A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events
A comprehensive pharmacovigilance surveillance on antibacterials is lacking. This study aims to investigate safety signals of antibacterial-related adverse drug events (ADEs) with seriousness and to identify predictors of serious ADEs. This study investigated 52,503 antibacterial-induced ADEs report...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-01-01
|
| Series: | Microorganisms |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-2607/13/1/136 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832587863790714880 |
|---|---|
| author | Seon Hu Mo Soo Hyeon Lee Chang-Young Choi Yongjun Sunwoo Sooyoung Shin Yeo Jin Choi |
| author_facet | Seon Hu Mo Soo Hyeon Lee Chang-Young Choi Yongjun Sunwoo Sooyoung Shin Yeo Jin Choi |
| author_sort | Seon Hu Mo |
| collection | DOAJ |
| description | A comprehensive pharmacovigilance surveillance on antibacterials is lacking. This study aims to investigate safety signals of antibacterial-related adverse drug events (ADEs) with seriousness and to identify predictors of serious ADEs. This study investigated 52,503 antibacterial-induced ADEs reported to the Korea Adverse Event Reporting System Database from January 2013 to December 2022. Disproportionality analysis was conducted, and the effect sizes were estimated by reporting odds ratios (ROR), proportional reporting ratio (PRR), and information component (IC). Multivariate logistic regression was performed to investigate the predictors of serious ADEs by estimating the odds ratio (OR). Serious events were more likely to be cardiovascular disorders (ROR 6.77, PRR 6.6, IC 2.37), urinary system disorders (ROR 5.56, PRR 5.22, IC 2.12), and platelet, bleeding, and clotting disorders (ROR 5.41, PRR 5.17, IC 2.06). The predictors may include age (OR 1.05), the number of concomitant medications (OR 1.44), concomitant proton pump inhibitors (OR 1.46) and non-steroidal anti-inflammatory drugs (OR 1.38) use, and specific antibacterial classes, while multiple antibacterial therapy was associated with lower serious ADE risks. The sensitivity analysis also suggests the male sex (OR 1.18) as a potential predictor of serious ADEs. However, further studies are imperative to determine the causality of antibacterial-induced ADEs in critically ill patients. |
| format | Article |
| id | doaj-art-8813f56709194fbda2b73531fa319ee9 |
| institution | Kabale University |
| issn | 2076-2607 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Microorganisms |
| spelling | doaj-art-8813f56709194fbda2b73531fa319ee92025-01-24T13:42:47ZengMDPI AGMicroorganisms2076-26072025-01-0113113610.3390/microorganisms13010136A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse EventsSeon Hu Mo0Soo Hyeon Lee1Chang-Young Choi2Yongjun Sunwoo3Sooyoung Shin4Yeo Jin Choi5Department of Pharmaceutical Science, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of KoreaDepartment of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of KoreaDepartment of Gastroenterology, Korea Medical Institute, Suwon 16553, Republic of KoreaDepartment of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of KoreaDepartment of Pharmacy, College of Pharmacy, Ajou University, Suwon 16499, Republic of KoreaDepartment of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of KoreaA comprehensive pharmacovigilance surveillance on antibacterials is lacking. This study aims to investigate safety signals of antibacterial-related adverse drug events (ADEs) with seriousness and to identify predictors of serious ADEs. This study investigated 52,503 antibacterial-induced ADEs reported to the Korea Adverse Event Reporting System Database from January 2013 to December 2022. Disproportionality analysis was conducted, and the effect sizes were estimated by reporting odds ratios (ROR), proportional reporting ratio (PRR), and information component (IC). Multivariate logistic regression was performed to investigate the predictors of serious ADEs by estimating the odds ratio (OR). Serious events were more likely to be cardiovascular disorders (ROR 6.77, PRR 6.6, IC 2.37), urinary system disorders (ROR 5.56, PRR 5.22, IC 2.12), and platelet, bleeding, and clotting disorders (ROR 5.41, PRR 5.17, IC 2.06). The predictors may include age (OR 1.05), the number of concomitant medications (OR 1.44), concomitant proton pump inhibitors (OR 1.46) and non-steroidal anti-inflammatory drugs (OR 1.38) use, and specific antibacterial classes, while multiple antibacterial therapy was associated with lower serious ADE risks. The sensitivity analysis also suggests the male sex (OR 1.18) as a potential predictor of serious ADEs. However, further studies are imperative to determine the causality of antibacterial-induced ADEs in critically ill patients.https://www.mdpi.com/2076-2607/13/1/136bacterial infectiondrug safetyantibacterialreal-world datapharmacovigilance |
| spellingShingle | Seon Hu Mo Soo Hyeon Lee Chang-Young Choi Yongjun Sunwoo Sooyoung Shin Yeo Jin Choi A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events Microorganisms bacterial infection drug safety antibacterial real-world data pharmacovigilance |
| title | A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events |
| title_full | A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events |
| title_fullStr | A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events |
| title_full_unstemmed | A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events |
| title_short | A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events |
| title_sort | comprehensive 10 year nationwide pharmacovigilance surveillance on antibacterial agents in korea data mining for signal detection of trends and seriousness of adverse events |
| topic | bacterial infection drug safety antibacterial real-world data pharmacovigilance |
| url | https://www.mdpi.com/2076-2607/13/1/136 |
| work_keys_str_mv | AT seonhumo acomprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT soohyeonlee acomprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT changyoungchoi acomprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT yongjunsunwoo acomprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT sooyoungshin acomprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT yeojinchoi acomprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT seonhumo comprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT soohyeonlee comprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT changyoungchoi comprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT yongjunsunwoo comprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT sooyoungshin comprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents AT yeojinchoi comprehensive10yearnationwidepharmacovigilancesurveillanceonantibacterialagentsinkoreadataminingforsignaldetectionoftrendsandseriousnessofadverseevents |