| アブストラクト | BACKGROUND: Mycophenolate mofetil (MMF) is widely used in solid-organ transplantation and autoimmune diseases. Spontaneous-reporting databases may assist in identifying adverse-event reporting patterns that warrant further clinical evaluation. This study characterized MMF-associated reports in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: FAERS reports submitted from the first quarter of 2004 through the fourth quarter of 2024 were analyzed. After deduplication, reports listing MMF as the primary suspect drug were included. Medication-use, therapeutic-response, product-related, administrative, and outcome-only Preferred Terms were excluded from the primary clinical adverse-event signal analysis. Disproportionality was evaluated using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and Multi-item Gamma Poisson Shrinker. Time-to-onset distributions were described only for reports with valid treatment-start and event dates. RESULTS: A total of 44,671 MMF primary-suspect reports were included, of which 32,577 (72.9%) were classified as serious and 5589 (12.5%) included a reported fatal outcome. Valid time-to-onset information was available for 5433 reports (12.2%). Among this subset, 1333 reports (24.5%) had a recorded onset within 30 days, and 1978 (36.4%) had a recorded onset more than 360 days after treatment initiation. These proportions describe the distribution of reports with complete dates and do not represent incidence or time-dependent risk. Prominent reporting associations involved opportunistic infections and hematologic abnormalities, although substantial confounding by transplantation status, underlying disease, and concomitant immunosuppressive therapy remained. CONCLUSIONS: FAERS reports involving MMF showed disproportionality associations for several clinically relevant events. These findings indicate reporting patterns rather than causal relationships or estimates of clinical risk. The time-to-onset findings were based on a small subset of reports with complete dates and should be interpreted descriptively. Confirmation using indication-specific longitudinal datasets with reliable exposure denominators is required. Key Points * Four complementary disproportionality methods were used to prioritize MMF-associated reporting signals in FAERS. * Non-clinical medication-use and therapeutic-response terms were separated from clinical adverse-event signals. * Time-to-onset information was available for only 12.2% of reports and was interpreted as a descriptive reporting distribution. * Confounding by indication and concomitant immunosuppressants limits attribution of the detected signals to MMF. |
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| 投稿者 | Wang, Qiaofen; Xie, Hongqiang; Zhong, Long; Liu, Duopeng; Zhu, Mengna; Huang, Zihao; Zhou, Jiayao; Yang, Yu; Yang, Zhou |
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| 組織名 | Department of Medicine, Hainan Medical University, Haikou, 570311, China.;Department of Rheumatology and Immunology, Hainan Affiliated Hospital of Hainan;Medical University (Hainan General Hospital), Haikou, 570311, China.;Department of Intensive Care Unit, Nanjing Drum Tower Hospital Clinical College;of Xuzhou Medical University, Nanjing, China.;Shenzhen University Medical School, Shenzhen University, Shenzhen, 518061, China.;Department of Urology, Peking University Shenzhen Hospital, Shenzhen, 518036,;China.;Institute of Urology, Shenzhen Peking University-The Hong Kong University of;Science and Technology Medical Center, Shenzhen, 518036, China.;Shenzhen Clinical Research Center for Urology and Nephrology, Shenzhen, 518036,;Department of Critical Care Medicine, Shenzhen Second People's Hospital,;Shenzhen, 518035, China.;School of Clinical Medicine, Anhui Medical University, Anhui, Hefei, 231200,;School of Medicine, The Chinese University of Hong Kong, Shenzhen, 518172, China.;Department of Digestive Medicine, Peking University Shenzhen Hospital, Shenzhen,;518036, China. 18681930338@163.com.;China. yangyu@pkuszh.com.;yangyu@pkuszh.com.;yang835329@163.com. |
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