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
INTRODUCTION: Ibuprofen is commonly used as an over-the-counter (OTC) antipyretic and analgesic. As the frequency of its use increases, there has been a corresponding increase in reports of associated adverse events (AEs). However, these events have not been systematically reported in the literature. Meanwhile, the importance of effective pharmacovigilance in evaluating the benefits and risks of drugs is being recognized. METHODS: Data were obtained indirectly from FAERS using the OpenVigil 2 database, lexically mapped using software such as MySQL, Microsoft Excel, and the R language, and then subjected to four more rigorous algorithms to detect risk signals associated with ibuprofen AEs...
April 30, 2024: Expert Opinion on Drug Safety
Qing Huang, Yuanbin Wu, Huimin Li
BACKGROUND: This study aimed to analyze the adverse events to bendamustine using data obtained from the Food and Drug Administration open public data project (openFDA) and to provide a reference for its use in clinical practice. RESEARCH DESIGN AND METHODS: Adverse events (AEs) due to bendamustine usage reported from 1 January 2008 to 31 March 2023 were collected from the FDA Adverse Event Reporting System (FAERS). The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian plausible propagation neural network (BCPNN), and multinomial gamma-Poisson distribution shrinking (MGPS) algorithms were used to identify signs of adverse reactions caused by bendamustine...
April 29, 2024: Expert Opinion on Drug Safety
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, Setila Dalili, Hosseinali Kharazmi, Abdollah Didban, Aliasghar Akhlaghi, Sina Ghaznavi, Majid Shahbazi
OBJECTIVES: This study is designed in order to compare the efficacy and safety of recombinant human growth hormone (rhGH) with the reference brand. METHODS: According to the inclusion criteria, 85 people in 13 Iranian centers were randomly selected to receive biosimilar Somatropin (Somatin®) (44 people) and reference Somatropin (Norditropin®) (41 people) at a dose of 35 µg/kg/d, seven days/week for 12 months. The primary outcomes included height velocity (HV) was measured during 12 months of treatment...
April 29, 2024: Expert Opinion on Drug Safety
Xiangzhong Xue, Jingjing Qian
BACKGROUND: By 31 December 2022, the United States Food and Drug Administration (FDA) has approved 12 biosimilar monoclonal antibody cancer treatments. This study detected disproportionate adverse event (AE) reporting signals and compared safety profile of individual biosimilars to their originator biologics and between each pair of biosimilars. RESEARCH DESIGN AND METHODS: The FDA Adverse Event Reporting System data (6/1/2018-12/31/2022) was used to identify AE reports for rituximab, bevacizumab, trastuzumab, and their marketed biosimilars...
April 29, 2024: Expert Opinion on Drug Safety
Wolfgang Strube, Elias Wagner, Jurjen J Luykx, Alkomiet Hasan
INTRODUCTION: Effective side effects management present a challenge in antipsychotic treatment with second generation antipsychotics (SGAs). In recent years, most of the commonly used SGAs, except for clozapine, have been shown to differ only slightly in their effectiveness, but considerably regarding perceived side effects, safety profiles, and compatibility to preexisting medical conditions. AREAS COVERED: The current state of available evidence on side effect management in SGA treatment of patients with schizophrenia spectrum disorders (SSD) is reviewed...
April 27, 2024: Expert Opinion on Drug Safety
Tingxi Wu, Yanfeng Shi, Chang Xu, Bin Zhu, Dandan Li, Zhe Li, Zhigang Zhao, Yang Zhang
BACKGROUND: Polymyxins, including both colistin and polymyxin B (PMB), have regained clinical attention as last-line treatment options for treating infections caused by multidrug-resistant (MDR) gram-negative bacteria. Nonetheless, concerns persist regarding the toxicity associated with polymyxins. The objective of this study was to explore the potential severe adverse events (AEs) associated with polymyxins and compare the disparities in AEs between these two agents. METHODS: Records of AEs associated with colistin and PMB were retrieved from the U...
