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A pharmacovigilance study of daptomycin use in infants under 1 year old based on the FDA adverse event reporting
Lingling Ye1, Guimu Guo1, Hong Zhou1
1Department of Pharmacy, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China.
Insights
Daptomycin safety in infants under one year old is uncertain. This study identified potential adverse event signals, including hepatic cytolysis and DRESS, using FAERS data, highlighting risks in this population.
Area of Science:
- Pharmacovigilance and Drug Safety
- Pediatric Pharmacology
- Real-World Evidence Research
Background:
- The safety profile of daptomycin in infants under one year old requires further investigation.
- Existing data on daptomycin's adverse events (AEs) in neonates and infants is limited.
- Real-world data can offer insights into potential safety signals in special pediatric populations.
Purpose of the Study:
- To identify potential adverse event (AE) signals associated with daptomycin use in infants under one year old.
- To leverage the Food and Drug Administration Adverse Event Reporting System (FAERS) database for pharmacovigilance.
- To assess the strength of AE signals using multiple disproportionality analysis algorithms.
Main Methods:
- Utilized the FAERS database from Q1 2004 to Q2 2024 for real-world pharmacovigilance.
- Employed disproportionality analyses: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), MGPS, and BCPNN.
- Conducted a subgroup analysis on data from the past 5 years to refine signal detection.
Main Results:
- Identified 8 potential daptomycin AE risk signals across 3 System Organ Classes (SOCs) in infants under one year old.
- Strongest associations included hepatobiliary disorders (ROR 8.54), renal and urinary disorders (ROR 4.55), and infections (ROR 3.68).
- Top AE signals were hepatic cytolysis (ROR 297.93) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (ROR 92.54). Subgroup analysis confirmed hepatic cytolysis and DRESS as significant signals.
Conclusions:
- New daptomycin AE signals, particularly hepatic cytolysis and DRESS, were identified in infants under one year old.
- Findings support enhanced risk monitoring for daptomycin use in this vulnerable pediatric population.
- The FAERS database limitations necessitate cautious interpretation; further research is required to confirm these safety signals.
Abstract:
The safety of daptomycin in infants under 1 year old remains uncertain. This study aimed to identify signals potentially associated with daptomycin use in this special population based on the Food and Drug Administration adverse event reporting system (FAERS). Real-world pharmacovigilance research was conducted on the FAERS database from Q1 2004 to Q2 2024. Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN), were used to assess the strength of AEs signals for daptomycin. A subgroup analysis was conducted on the data from the past 5 years to further explore the association between AEs and daptomycin. A total of 96 AEs of daptomycin as the primary suspected drug used in infants under 1 year old were reported, and 8 risk signals involving 3 system organ classes(SOCs) were identified as simultaneously meeting the 4 algorithms. The strongest associations were observed for hepatobiliary disorders (ROR 8.54), renal and urinary disorders (ROR 4.55), infections and infestations (ROR 3.68) in SOCs, and the top 4 signal intensities of AEs were hepatic cytolysis (ROR 297.93), drug reaction with eosinophilia and systemic symptoms (DRESS) (ROR 92.54), acute kidney injury (ROR 20.99), hypotension (ROR 14.10). In the subgroup analysis, 4 positive risk signals for AEs were identified, which were distributed across 3 SOCs. Among these, hepatobiliary disorders (ROR 10.98) topped the list. The strongest associations were observed for hepatic cytolysis (ROR 226.08), DRESS (ROR 110.04) in positive risk signals. The results highlight the new daptomycin AEs signals in younger infants and provide vital risk monitoring and identification support. In our analysis, hepatic cytolysis and DRESS were the most significant risk signals, and no positive signals related to the nervous system were observed. Additionally, due to the limitations of the FAERS, the correlation between AEs and daptomycin warrants cautious interpretation, and further explorations in the future are required.
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