Article
Pharmacology & Pharmacy
Zhi-Xuan Zhou, Xue-Dong Yin, Yu Zhang, Qi-Hui Shao, Xin-Yu Mao, Wen-Juan Hu, Yun-Lin Shen, Bin Zhao, Zhi-Ling Li
Summary: Antifungal drugs are significantly associated with drug-induced liver injury (DILI), with itraconazole and voriconazole having the greatest risk of liver injury. More clinical studies are needed to confirm the safety of echinocandins due to indication bias.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Immunology
Yamin Shu, Jing Chen, Yiling Ding, Qilin Zhang
Summary: This study evaluated risankizumab-associated adverse events (AEs) and characterized the clinical priority through data mining of the FDA Adverse Event Reporting System (FAERS). The study found potential new AE signals and provided valuable evidence for clinicians to mitigate the risk of risankizumab-associated AEs.
FRONTIERS IN IMMUNOLOGY
(2023)
Article
Pharmacology & Pharmacy
Zhihong Fang, Zhiqiang Xu, Wei Zhu, Mingming Yu, Chunmei Ji
Summary: Through data mining of the United States Food and Drug Administration Adverse Event Reporting System, we assessed the safety profiles of apalutamide in the real-world. Common adverse events observed in patients receiving apalutamide included rash, fatigue, diarrhea, hot flush, and fall. The most significant system organ class was skin and subcutaneous tissue disorders, mainly consisting of dermatological adverse events.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yan Wu, Meihao Wei, Jing Zhang
Summary: The adverse drug event (ADE) signals of upadacitinib were mined from the FDA Adverse Event Reporting System (FAERS) database to provide evidence for its safe clinical use. Several ADEs occurred more frequently in systems not covered in the drug labeling information, including renal and urinary system, reproductive and breast diseases, ear and labyrinth disorders, psychiatric disease, blood and lymphatic system disorders, and endocrine disorders. High-frequency events leading to serious adverse events were mainly related to urinary tract infection, herpes zoster, diverticulitis, and bronchitis.
FRONTIERS IN PHARMACOLOGY
(2023)
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
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)
Article
Pharmacology & Pharmacy
Feifei Wang, Bingfeng Zhou, Hongwei Sun, Xinan Wu
Summary: This study aimed to identify different associations between antiarrhythmic drugs (AADs) and arrhythmias and determine if pharmacokinetic drug interactions involving AADs increase the risk of AAD-related arrhythmias compared to using AADs alone. Data from January 2016 to June 2022 was analyzed to detect potential safety signals. The results showed varied spectrum and risk of AAD-associated cardiac arrhythmias among different AAD therapies.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Dongxuan Li, Jinghui Gou, Jun Zhu, Tongyan Zhang, Feng Liu, Daojun Zhang, Liyang Dai, Wenjun Li, Qinglong Liu, Chunmeng Qin, Qian Du, Songqing Liu
Summary: This study provides a comprehensive landscape of culprit-drugs for severe cutaneous adverse reactions (SCARs) by analyzing reports from the FDA Adverse Event Reporting System database. It reveals the risk characteristics of different drugs and may help optimize patient management.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Bing Cao, Shanshan Gu, Zhisen Shen, Yuna Zhang, Yiming Shen, Hang Chen
Summary: This study collected data from the FAERS database to evaluate the adverse events induced by Ubrogepant. It identified new adverse events that have not been reported before, providing new guidance for understanding the safety of Ubrogepant.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Medicine, Research & Experimental
Austin R. Swisher, Rijul S. Kshirsagar, Nithin D. Adappa, Jonathan Liang
Summary: The study evaluated the adverse reactions of dupilumab in treating chronic rhinosinusitis with nasal polyps (CRSwNP). Analysis of FAERS data showed that CRSwNP-tx had fewer individual DAR compared to other treatment indications, with women and older adults experiencing more iDAR, while men tended to have more serious DAR.
Article
Pharmacology & Pharmacy
Chunmei Ji, Jinmei Bai, Jiancheng Zhou, Ying Zou, Mingming Yu
Summary: Background: Proprotein convertase subtilisin/kexin type (PCSK9) inhibitors are a new drug class approved for treating dyslipidemias. In this study, we investigated the safety profiles of PCSK9 inhibitors (alirocumab and evolocumab) using the FDA Adverse Event Reporting System (FAERS). Methods: We analyzed adverse event reports submitted to FAERS from 2015Q3 to 2021Q1. Results: The FAERS database documented 31,475 reports regarding PCSK9 inhibitors. Alirocumab and evolocumab had similar safety profiles with common adverse events including injection-site reactions, muscle-related AEs, and influenza-like illness. Conclusion: Data mining of FAERS proved useful in examining PCSK9 inhibitor-induced AEs, and the findings were consistent with clinical experience, providing insights for improving the safety of these drugs in clinical practice.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Xue-Feng Jiao, Kunpeng Song, Xueyan Jiao, Hailong Li, Linan Zeng, Kun Zou, Wei Zhang, Huiqing Wang, Lingli Zhang
Summary: This study comprehensively evaluates the association between various antihypertensive drugs and hyperuricaemia, gout, and related adverse events (AEs). The findings suggest that certain potassium-sparing diuretics, calcium channel blockers, and losartan may be associated with an increased risk of hyperuricaemia, gout, and related AEs, contradicting previous studies. Additionally, antihypertensive drugs with central action, alpha and beta blockers, renin inhibitors, and vasodilators may also be associated with an increased risk, which has not been reported in previous studies.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Immunology
Chen Chen, Bin Wu, ChenYu Zhang, Ting Xu
Summary: This study analyzed immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) and found different characteristics of irAEs among different ICI regimens. Pembrolizumab had the highest fatality proportion, while ipilimumab plus pembrolizumab had the shortest median time to onset irAEs. Further studies are needed to assess potential clinically relevant differences among ICIs.
