Article
Pharmacology & Pharmacy
Rui Xiong, Jing Lei, Sicen Pan, Hong Zhang, Yongtao Tong, Wei Wu, Yi Huang, Xiaodan Lai
Summary: This study investigated and analyzed the post-marketing adverse event data of the multiple sclerosis therapeutic drug dalfampridine, finding new adverse event signals. The results provide reference for the safe use of dalfampridine in the treatment of multiple sclerosis.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yamin Shu, Yufeng Ding, Yanxin Liu, Pan Wu, Xucheng He, Qilin Zhang
Summary: This study used data mining of the FAERS to evaluate secukinumab-associated adverse events and identified potential new signals of adverse events, providing a broader understanding of secukinumab's safety profiles.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Xiang-Ping Wu, Xi-Kui Lu, Zhen-Ting Wang, Ling Huang, Ru-Wen Cai, Hui-Min Yu, Jing-Yang Li, Jian Xiao
Summary: This study assessed the adverse events associated with Upadacitinib and found potential new signals, which could provide important support for clinical monitoring and risk identification.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Oncology
N. E. Omar, A. I. Fahmy Soliman, M. Eshra, T. Saeed, A. Hamad, A. Abou-Ali
Summary: Analysis of FAERS data revealed significant safety signals for several ALK inhibitors, including risks related to eye disorders, respiratory disorders, and metabolism disorders. Further regulatory investigation is needed to verify the significance of these signals and potentially update product labels.
Article
Immunology
John R. Su, Michael M. McNeil, Kerry J. Welsh, Paige L. Marquez, Carmen Ng, Ming Yan, Maria Cano
Summary: A thorough analysis of myopericarditis reports to a national vaccine safety surveillance system in the United States revealed that most cases involved males with symptoms occurring within two weeks post-vaccination. Smallpox and anthrax vaccines were the most commonly reported vaccines associated with myopericarditis.
Article
Pharmacology & Pharmacy
Tingting Jiang, Hui Su, Yanping Li, Yuanlin Wu, Yue Ming, Chen Li, Ruoqiu Fu, Lu Feng, Ziwei Li, Li Li, Rui Ni, Yao Liu
Summary: The study investigates the safety profiles and differences of immunomodulatory drugs (IMiDs) in treating multiple myeloma (MM) patients. Using the U.S. FDA Adverse Event Reporting System (FAERS), the study identifies important safety signals associated with IMiDs and analyzes their characteristics. The findings highlight the significance of these drugs' safety reports and call for further investigation.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Medicine, General & Internal
Kalyani Sonawane, Yueh-Yun Lin, Haluk Damgacioglu, Yenan Zhu, Maria E. Fernandez, Jane R. Montealegre, Cecilia Ganduglia Cazaban, Ruosha Li, David R. Lairson, Ying Lin, Anna R. Giuliano, Ashish A. Deshmukh
Summary: By analyzing data from the National Immunization Survey and Vaccine Adverse Event Reporting System from 2015 to 2018, it was found that parents' safety concerns regarding the HPV vaccine have increased, while trends in adverse event reporting have not changed significantly. These findings suggest an urgent need to address caregivers' safety concerns in order to increase HPV vaccine confidence.
Review
Immunology
Yuhong Wang, Chen Chen, Wei Du, Yixin Zhou, Lina He, Shaodong Hong, Li Zhang
Summary: This study evaluated the reporting quality of adverse events (AE), especially immune-related AE (irAE), in immunotherapy clinical trials. A total of 123 publications were included and assessed using a 16-point harm reporting quality score (HRQS). The findings showed that AE reporting in immunotherapy trials is suboptimal, highlighting the need for improvement and standardization of reporting practices.
FRONTIERS IN IMMUNOLOGY
(2022)
Article
Clinical Neurology
Alexandra N. Cocores, Peter J. Goadsby, Teshamae S. Monteith
Summary: This study assessed the characteristics and associated disability of headache as an adverse event following vaccination. Headache is a common symptom of vaccines, but there is a lack of systematic investigations on post-licensure reports of this adverse event.
Article
Immunology
Pedro L. Moro, Jessica Leung, Paige Marquez, Yeowon Kim, Shaokui Wei, John R. Su, Mona Marin
Summary: This study analyzed data from the United States Vaccine Adverse Event Reporting System (VAERS) to update the safety information of single-antigen varicella vaccine (VAR) and combination measles, mumps, rubella, and varicella vaccine (MMRV). The results showed that there were no new or unexpected safety concerns for VAR and MMRV when administered as recommended.
