LI Qing-tong, ZHOU Zhi-yong, PENG Qing-lan, ZHAO Shuang
Objective: To mine and analyze adverse drug events (ADEs) of four antibacterial drugs (vancomycin, linezolid, teicoplanin and daptomycin) used for treating pediatric methicillin-resistant Staphylococcus aureus (MRSA) infections in the real world based on the U.S. FDA Adverse Events Reporting System (FAERS) database, so as to provide evidence for safe and rational clinical medication. Methods: By using "vancomycin", "linezolid", "teicoplanin" and "daptomycin" as keywords, ADEs with these drugs as the suspected drugs from January 1, 2004 to June 30, 2024 were searched in the FAERS database, and related information on ADEs was collected to analyze the clinical characteristics of the associated ADEs. Results: After screening in the FAERS database, the numbers of eligible ADE reports for vancomycin, linezolid, teicoplanin and daptomycin were 3 707, 1 004, 460 and 196 respectively, and the numbers of included ADE signals were 285, 115, 77 and 29 respectively. Among the included ADEs, reports of linezolid, teicoplanin and daptomycin were mainly from Europe, including 416 cases (41.43%), 357 cases (77.61%) and 157 cases (80.10%) respectively, while vancomycin reports were predominantly from the United States (1 253 cases, 33.80%) and Europe (1 242 cases, 33.50%). Regarding age distribution, vancomycin recipients were concentrated at 0 to less than 6 years (1 498 cases, 40.41%); linezolid users showed a relatively balanced age distribution; teicoplanin was mostly used in patients aged 12 to less than 18 years (199 cases, 43.26%); daptomycin was mainly administered to those aged 6 to less than 12 years (137 cases, 69.90%). For gender distribution (excluding unknown or unclear cases), males outnumbered females in all groups, with male-to-female ratios of 1.24 (vancomycin), 1.60 (linezolid), 1.09 (teicoplanin) and 2.70 (daptomycin) respectively. Positive ADE signal reports and signals of the four drugs were classified by system organ class (SOC). Vancomycin involved 23 SOCs (the most diverse), followed by linezolid (20), teicoplanin (15) and daptomycin (11). "Infections and infestations" and "systemic diseases and administration site conditions" were among the top 5 SOCs for all four agents, while other involved SOCs differed. ADEs of the four antibacterial drugs all showed strong associations with "infections and infestations". In terms of Preferred Terms (PT), vancomycin presented a strong signal and high report count for "vancomycin infusion reaction"; linezolid showed a prominent signal strength in "nervous system diseases", such as "toxic neuropathy" and "dysdiadochokinesia". For teicoplanin, ADE signals including "ventricular thrombosis", "myocardial injury" and "ankylosis" each had only 3 reports but showed strong correlation, and were not documented in the package insert. For daptomycin, apart from "delayed therapeutic response" and "non-responder to treatment", its ADE signals were mostly concentrated in "metabolism and nutrition disorders", consistent with its high-frequency ADE profiles. Conclusion: There are both similarities and differences in SOCs involved in ADEs of the four antibacterial drugs, which can guide the clinical selection of appropriate antibacterial drugs to maintain therapeutic efficacy while improving medication safety in pediatric patients.
