Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study
CONCLUSIONS: Clinicians should be aware of the potential for ICI-associated myositis, as it can be particularly life-threatening, especially in elderly patients or when it occurs concurrently with other AEs such as myocarditis or severe myasthenia gravis.PMID:38629402 | DOI:10.1080/14740338.2024.2343023 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 17, 2024 Category: Drugs & Pharmacology Authors: Hezhe Lu Hui Yang Zhexin Ding Zhuoling An Yong Zhao Source Type: research
Overview of U.S. COVID-19 vaccine safety surveillance systems
This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccin...
Source: Vaccine - April 17, 2024 Category: Allergy & Immunology Authors: Julianne Gee Tom T Shimabukuro John R Su David Shay Margaret Ryan Sridhar V Basavaraju Karen R Broder Matthew Clark C Buddy Creech Francesca Cunningham Kristin Goddard Harrison Guy Kathryn M Edwards Richard Forshee Tanya Hamburger Anne M Hause Nicola P Kl Source Type: research
Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study
CONCLUSIONS: Clinicians should be aware of the potential for ICI-associated myositis, as it can be particularly life-threatening, especially in elderly patients or when it occurs concurrently with other AEs such as myocarditis or severe myasthenia gravis.PMID:38629402 | DOI:10.1080/14740338.2024.2343023 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 17, 2024 Category: Drugs & Pharmacology Authors: Hezhe Lu Hui Yang Zhexin Ding Zhuoling An Yong Zhao Source Type: research
Overview of U.S. COVID-19 vaccine safety surveillance systems
This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccin...
Source: Vaccine - April 17, 2024 Category: Allergy & Immunology Authors: Julianne Gee Tom T Shimabukuro John R Su David Shay Margaret Ryan Sridhar V Basavaraju Karen R Broder Matthew Clark C Buddy Creech Francesca Cunningham Kristin Goddard Harrison Guy Kathryn M Edwards Richard Forshee Tanya Hamburger Anne M Hause Nicola P Kl Source Type: research
Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study
CONCLUSIONS: Clinicians must note the risk of ICI-associated myositis, especially dangerous in older patients or when combined with other issues like myocarditis or severe myasthenia gravis.PMID:38629402 | DOI:10.1080/14740338.2024.2343023 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 17, 2024 Category: Drugs & Pharmacology Authors: Hui Yang Zhexin Ding Zhuoling An Yong Zhao Hezhe Lu Source Type: research
Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib: a real-world pharmacovigilance study
ConclusionOur findings contribute to the selection and clinical management of NIVO-IPI and NIVO-CABO, which minimizes the risk of AEs for individual patients with mRCC by considering distinctive differences in the AE profiles. (Source: International Journal of Clinical Pharmacy)
Source: International Journal of Clinical Pharmacy - April 17, 2024 Category: Drugs & Pharmacology Source Type: research
Imaging associations enhance the understanding of ECG abnormalities in male Brazilian football players: findings from the B-Pro Foot ECG study
CONCLUSION: This study found a 3% prevalence of abnormal ECGs in male Brazilian football players. Inferolateral TWI was associated with cardiac pathologies confirmed by CMR, even in athletes with a normal TTE.PMID:38621858 | DOI:10.1136/bjsports-2023-108053 (Source: British Journal of Sports Medicine)
Source: British Journal of Sports Medicine - April 15, 2024 Category: Sports Medicine Authors: Filipe Ferrari Anderson D da Silveira Patr ícia K Ziegelmann Haroldo Aleixo Guilherme D Dilda Luiz G M Emed Fl ávia C O Magalhães Fernando B Cardoso Henrique C da Silva Felipe E F Guerra Luciano G Soares Fernando Bassan Fabr ício Braga Artur H Herdy V Source Type: research
Imaging associations enhance the understanding of ECG abnormalities in male Brazilian football players: findings from the B-Pro Foot ECG study
CONCLUSION: This study found a 3% prevalence of abnormal ECGs in male Brazilian football players. Inferolateral TWI was associated with cardiac pathologies confirmed by CMR, even in athletes with a normal TTE.PMID:38621858 | DOI:10.1136/bjsports-2023-108053 (Source: British Journal of Sports Medicine)
Source: British Journal of Sports Medicine - April 15, 2024 Category: Sports Medicine Authors: Filipe Ferrari Anderson D da Silveira Patr ícia K Ziegelmann Haroldo Aleixo Guilherme D Dilda Luiz G M Emed Fl ávia C O Magalhães Fernando B Cardoso Henrique C da Silva Felipe E F Guerra Luciano G Soares Fernando Bassan Fabr ício Braga Artur H Herdy V Source Type: research