INTERNATIONAL IMMUNOPHARMACOLOGY
(2021)
Article
Dermatology
Andrew D. Monnot, Ernest S. Fung, Goli S. Compoginis, Kevin M. Towle
Summary: This study analyzed the impact of negative media coverage on product complaints using the CAERS database, with WCD cleansing conditioner as a case study. The results showed a significant increase in adverse event reporting rate after negative media coverage, highlighting the importance of considering external factors in product safety evaluations.
JOURNAL OF COSMETIC DERMATOLOGY
(2021)
Article
Immunology
Kelly J. Gambino-Shirley, Adiam Tesfai, Colin A. Schwensohn, Cindy Burnett, Lori Smith, Jennifer M. Wagner, Dana Eikmeier, Kirk Smith, Jolianne P. Stone, Dawn Updike, Jonas Hines, Lauren N. Shade, Beth Tolar, Tong-Jen Fu, Stelios Viazis, Sharon L. Seelman, Kathryn Blackshear, Matthew E. Wise, Karen P. Neil
CLINICAL INFECTIOUS DISEASES
(2018)
Article
Oncology
Grazia Arnbrosini, Sharon L. Seehnan, Li-Xuan Qin, Gary K. Schwartz
Article
Oncology
Grazia Ambrosini, Sharon L. Seelman, Gary K. Schwartz
Article
Oncology
Grazia Ambrosini, Haider S. Cheema, Sharon Seelman, Allison Teed, Elliot B. Sambol, Samuel Singer, Gary K. Schwartz
MOLECULAR CANCER THERAPEUTICS
(2008)
Article
Public, Environmental & Occupational Health
Sarah Luna, Marsha Taylor, Eleni Galanis, Rod Asplin, Jasmine Huffman, Darlene Wagner, Linda Hoang, Ana Paccagnella, Susan Shelton, Stephen Ladd-Wilson, Sharon Seelman, Brooke Whitney, Elisa Elliot, Robin Atkinson, Katherine Marshall, Colin Basler
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
(2018)
Article
Pediatrics
Rashida Hassan, Sharon Seelman, Vi Peralta, Hillary Booth, Mackenzie Tewell, Beth Melius, Brooke Whitney, Rosemary Sexton, Asha Dwarka, Duc Vugia, Jeff Vidanes, David Kiang, Elysia Gonzales, H. Natasha Dowell, Samantha M. Olson, Lori M. Gladney, Michael A. Jhung, Karen P. Neil
Article
Biotechnology & Applied Microbiology
Kari Irvin, Stelios Viazis, Angela Fields, Sharon Seelman, Karen Blickenstaff, Ellen Gee, Matthew E. Wise, Katherine E. Marshall, Laura Gieraltowski, Stic Harris
Summary: Leafy greens contaminated with Shiga toxin-producing E. coli have caused several foodborne illness outbreaks, with challenges in identifying the source of contamination. By examining traceback investigations of three outbreaks linked to romaine lettuce in 2018 and 2019, opportunities for improvement in traceback investigations were identified to ultimately prevent future outbreaks.
JOURNAL OF FOOD PROTECTION
(2021)
Article
Biotechnology & Applied Microbiology
Brooke M. Whitney, Monica McClure, Rashida Hassan, Mary Pomeroy, Sharon L. Seelman, Lauren N. Singleton, Tyann Blessington, Cerise Hardy, Joseph Blankenship, Evelyn Pereira, Chelsea N. Davidson, Yan Luo, James Pettengill, Phillip Curry, Terri McConnell, Laura Gieraltowski, Colin Schwensohn, Colin Basler, Kevin Fritz, Crystal McKenna, Kenneth Nieves, Janete Oliveira, Ana Lilia Sandoval, Alvin Crosby, D'ann Williams, Kia Crocker, Deepam Thomas, Tara Fulton, Loel Muetter, Lan Li, Enoma Omoregie, Kelsey Holloman, Christy Brennan, Nikeya Thomas, Amber Barnes, Stelios Viazis
Summary: In 2017 and 2019, outbreaks of Salmonella infections linked to the consumption of Maradol papayas in the United States resulted in 325 ill persons. Investigations identified papayas as the likely source and traced them back to four farms in Mexico. This information was used to enhance food safety requirements for papayas imported from Mexico.