JOURNAL OF INFECTIOUS DISEASES
(2022)
Review
Oncology
Diego Enrico, Federico Waisberg, Jeannette Burton, Pablo Mando, Matias Chacon
Summary: The study systematically reviewed the quality of adverse events reports in oncology trials and found that the reporting and attribution process were more unreliable than expected. A high proportion of trials did not provide complete adverse event attribution reports, and journals with lower impact factors were associated with deficient reporting of grade 3-4 adverse events.
CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
(2021)
Article
Medicine, General & Internal
Yang Bai, Bin Wu, Liangwen Gou, Zhenwei Fang, Ting Xu, Tiejun Zhang, Yuwen Li
Summary: This study investigated the cardiovascular toxicity of febuxostat and allopurinol using the FDA Adverse Event Reporting System (FAERS) database. The results showed that compared to allopurinol, febuxostat may increase the risk of cardiovascular adverse events in patients with gout.
JOURNAL OF CLINICAL MEDICINE
(2023)
Review
Immunology
Cindra Tri Yuniar, Bhekti Pratiwi, Ardika Fajrul Ihsan, Bambang Tri Laksono, Iffa Risfayanti, Annisa Fathadina, Yeonseon Jeong, Eunyoung Kim
Summary: This study aims to assess the quality of harm reporting in clinical trials for the COVID-19 vaccine and identify associated factors. The majority of the trials demonstrated adequate reporting, but there were shortcomings in handling recurrent events and subgroup analysis.
Article
Oncology
Zaoqin Yu, Rui Huang, Li Zhao, Ximin Wang, Xiaofang Shangguan, Wei Li, Min Li, Xianguo Yin, Chengliang Zhang, Dong Liu
Summary: This study conducted post-marketing surveillance on the safety profile of Oxaliplatin (OXA) in Chinese cancer patients, revealing a high incidence of adverse drug reactions, with particular attention to hypersensitivity reactions caused by OXA.
FRONTIERS IN ONCOLOGY
(2021)
Article
Dentistry, Oral Surgery & Medicine
H. Diakonoff, G. Khalil, S. Jungo, J. M. Treluyer, H. Fron-Chabouis, V. Smail-Faugeron
Summary: Less than one-quarter of oral health trials are registered in a public registry. The study highlights the high rate of nonpublication and selective outcome reporting in the field of oral health.
JOURNAL OF DENTAL RESEARCH
(2023)
Article
Biochemistry & Molecular Biology
Matthew B. Dong, Guangchuan Wang, Ryan D. Chow, Lupeng Ye, Lvyun Zhu, Xiaoyun Dai, Jonathan J. Park, Hyunu R. Kim, Youssef Errami, Christopher D. Guzman, Xiaoyu Zhou, Krista Y. Chen, Paul A. Renauer, Yaying Du, Johanna Shen, Stanley Z. Lam, Jingjia J. Zhou, Donald R. Lannin, Roy S. Herbst, Sidi Chen
Letter
Pediatrics
Michael S. Toce, Kenneth A. Michelson, Krista Y. Chen, Joel D. Hudgins, Karen L. Olson, Florence T. Bourgeois
Article
Oncology
Krista Y. Chen, Aleksandra Popovic, David Hsiehchen, Marina Baretti, Paige Griffith, Ranjan Bista, Azarakhsh Baghdadi, Ihab R. Kamel, Sanford M. Simon, Rachael D. Migler, Mark Yarchoan
Summary: This study demonstrates that immune checkpoint inhibitors (ICIs) have modest clinical activity in the treatment of fibrolamellar hepatocellular carcinoma (FLC). The results have important implications for the management and treatment decisions for FLC patients.
Article
Oncology
Krista Y. Chen, Amanda L. Blackford, Ramy Sedhom, Arjun Gupta, S. M. Qasim Hussaini
Summary: There are disparities in healthcare spending and cancer mortality rates among US counties. This study examined how local county-level social vulnerability affects cancer-related mortality. The researchers linked county-level mortality rates and social vulnerability index, finding that the highest mortality risks were observed in Southern and rural counties, individuals aged 45-65, and patients with lung and colorectal cancers.