Imaging associations enhance the understanding of ECG abnormalities in male Brazilian football players: findings from the B-Pro Foot ECG study
CONCLUSION: This study found a 3% prevalence of abnormal ECGs in male Brazilian football players. Inferolateral TWI was associated with cardiac pathologies confirmed by CMR, even in athletes with a normal TTE.PMID:38621858 | DOI:10.1136/bjsports-2023-108053 (Source: British Journal of Sports Medicine)
Source: British Journal of Sports Medicine - April 15, 2024 Category: Sports Medicine Authors: Filipe Ferrari Anderson D da Silveira Patr ícia K Ziegelmann Haroldo Aleixo Guilherme D Dilda Luiz G M Emed Fl ávia C O Magalhães Fernando B Cardoso Henrique C da Silva Felipe E F Guerra Luciano G Soares Fernando Bassan Fabr ício Braga Artur H Herdy V Source Type: research
Comparative safety profile of bivalent and original COVID-19 mRNA vaccines regarding myocarditis/pericarditis: A pharmacovigilance study
CONCLUSION: This population-based study provides evidence that bivalent COVID-19 mRNA vaccination is not associated with risk of myocarditis/pericarditis. These findings provide important insights into the safety profile of bivalent COVID-19 mRNA vaccines and support their continued use as updated boosters.PMID:38615382 | DOI:10.1016/j.intimp.2024.112022 (Source: International Immunopharmacology)
Source: International Immunopharmacology - April 14, 2024 Category: Allergy & Immunology Authors: Congqin Chen Chunmei Chen Longxing Cao Jie Fang Jie Xiao Source Type: research
Comparative safety profile of bivalent and original COVID-19 mRNA vaccines regarding myocarditis/pericarditis: A pharmacovigilance study
CONCLUSION: This population-based study provides evidence that bivalent COVID-19 mRNA vaccination is not associated with risk of myocarditis/pericarditis. These findings provide important insights into the safety profile of bivalent COVID-19 mRNA vaccines and support their continued use as updated boosters.PMID:38615382 | DOI:10.1016/j.intimp.2024.112022 (Source: International Immunopharmacology)
Source: International Immunopharmacology - April 14, 2024 Category: Allergy & Immunology Authors: Congqin Chen Chunmei Chen Longxing Cao Jie Fang Jie Xiao Source Type: research
Analysis of mild and severe neonatal enterovirus infections in a Chinese neonatal tertiary center: a retrospective case-control study
ConclusionWe found significant differences between mild and severe cases of neonatal enterovirus infection with respect to complications, laboratory findings, and enterovirus serotypes. It is crucial to exercise caution when newborns exhibit symptoms of sepsis, during an enterovirus outbreak. Anemia, thrombocytopenia, abnormal liver function, and coagulation dysfunction should be monitored closely as they could indicate the presence of a severe enteroviral infection. (Source: European Journal of Clinical Microbiology and Infectious Diseases)
Source: European Journal of Clinical Microbiology and Infectious Diseases - April 12, 2024 Category: Microbiology Source Type: research
Characterization of Brighton Collaboration criteria for myocarditis and pericarditis following COVID-19 vaccine in Korean adolescents
CONCLUSION: The Brighton Collaboration case definition proved valuable for classifying and assessing AEFI data, enhancing our understanding of the potential relationship between myocarditis and the COVID-19 vaccine.PMID:38604914 | DOI:10.1016/j.vaccine.2024.04.032 (Source: Vaccine)
Source: Vaccine - April 11, 2024 Category: Allergy & Immunology Authors: Jue Seong Lee HyoSug Choi Seung Hwan Shin Myung-Jae Hwang Sara Na Jong Hee Kim Sangshin Park Yoonsun Yoon Hyun Mi Kang Bin Ahn Kyoungsan Seo Young June Choe Source Type: research
Assessment of Risk for Sudden Cardiac Death Among Adolescents and Young Adults After Receipt of COVID-19 Vaccine - Oregon, June 2021-December 2022
MMWR Morb Mortal Wkly Rep. 2024 Apr 11;73(14):317-320. doi: 10.15585/mmwr.mm7314a5.ABSTRACTCOVID-19 vaccination has been associated with myocarditis in adolescents and young adults, and concerns have been raised about possible vaccine-related cardiac fatalities in this age group. In April 2021, cases of myocarditis after COVID-19 vaccination, particularly among young male vaccine recipients, were reported to the Vaccine Adverse Event Reporting System. To assess this possibility, investigators searched death certificates for Oregon residents aged 16-30 years who died during June 2021-December 2022 for cardiac or undetermine...
Source: MMWR Morb Mortal Wkl... - April 11, 2024 Category: Epidemiology Authors: Juventila Liko Paul R Cieslak Source Type: research
