Development and validation of a machine learning model to improve precision prediction for irrational prescriptions in orthopedic perioperative patients
CONCLUSION: The RF model showcased significantly high level of proficiency in predicting irrational prescriptions among orthopedic perioperative patients, outperforming other models by a considerable margin. It effectively enhanced the efficiency of pharmacist interventions, displaying outstanding performance in assisting pharmacists to intervene with irrational prescriptions.PMID:38698685 | DOI:10.1080/14740338.2024.2348569 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 3, 2024 Category: Drugs & Pharmacology Authors: Weipeng Li Nan Shang Zhiqi Zhang Yun Li Xianlin Li Xiaojun Zheng Source Type: research

Efficacy and safety of deucravacitinib for the management of psoriasis: a drug safety evaluation
Expert Opin Drug Saf. 2024 May 3. doi: 10.1080/14740338.2024.2351462. Online ahead of print.ABSTRACTINTRODUCTION: Nowadays, despite the wide availability of biological drugs and apremilast for psoriasis management, there is always a need for new therapies to customize the therapeutic approach on the basis of the patient's clinical features and comorbidities, especially in order to achieve a prolonged therapeutic response. Thus, new treatment strategies are required to offer patients a personalized approach. In this scenario, major knowledge on psoriasis pathogenesis led to the development of deucravacitinib, an orally admi...
Source: Expert Opinion on Drug Safety - May 3, 2024 Category: Drugs & Pharmacology Authors: Luca Potestio Nello Tommasino Giuseppe Lauletta Federica Feo Angelo Ruggiero Fabrizio Martora Antonio Portarapillo Luigi Guerriero Matteo Megna Source Type: research

A narrative review of the comparative safety of disease-modifying anti-rheumatic drugs used for the treatment of rheumatoid arthritis
Expert Opin Drug Saf. 2024 May 2. doi: 10.1080/14740338.2024.2348575. Online ahead of print.ABSTRACTINTRODUCTION: Disease modifying anti-rheumatic drugs (DMARDs) have improved the outcomes of patients with rheumatoid arthritis (RA). DMARDs are classified into three categories: conventional synthetic DMARDs, biological DMARDs (including biosimilars), and targeted synthetic DMARDs. DMARDs, by way of their effect on the immune system, are associated with increased risk of adverse events, including infections, malignancies, cardiovascular disease, gastrointestinal perforations, and other less common events.AREAS COVERED: In th...
Source: Expert Opinion on Drug Safety - May 2, 2024 Category: Drugs & Pharmacology Authors: Rouhin Sen Maria Riofrio Jasvinder A Singh Source Type: research

A real-world pharmacovigilance analysis of the FDA adverse event reporting system events for polatuzumab vedotin
CONCLUSIONS: Our study identified significant new AE signals for polatuzumab vedotin through real-world disproportionality analysis data and may provide additional evidence for risk identification of polatuzumab vedotin.PMID:38695550 | DOI:10.1080/14740338.2024.2348572 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 2, 2024 Category: Drugs & Pharmacology Authors: Zhongliang Xu Dan Huang Qiusha Liu Sha Liu Jiating Liu Hongli Wang Zhengze Shen Source Type: research

Intraocular inflammation as a Major Adverse Event of Anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration: from clinical trials to real-world practice
Expert Opin Drug Saf. 2024 May 2. doi: 10.1080/14740338.2024.2351468. Online ahead of print.NO ABSTRACTPMID:38696228 | DOI:10.1080/14740338.2024.2351468 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 2, 2024 Category: Drugs & Pharmacology Authors: Jae Hui Kim Source Type: research

A real-world disproportionality analysis of FDA adverse event reporting system events for ibuprofen
CONCLUSION: The study explores the important and valuable potential AEs and ADRs of ibuprofen at the SOC and PT levels, respectively. To provide a reference for decision-making for ibuprofen to promote rational clinical dosing.PMID:38686498 | DOI:10.1080/14740338.2024.2348556 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Authors: Yikuan Du Zhuoming Guo Bijun Xu Yujia Yang Mianda Hu Yanghui Hu Yurong Yang Mengting Zhang Zhenjie Wang Xiaochun Guo Yixing Huang Jinfeng Zhu Weichui Zhang Chun Yang Source Type: research

Comparison of safety of acetaminophen and ibuprofen in minors: based on the FAERS database
CONCLUSIONS: The use of acetaminophen and ibuprofen in children of different age groups has different characteristics. Pediatric clinical pharmacists can provide medication monitoring to minimize ADEs based on these characteristics.PMID:38686870 | DOI:10.1080/14740338.2024.2348614 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Authors: Jing Wang Guowen Feng Dan Li Xiaodan Zhou Jia Chen Fengdie Wang Li Chen Source Type: research