April 27, 2024: Expert Opinion on Drug Safety
YuBin He, Xin Guan, YaYun Zhang, Zixiong Zhu, YanHui Zhang, Yue Feng, Xuewen Li
BACKGROUND: our study aimed to identify inclisiran-related adverse events(AEs) for primary hypercholesterolemia and arteriosclerotic cardiovascular disease(ASCVD) from the US FDA Adverse Event Reporting System (FAERS) database, analyzing its links to AEs in the overall patient population and sex-specific subgroups to improve medication safety. METHODS: We analyzed inclisiran-related AEs signals by using statistical methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma-Poisson Shrinker (MGPS)...
April 27, 2024: Expert Opinion on Drug Safety
Kazumasa Yamamoto, Shun Yamamoto, Ken Kato
INTRODUCTION: 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...
April 27, 2024: Expert Opinion on Drug Safety
Yanhui Liu, Jinyang He, Xiaozhu Zhou, Yi Wu, Heping Cai, Yuquan Sun, Xiangli Cui
BACKGROUND: Recently, there have been some reports of seizures related with COVID-19 vaccinations. However, no studies have systematically investigated the relationship between seizures and various COVID-19 vaccines. RESEARCH DESIGN AND METHODS: This research aimed to analyze the characteristics and risk signals of new-onset seizures in children caused by various COVID-19 vaccines based on the data of the Vaccine Adverse Event Reporting System (VAERS). To identify potential risk signals, a disproportionality analysis was conducted...
April 26, 2024: Expert Opinion on Drug Safety
Pier Paolo Bocchino, Filippo Angelini, Guglielmo Gallone, Simone Frea, Gaetano Maria De Ferrari
No abstract text is available yet for this article.
April 25, 2024: Expert Opinion on Drug Safety
Qin-Yi Su, Liu Yang, Ting-Yu Cao, Hai-Ying Dang, Zhuo-Chen Han, Jia-Jing Cao, He-Yi Zhang, Ting Cheng, Sheng-Xiao Zhang, Yue-Hong Huo
BACKGROUND: Bimekizumab, a humanized monoclonal IgG1 antibody targeting both interleukin (IL)-17A and IL-17F, could be effective for treating Psoriatic arthritis (PsA). This study aimed to systematically evaluate the efficacy and safety of bimekizumab in the management of PsA. RESEARCH DESIGN AND METHODS: A comprehensive literature search by August 2023 was performed through PubMed, Embase, Cochrane Controlled Register of Trials, and investigating the efficacy or safety data of bimekizumab in the treatment of PsA...
April 22, 2024: Expert Opinion on Drug Safety
Fei Chu, Yang Yao, Bei Gao, Mingzhi Huang, Lingti Kong
BACKGROUND: Opioids are the most frequently used drugs to treat pain in cancer patients. However opioid analgesics can cause adverse effects and potential drug-drug interaction. RESEARCH DESIGN AND METHODS: This cross-sectional retrospective study analyzed pDDI in 1839 patients with opioid analgesics in a large comprehensive hospital in China from January 1 to 31 December 2022. Three drug interaction databases were used to screen for pDDI including Drugs (U.S.A...
April 20, 2024: Expert Opinion on Drug Safety
Hezhe Lu, Hui Yang, Zhexin Ding, Zhuoling An, Yong Zhao
BACKGROUND: Immune checkpoint inhibitors (ICIs) hold promise as treatment options for various types of cancer. However, recent case reports have brought attention to myositis, a potentially life-threatening complication associated with ICIs. This study aims to assess the spectrum of myositis associated with ICIs, including its clinical features, risk factors for fatal cases, adverse events (AEs) accompanying ICIs-related myositis, and the risk of myositis in different populations in real-world settings...
