Results 31 to 40 of about 15,628 (311)

Methods to Compare Adverse Events in Twitter to FAERS, Drug Information Databases, and Systematic Reviews: Proof of Concept with Adalimumab [PDF]

, 2018
Introduction: Adverse drug reactions (ADRs) are associated with significant health-related and financial burden, and multiple sources are currently utilized to actively discover them.
Golder, Su, Gonzalez-Hernandez, Graciela, Loke, Yoon, O’Connor, Karen, Sarker, Abeed, Smith, Karen   +5 more
core   +2 more sources

Second Primary Malignancies After Commercial CAR T Cell Therapy: Analysis of FDA Adverse Events Reporting System (FAERS).

Blood
Second primary malignancies (SPMs) were reported in 536 out of 12,394 (4.3%) adverse event reports following CAR T cell therapies in the FDA Adverse Event Reporting System (FAERS).
Magdi Elsallab, Moataz Ellithi, M. Lunning, Christopher R D'Angelo, Jihyun Ma, M. Perales, M. Frigault, M. Maus   +7 more
semanticscholar   +1 more source

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Scientific Reports, 2022
Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was
Yanchao Yin, Yamin Shu, Junru Zhu, Feie Li, Juan Li   +4 more
doaj   +1 more source

Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter [PDF]

, 2014
Background: Traditional adverse event (AE) reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event.
Bao, Wenjie, Brownstein, John S., Dasgupta, Nabarun, Filice, Ross, Freifeld, Clark C., Kass-Hout, Taha, Menone, Christopher M.   +6 more
core   +3 more sources

Adverse drug events associated with linezolid administration: a real-world pharmacovigilance study from 2004 to 2023 using the FAERS database

Frontiers in Pharmacology
Introduction: Linezolid is an oxazolidinone antibiotic that is active against drug-resistant Gram-positive bacteria and multidrug-resistant Mycobacterium tuberculosis. Real-world studies on the safety of linezolid in large populations are lacking.
Fan Zou, Zhiwei Cui, Siyu Lou, Yingyong Ou, Chengyu Zhu, Chengjie Shu, Junyou Chen, Ruizhen Zhao, Zhu Wu, Li Wang, Zhenyong Chen, Huayu Chen, Yuanbo Lan   +12 more
semanticscholar   +1 more source

Bisphosphonate-related ocular adverse events: a pharmacovigilance study based on the FAERS database

Endocrine Connections
This retrospective study aimed to identify and characterize signals of ocular adverse events (AEs) related to bisphosphonates (BPs) using FDA adverse event reporting system (FAERS) data (Q1 2004 to Q3 2024) to inform future safety investigations ...
Yue Cui, Zhihui Song, Xinglong Wang
doaj   +1 more source

Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]

, 2018
BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron, Avant, Debbie, Baer, Gerri, Burckart, Gilbert J., Moore, Jason N., Sorbello, Alfred, Wang, Jian, Yao, Lynne, Zheng, Panli   +8 more
core   +3 more sources

Romosozumab adverse event profile: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) from 2019 to 2023

Aging Clinical and Experimental Research
This study aims to analyze adverse drug events (ADE) related to romosozumab from the second quarter of 2019 to the third quarter of 2023 from FAERS database. The ADE data related to romosozumab from 2019 Q2 to 2023 Q3 were collected.
Luyu Liu, Shaobo Wu, Liangliang Wei, Zhihao Xia, Jiajia Ji, Dageng Huang   +5 more
semanticscholar   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

An exploratory study evaluating the 20 medications most commonly associated with suicidal ideation and self-injurious behavior in the FAERS database

BMC Pharmacology and Toxicology
A number of pharmaceuticals, including antidepressants and antiepileptics, have a strong correlation with suicide risk. However, it is not entirely clear which of these medications are more strongly associated with suicide-related behaviors.
Wen-long Xie, Dao-chun Xiang, Yuan-Yuan Li, Meng-Lan Ge, Ai-Ping Deng   +4 more
semanticscholar   +1 more source