skin, and gastrointestinal disorders, with 18 age-specific signals.
Conclusions:
- Clarithromycin exhibits distinct safety profiles across different age groups.
- Pediatric AEs include vomiting, hypersensitivity, and dyspnea.
- Adults experience more psychiatric AEs, and the elderly require caution due to drug interactions.
Background:
Clarithromycin is a widely used antibiotic, but its safety profile, particularly in different age groups, remains inadequately explored.
Objectives:
This study aims to characterize and illustrate the features of clarithromycin-related adverse events (AEs) across different age groups using the FDA Adverse Event Reporting System (FAERS) database, providing a reference for the clinical detection, prevention, and management of AEs in various age groups.
Design:
A disproportionality analysis was performed using data from the FAERS database. The study included all AE reports related to clarithromycin, stratified by age groups.
Methods:
Disproportionality analysis was conducted using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multiple gamma Poisson shrinkers. Statistical analyses included descriptive statistics and Chi-square tests.
Results:
A total of 7319 reports of clarithromycin AEs were retrieved from the FAERS database. Vomiting, diarrhea, drug interactions, and drug interactions were reported most frequently in the age groups 0-17, 18-44, 45-64, and ⩾65 years, respectively. Abnormal product taste, taste disorder, and medication errors related to drug interactions specified in the package insert were the strongest signals in the age groups 0-17, 18-44, 45-64, and ⩾65 years, respectively. A total of 41 Preferred Terms signals were not explicitly included in the clarithromycin package insert and were mainly associated with psychiatric disorders, skin and subcutaneous tissue disorders, and gastrointestinal disorders, among others. Specific signals for age differences were identified, with 18 signals being age-specific, including 3 in children and 15 in elderly individuals.
Conclusion:
The safety profile of clarithromycin varies across age groups. In children, it is mainly associated with vomiting, hypersensitivity, and dyspnea, while in adults, psychiatric AEs are more common. In the elderly, clarithromycin should be used cautiously, with attention to drug interactions.
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