| アブストラクト | 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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| 組織名 | Department of Pharmacy, Fujian Maternity and Child Health Hospital, College of;Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical;University, Fuzhou, China.;University, Fuzhou, China. pollyzhang2006@126.com. |
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