Adverse event reporting of faricimab: a disproportionality analysis of FDA adverse event reporting system (FAERS) database [PDF]
Frontiers in PharmacologyBackgroundFaricimab is the first and only bispecific antibody approved by the U.S. Food and Drug Administration (FDA) for intravitreal injection. Given its increasingly widespread use in retinal vascular diseases, understanding its adverse events (AEs ...
Chang-Zhu He +5 more
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Adverse event profile of lorazepam: a real-world pharmacovigilance study using the FDA adverse event reporting system database [PDF]
Frontiers in PharmacologyIntroductionAnxiety diagnoses have surged recently during and after the COVID-19 pandemic. Lorazepam is widely recognized for its efficacy in treatment of anxiety, as well as insomnia, etc.
Zhengkang Su +4 more
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Adverse event signal mining and severe adverse event influencing factor analysis of Lumateperone based on FAERS database [PDF]
Frontiers in PharmacologyBackgroundLumateperone has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia in adults since 2019, however, there is still a lack of data report on adverse reactions in real-world settings.
Yanjing Zhang +12 more
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Age-stratified analysis of adverse event signals for clarithromycin: a disproportionality analysis using the FDA Adverse Event Reporting System [PDF]
Therapeutic Advances in Drug SafetyBackground: Clarithromycin is a widely used antibiotic, but its safety profile, particularly in different age groups, remains inadequately explored. Objectives: This study aims to characterize and illustrate the features of clarithromycin-related adverse
Haiyan Mai +4 more
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Safety assessment of sapropterin dihydrochloride: real-world adverse event analysis based on the FDA adverse event reporting system (FAERS) [PDF]
Frontiers in PharmacologyObjectiveSapropterin dihydrochloride is the first drug for the therapy of phenylketonuria, which is a rare disease that occurs one of 10,000–15,000 newborns.
Jiahong Zhong, Xihui Yu, Zhuomiao Lin
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Safety assessment of ripretinib: a real-world adverse event analysis from the food and drug administration adverse event reporting system [PDF]
Frontiers in OncologyBackgroundRipretinib has been approved for the treatment of gastrointestinal stromal tumors (GIST). As a novel therapy, several adverse reactions remain unidentified, necessitating a thorough safety evaluation.
Sentai Wang +4 more
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Adverse event profiles of CDK4/6 inhibitors: data mining and disproportionality analysis of the FDA adverse event reporting system [PDF]
Therapeutic Advances in Drug SafetyBackground: Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors are targeted therapies designed to selectively block CDK4/6, crucial regulators of the cell cycle.
Jun Shen, Pingli Luo, Jianmei Xu
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Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea [PDF]
Clinical and Experimental Pediatrics, 2023 As of June 2022, 5 coronavirus disease 2019 (COVID-19) vaccine brands have been used in Korea’s national immunization program. The Korea Disease Control and Prevention Agency has enhanced vaccine safety monitoring through a passive web-based reporting ...
Yeon-Kyeng Lee +10 more
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COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021 [PDF]
Osong Public Health and Research Perspectives, 2021 Objectives On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and ...
Hyun-kyung Oh +6 more
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Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea [PDF]
Epidemiology and Health, 2022 OBJECTIVES In Korea, a national coronavirus disease 2019 (COVID-19) vaccination program was implemented, including 4 vaccines against COVID-19. A text messaging-based survey, in addition to a passive adverse event reporting system, was launched to ...
Yunhyung Kwon +7 more
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