JOURNAL OF FOOD PROTECTION
(2021)
Article
Public, Environmental & Occupational Health
Michelle A. Waltenburg, Colin Schwensohn, Asma Madad, Sharon L. Seelman, Vi Peralta, Sarah E. Koske, Michelle M. Boyle, Katherine Arends, Kane Patel, Mia Mattioli, Laura Gieraltowski, Karen P. Neil
Summary: Leafy green vegetables, particularly romaine lettuce, are common sources of outbreaks caused by Shiga toxin-producing E. coli O157:H7, with cattle being the main reservoir. Recurring strains of STEC O157 led to multistate outbreaks linked to romaine lettuce consumption in 2018 and 2019, highlighting the need for better understanding of mechanisms of contamination and prevention strategies.
EPIDEMIOLOGY AND INFECTION
(2021)
Article
Public, Environmental & Occupational Health
Sharon L. Seelman, Michael C. Bazaco, Allison Wellman, Cerise Hardy, Marianne K. Fatica, Mei-Chiung Jo Huang, Anna-Marie Brown, Kimberly Garner, William C. Yang, Carla Norris, Heather Moulton-Meissner, Julie Paoline, Cara Bicking Kinsey, Janice J. Kim, Moon Kim, Dawn Terashita, Jason Mehr, Alvin J. Crosby, Stelios Viazis, Matthew B. Crist
Summary: In March 2018, multiple US organizations investigated an outbreak of Burkholderia cepacia complex (Bcc) infections, which were linked to a no-rinse cleansing foam product. The FDA conducted an inspection of the manufacturer's facility and found poor manufacturing practices. Analysis confirmed a match between the product samples and clinical isolates. The manufacturer conducted a recall and public communications were issued to warn healthcare providers and facilities.
EPIDEMIOLOGY AND INFECTION
(2022)
Article
Food Science & Technology
Sharon. L. L. Seelman, Brooke. M. M. Whitney, Erin. K. K. Stokes, Elisa. L. L. Elliot, Taylor Griswold, Kane Patel, Steven Bloodgood, Jessica. L. L. Jones, Jennifer Cripe, Jason Cornell, Yan Luo, D'Ann L. Williams, Michelle. M. M. Boyle, Jordan Cahoon, Christy Brennan, Laura. M. M. Wildey, Victoria. M. M. Grover, Sean Simonson, Alvin. J. J. Crosby, Michael. C. C. Bazaco, Stelios Viazis
Summary: V. parahaemolyticus is the leading cause of seafood-related foodborne illness globally. In 2018, a multistate outbreak of V. parahaemolyticus infections linked to imported crabmeat from Venezuela occurred in the United States, resulting in illnesses and hospitalizations. The investigation identified the contaminated food and country of origin, leading to regulatory actions and highlighting the importance of adhering to food safety practices for imported seafood.
FOODBORNE PATHOGENS AND DISEASE
(2023)
Article
Immunology
Katherine E. Marshall, April Hexemer, Sharon L. Seelman, Marianne K. Fatica, Tyann Blessington, Maha Hajmeer, Hannah Kisselburgh, Robin Atkinson, Kristin Hill, Davendra Sharma, Michael Needham, Vi Peralta, Jeffrey Higa, Karen Blickenstaff, Ian T. Williams, Michael A. Jhung, Matthew Wise, Laura Gieraltowski
EMERGING INFECTIOUS DISEASES
(2020)
Article
Public, Environmental & Occupational Health
M. Laughlin, L. Bottichio, J. Weiss, J. Higa, E. McDonald, R. Sowadsky, D. Fejes, A. Saupe, G. Provo, S. Seelman, J. Concepcion-Acevedo, L. Gieraltowski, J. Narang, M. Needham, A. Barnes, A. Maroufi, H. Buonomo, C. Neiss, L. Negado, J. Healy, F. Ni, K. Trinh, L. McCullough, C. Rigdon, J. Ayers, E. Reed, S. Viazis, A. Crosby, A. Tesfai, S. Lance, L. Whitlock, E. Trees, D. Wagner, A. Sabot, I Williams
EPIDEMIOLOGY AND INFECTION
(2019)
Article
Public, Environmental & Occupational Health
Kristina M. Angelo, Alvina Chu, Madhu Anand, Thai-An Nguyen, Lyndsay Bottichio, Matthew Wise, Ian Williams, Sharon Seelman, Rebecca Bell, Marianne Fatica, Susan Lance, Deanna Baldwin, Kyle Shannon, Hannah Lee, Eija Trees, Errol Strain, Laura Gieraltowski
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
(2015)