Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database
Abstract This study aims to evaluate the safety of Alprazolam by analyzing the FAERS database, provide data analysis for monitoring adverse drug reactions. This research encompasses adverse event (AE) reports related to Alprazolam from the first quarter of 2004 to the second quarter of 2023. Four si...
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| Format: | Article |
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Nature Portfolio
2024-03-01
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| Series: | Scientific Reports |
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| Online Access: | https://doi.org/10.1038/s41598-024-57909-y |
| _version_ | 1797233627800535040 |
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| author | Feng Huang Xiao San Qingqian Liu Haohao Zhu Wenrong Xu |
| author_facet | Feng Huang Xiao San Qingqian Liu Haohao Zhu Wenrong Xu |
| author_sort | Feng Huang |
| collection | DOAJ |
| description | Abstract This study aims to evaluate the safety of Alprazolam by analyzing the FAERS database, provide data analysis for monitoring adverse drug reactions. This research encompasses adverse event (AE) reports related to Alprazolam from the first quarter of 2004 to the second quarter of 2023. Four signal mining and analysis methods were utilized, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Further exploration was conducted regarding patient characteristics and types of AEs. A total of 23,575 AE reports in which Alprazolam was the primary suspect drug were collected, identifying 347 Preferred Term (PT) signals and 27 System Organ Classes (SOCs). The number of AE reports increased annually, especially in 2015, 2018, 2019, and 2020. The main affected groups were females and the age range of 18 to 45. Psychiatric disorders, Nervous system disorders, and Gastrointestinal disorders were the most common the organ system in which the AEs occurred. There is a certain risk of drug abuse and suicide with Alprazolam. Most notably, several AEs not recorded in the Alprazolam leaflet appeared among the top 30 PTs in signal strength, including but not limited to Benzodiazepine drug level abnormal, Acquired amegakaryocytic thrombocytopenia, Cutaneous T-cell dyscrasia, and Coronary No-reflow Phenomenon. For the first time, AEs related to the cardiovascular system and platelet function were unveiled. The severe AE reports that resulted in "hospitalization" and "death" accounted for 30.96% and 21.86%. This study highlights the risks of suicide and misuse of Alprazolam. Other potential severe or fatal AEs, such as those related to the cardiovascular system, platelet function, and others, require further research to determine their precise mechanisms and risk factors. |
| first_indexed | 2024-04-24T16:19:11Z |
| format | Article |
| id | doaj.art-e2f78a8b10e54e3e811cd17a9cf48454 |
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| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-24T16:19:11Z |
| publishDate | 2024-03-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-e2f78a8b10e54e3e811cd17a9cf484542024-03-31T11:18:43ZengNature PortfolioScientific Reports2045-23222024-03-011411910.1038/s41598-024-57909-ySignal mining and risk analysis of Alprazolam adverse events based on the FAERS databaseFeng Huang0Xiao San1Qingqian Liu2Haohao Zhu3Wenrong Xu4Department of Clinical Laboratory, Kunshan Maternity and Children’s Health Care HospitalJiangsu Key Laboratory of Medical Science and Laboratory Medicine, School of Medicine, Jiangsu UniversityDepartment of Clinical Laboratory, The First People’s Hospital of Kunshan Affiliated With Jiangsu UniversityMental Health Center of Jiangnan University, Wuxi Central Rehabilitation HospitalJiangsu Key Laboratory of Medical Science and Laboratory Medicine, School of Medicine, Jiangsu UniversityAbstract This study aims to evaluate the safety of Alprazolam by analyzing the FAERS database, provide data analysis for monitoring adverse drug reactions. This research encompasses adverse event (AE) reports related to Alprazolam from the first quarter of 2004 to the second quarter of 2023. Four signal mining and analysis methods were utilized, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Further exploration was conducted regarding patient characteristics and types of AEs. A total of 23,575 AE reports in which Alprazolam was the primary suspect drug were collected, identifying 347 Preferred Term (PT) signals and 27 System Organ Classes (SOCs). The number of AE reports increased annually, especially in 2015, 2018, 2019, and 2020. The main affected groups were females and the age range of 18 to 45. Psychiatric disorders, Nervous system disorders, and Gastrointestinal disorders were the most common the organ system in which the AEs occurred. There is a certain risk of drug abuse and suicide with Alprazolam. Most notably, several AEs not recorded in the Alprazolam leaflet appeared among the top 30 PTs in signal strength, including but not limited to Benzodiazepine drug level abnormal, Acquired amegakaryocytic thrombocytopenia, Cutaneous T-cell dyscrasia, and Coronary No-reflow Phenomenon. For the first time, AEs related to the cardiovascular system and platelet function were unveiled. The severe AE reports that resulted in "hospitalization" and "death" accounted for 30.96% and 21.86%. This study highlights the risks of suicide and misuse of Alprazolam. Other potential severe or fatal AEs, such as those related to the cardiovascular system, platelet function, and others, require further research to determine their precise mechanisms and risk factors.https://doi.org/10.1038/s41598-024-57909-yAlprazolamFAERSReal-world data analysisAdverse eventsAdverse drug reaction |
| spellingShingle | Feng Huang Xiao San Qingqian Liu Haohao Zhu Wenrong Xu Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database Scientific Reports Alprazolam FAERS Real-world data analysis Adverse events Adverse drug reaction |
| title | Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database |
| title_full | Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database |
| title_fullStr | Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database |
| title_full_unstemmed | Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database |
| title_short | Signal mining and risk analysis of Alprazolam adverse events based on the FAERS database |
| title_sort | signal mining and risk analysis of alprazolam adverse events based on the faers database |
| topic | Alprazolam FAERS Real-world data analysis Adverse events Adverse drug reaction |
| url | https://doi.org/10.1038/s41598-024-57909-y |
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