Article
Pharmacology & Pharmacy
Shu Tang, Zhanshen Wu, Liqing Xu, Qiang Wen, Xiaojian Zhang
Summary: This study conducted a pharmacovigilance analysis using FAERS and found adverse reaction signals for ticagrelor and clopidogrel. Clinicians should be cautious when using these drugs.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Chemistry, Medicinal
Meng Li, Qing-Song Zhang, Xin-Ling Liu, Hui-Ling Wang, Wei Liu
Summary: This study evaluates adverse events associated with the use of Nirmatrelvir/ritonavir using the FDA Adverse Event Reporting System. The results show a significant association between Nirmatrelvir/ritonavir and disease recurrence, while no signal of disease recurrence is detected for other COVID-19 drugs. Adverse event reports did not differ significantly based on patient gender or age.
Article
Endocrinology & Metabolism
X. Shi, Q. Cheng, Y. -z. Zhao, S. -p. Zou, M. -h. Sun
Summary: This study evaluated the safety signals of Abaloparatide (ABL) using data mining of the FDA pharmacovigilance database. It found that ABL was associated with adverse events such as growing pains, increased waist circumference, sensory disturbance, tinnitus, reduced visual acuity, increased blood alkaline phosphatase, and abnormal hair growth. The study also suggested that patient age may be associated with the severity of adverse events.
OSTEOPOROSIS INTERNATIONAL
(2023)
Article
Pharmacology & Pharmacy
Zheng Yang, Yuhuan Lv, Meng Yu, Mei Mei, Linyu Xiang, Subei Zhao, Rong Li
Summary: The study utilized the FDA Adverse Event Reporting System (FAERS) database to explore the association between GLP-1RA and various types of neoplasms. While most types of tumors did not show a disproportionate increase, significant signals were detected for certain tumors such as thyroid cancer and pancreatic neoplasms, indicating a potential risk in these cases.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Linlin Tang, Chuanhua Ding, Hongying Li, Guoqiang Yin, Haixia Zhang, Wen Shan Liu, Yinghui Ji, Hui Li
Summary: This study analyzed adverse events (AEs), especially hemorrhage, of bevacizumab using the FAERS database. The study found a total of 96,477 AE reports, with 2,847 cases of hemorrhage. Hemorrhagic signals were mainly concentrated in vascular, gastrointestinal, and nervous system disorders.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Pharmacology & Pharmacy
Linlin Tang, Chuanhua Ding, Hongying Li, Guoqiang Yin, Haixia Zhang, Wen Shan Liu, Yinghui Ji, Hui Li
Summary: This study analyzed adverse events (AEs) of bevacizumab, particularly focusing on hemorrhage, using the FAERS database. It found that hemorrhage was a significant AE associated with bevacizumab, along with other important organ system disorders related to the drug.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Public, Environmental & Occupational Health
Yamin Shu, Xucheng He, Pan Wu, Yanxin Liu, Yufeng Ding, Qilin Zhang
Summary: This study evaluated the gastrointestinal safety signals associated with semaglutide by mining the FDA pharmacovigilance database. It identified several new adverse signals and found that patient age and body weight might be associated with the severity of gastrointestinal adverse events. Different clinical priority signals were defined and it was observed that the risk of gastrointestinal adverse events decreased over time.
FRONTIERS IN PUBLIC HEALTH
(2022)
Article
Pharmacology & Pharmacy
Si Su, Liuqing Wu, Guibao Zhou, Lingling Peng, Huanzhe Zhao, Xiao Wang, Kuan Li
Summary: This study investigates the adverse events associated with denosumab and zoledronic acid, compares their association strengths, and explores potential off-label applications. The analysis of the FAERS database provides valuable postmarketing surveillance data and highlights the necessity for safety monitoring when using these drugs off-label.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yamin Shu, Qilin Zhang, Xucheng He, Yanxin Liu, Pan Wu, Li Chen
Summary: This study systematically explored the association between fluoroquinolones and tendonitis and tendon rupture using the FAERS database. Fluoroquinolones were found to be associated with serious outcomes and early occurrence of tendonitis and tendon rupture. Ciprofloxacin showed the strongest association with tendonitis, while levofloxacin showed the strongest association with tendon rupture.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Pan Ma, Xinmei Pan, Ruixiang Liu, Ya Qu, Linli Xie, Jiangchuan Xie, Liya Cao, Yongchuan Chen
Summary: This study analyzed adverse event reports submitted to the US Food and Drug Administration to identify and characterize ocular adverse events associated with anti-VEGF drugs for the treatment of neovascular age-related macular degeneration. The results showed differences in adverse events between different drugs, emphasizing the importance of clinical attention and personalized treatment based on the patient's medical condition.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Chenxin Chen, Ting Chen, Jizhou Liang, Xiaojing Guo, Jinfang Xu, Yi Zheng, Zhijian Guo, Lijie Chi, Lianhui Wei, Xiao Chen, Xiaofei Ye, Jia He
Summary: This study investigated the relationship between cardiotoxicity and immune checkpoint inhibitors (ICIs), identifying a higher reporting frequency in males compared to females, as well as a higher proportion of serious outcomes in males. ICIs were associated with an over-reporting of cardiotoxicities, with PD-1 and PD-L1 showing a link to cardiac adverse events. Anti-CTLA-4 was significantly associated with specific adverse events. The spectrum of ICI-induced cardiotoxicities varied between different agents, with myocarditis being a common serious complication across all ICIs.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Pharmacology & Pharmacy
Hui Zhao, Jun-Min Li, Zi-Ran Li, Qian Zhang, Ming-Kang Zhong, Ming-Ming Yan, Xiao-Yan Qiu
Summary: A study found that testosterone replacement treatment (TRT) may increase the risk of cardiovascular events such as myocardial infarction and cardiomyopathy in men. However, TRT showed beneficial effects in populations with conditions such as testosterone deficiency, diabetes mellitus, and hypertension. These cardiovascular events are rare but have serious consequences.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yi Zheng, Xiaojing Guo, Chenxin Chen, Lijie Chi, Zhijian Guo, Jizhou Liang, Lianhui Wei, Xiao Chen, Xiaofei Ye, Jia He
Summary: This study explored the clinical characteristics, outcomes, and time to onset of the four main toxicities of secukinumab using post-marketing data. Adverse events such as diarrhea, nasopharyngitis, pruritus, and rash were identified, with high-risk signals including inflammatory bowel disease, genital candidiasis, psoriasiform dermatitis, and anosmia.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Xiang Zhou, Xiaofei Ye, Xiaojing Guo, Dongxu Liu, Jinfang Xu, Fangyuan Hu, Yinghong Zhai, Yongqing Gao, Xiao Xu, Ziwei Dong, Jia He
Summary: The study investigated the distribution of adverse events related to SGLT2 inhibitors in different systems and identified important medical event signals. Most SGLT2 inhibitor-related important medical events occurred during monotherapy, with common strong signals including diabetic ketoacidosis and ketoacidosis. Unexpected safety signals such as cellulitis and nephrolithiasis were detected.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Medicine, General & Internal
Greta Santi Laurini, Nicola Montanaro, Domenico Motola
Summary: In order to evaluate the safety profile of molnupiravir, adverse event reports related to the drug were analyzed. Out of the 612 reports submitted to the FDA, 49.18% were related to females and 45.92% to males. The majority of reports were submitted by healthcare professionals and a significant proportion reported serious outcomes. The most commonly reported adverse reactions included diarrhea, rash, nausea, and COVID-19 pneumonia, which were consistent with the safety evaluation of the drug.
JOURNAL OF CLINICAL MEDICINE
(2023)