April 17, 2024: Expert Opinion on Drug Safety
Dipika Bansal, Beema T Yoosuf, Muhammed Favas Kt, Pinaki Dutta
BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: This is a retrospective study which explored the FAERS database till March 2023 for the collection of safety reports...
April 16, 2024: Expert Opinion on Drug Safety
Jinhua Chen, Weijiang Yu, Wancun Zhang, Cuicui Sun, Wenzhou Zhang
BACKGROUND: Evaluating antibiotics most commonly associated with pseudomembranous colitis (PMC) based on the real-world data is of great significance. RESEARCH DESIGN AND METHODS: We used the data from FAERS to evaluate the potential association between antibiotics and PMC by disproportionality analyzes. RESULTS: Eighty-one antibiotics which met the three algorithms simultaneously were enrolled. There were 1683 reports of PMC associated with the enrolled antibiotics...
April 11, 2024: Expert Opinion on Drug Safety
Mengjia Ying, Jian Shi, Yahao Ling, Tao Shi, Lele Liao, Linhui Cao
BACKGROUND: Lanthanum carbonate is widely used to manage serum phosphate and calcium levels in end-stage kidney disease (ESKD) patients, yet comprehensive long-term safety data are lacking. This study leverages the FDA Adverse Event Reporting System (FAERS) to assess the extended safety profile of lanthanum carbonate. RESEARCH DESIGN AND METHODS: We analyzed FAERS data (2004-2022) to study the association between lanthanum carbonate and adverse events (AEs). Using MedDRA v25...
April 11, 2024: Expert Opinion on Drug Safety
Xiaolin Yun, Yingying Zhou, Danna Wu, Yuanbo Liu, Qiongshi Wu
BACKGROUND: Daratumumab, a first-in-class humanized IgG1κ monoclonal antibody that targets the CD38 epitope, has been approved for treatment of multiple myeloma by FDA. The current study was to evaluate daratumumab-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of daratumumab-associated AEs...
April 10, 2024: Expert Opinion on Drug Safety
Harriet Aprilia Dickinson, Jan Feifel, Katoo Muylle, Taichi Ochi, Enriqueta Vallejo-Yagüe
Artificial intelligence or machine learning (AI/ML) based systems can be used to help personalize prescribing decisions for individual patients. These AI/ML clinical decision support systems may provide either specific or more open-ended recommendations for the most appropriate medications to prescribe. These systems must fundamentally relate to the label of the medicines involved. The label of a medicine is an approved guide that indicates how to prescribe the drug in a safe and effective manner. The label for a medicine may evolve as new information on safety and effectiveness emerges, leading to the addition or removal of warnings, drug-drug interactions, or to permit new indications...
April 10, 2024: Expert Opinion on Drug Safety
Khushboo Bisht, Bharathi Mohan, Basavaraj Jatteppanavar, Hannah Theresa Sony, Shailendra Handu, Minakshi Dhar
INTRODUCTION: Medication errors are inherent in a healthcare system. This results in both time and cost burdens for both the patient and the health system. The aim of this study was to conduct a root-cause analysis of medication errors in elderly patients with methotrexate toxicity, analyze associated factors, and propose solutions. METHODS: This single-center prospective study was designed to identify medication errors in cases of methotrexate toxicity between November 2022 to May 2023...
April 4, 2024: Expert Opinion on Drug Safety
Xianlin Li, Nan Shang, Qianci Yan, Xiunan Yue, Yang Liu, Xiaojun Zheng
BACKGROUND: This study analyzed the bleeding adverse events (AEs) resulting from the treatment of B-cell lymphoma with Bruton tyrosine kinase (BTK) inhibitors, according to reports in the US Food and Drug Administration's Adverse Event Reporting System (FAERS). METHODS: Bleeding AEs associated with BTK inhibitors (including ibrutinib, zanubrutinib, and acalabrutinib) from the first quarter of 2013 to the third quarter of 2023 were extracted. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were reported...
April 3, 2024: Expert Opinion on Drug Safety
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