A real-world disproportionality analysis of FDA adverse event reporting system events for ibuprofen
CONCLUSION: The study explores the important and valuable potential AEs and ADRs of ibuprofen at the SOC and PT levels, respectively. To provide a reference for decision-making for ibuprofen to promote rational clinical dosing.PMID:38686498 | DOI:10.1080/14740338.2024.2348556 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Authors: Yikuan Du Zhuoming Guo Bijun Xu Yujia Yang Mianda Hu Yanghui Hu Yurong Yang Mengting Zhang Zhenjie Wang Xiaochun Guo Yixing Huang Jinfeng Zhu Weichui Zhang Chun Yang Source Type: research

Comparison of safety of acetaminophen and ibuprofen in minors: based on the FAERS database
CONCLUSIONS: The use of acetaminophen and ibuprofen in children of different age groups has different characteristics. Pediatric clinical pharmacists can provide medication monitoring to minimize ADEs based on these characteristics.PMID:38686870 | DOI:10.1080/14740338.2024.2348614 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Authors: Jing Wang Guowen Feng Dan Li Xiaodan Zhou Jia Chen Fengdie Wang Li Chen Source Type: research

A real-world disproportionality analysis of FDA adverse event reporting system events for ibuprofen
CONCLUSION: The study explores the important and valuable potential AEs and ADRs of ibuprofen at the SOC and PT levels, respectively. To provide a reference for decision-making for ibuprofen to promote rational clinical dosing.PMID:38686498 | DOI:10.1080/14740338.2024.2348556 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Authors: Yikuan Du Zhuoming Guo Bijun Xu Yujia Yang Mianda Hu Yanghui Hu Yurong Yang Mengting Zhang Zhenjie Wang Xiaochun Guo Yixing Huang Jinfeng Zhu Weichui Zhang Chun Yang Source Type: research

Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database
CONCLUSIONS: Findings call for large, longitudinal studies to examine causality of certain AEs with rituximab-pvvr and bevacizumab biosimilars.PMID:38680112 | DOI:10.1080/14740338.2024.2348577 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 29, 2024 Category: Drugs & Pharmacology Authors: Xiangzhong Xue Jingjing Qian Source Type: research

Evaluation of the safety and efficacy of biosimilar recombinant growth hormone in children with growth hormone deficiency: non-inferiority, randomized, parallel, multicentric and Phase III trial
CONCLUSIONS: The finding of this study indicated that Somatin® and Norditropin® have comparable efficacy and safety profiles.CLINICAL TRIAL REGISTRATION: www.IRCT.ir IRCT20171122037571N1.PMID:38682328 | DOI:10.1080/14740338.2024.2348576 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 29, 2024 Category: Drugs & Pharmacology Authors: Hossein Zaeri Shahriar Omidvar Nazli Servatian Serajaddin Arefnia Nasrin Khademolreza Hossein Amini Behnam Taghavi Mahin Hashemipour Peyman Eshraghi Mahmoud Ghasemi Robabeh Ghergherehchi Elham Maleki Hossein Moravej Shahab Noorian Fahimeh Soheilipour Seti Source Type: research

Signal detection of adverse reactions for bendamustine based on FDA adverse event reporting system
CONCLUSION: Our findings identified numerous common AEs with previously reported clinical observations. We also identified some signs of potential new AEs, indicating the need of careful clinical monitoring of patients treated with bendamustine and further risk identification research about this drug.PMID:38682580 | DOI:10.1080/14740338.2024.2348573 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 29, 2024 Category: Drugs & Pharmacology Authors: Qing Huang Yuanbin Wu Huimin Li Source Type: research

Pembrolizumab for recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus: a drug safety evaluation
Expert Opin Drug Saf. 2024 Apr 27. doi: 10.1080/14740338.2024.2348554. Online ahead of print.ABSTRACTINTRODUCTION: The prognosis of advanced esophageal squamous cell carcinoma (ESCC) remains poor and few effective drugs are available. Cisplatin plus 5-FU (CF) has been the standard first-line treatment for advanced ESCC. However, in the KEYNOTE-181 trial, the clinical outcomes were better in patients with programmed death ligand 1 (PD-L1)-positive advanced ESCC who received pembrolizumab, an immune checkpoint inhibitor (ICI), than in those who received cytotoxic agents as second-line treatment. Moreover, the KEYNOTE-590 tri...
Source: Expert Opinion on Drug Safety - April 27, 2024 Category: Drugs & Pharmacology Authors: Kazumasa Yamamoto Shun Yamamoto Ken Kato Source Type: research

Analysis of Inclisiran in the US FDA adverse event reporting system (FAERS): a focus on overall patient population and Sex-specific Subgroups
CONCLUSION: Our study revealed the strongest AE signals associated with inclisiran in both the overall population and gender subgroups, highlighting potential risks in clinical medication use and guiding balanced clinical decision-making.PMID:38676389 | DOI:10.1080/14740338.2024.2348562 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 27, 2024 Category: Drugs & Pharmacology Authors: YuBin He Xin Guan YaYun Zhang Zixiong Zhu YanHui Zhang Yue Feng Xuewen Li Source Type: research