The US National Child Death Review Case Reporting System

2011 ◽  
Vol 17 (Suppl I) ◽  
pp. i34-i37 ◽  
Author(s):  
T. M. Covington
Keyword(s):  
Reporting System ◽  
Child Death ◽  
Child Death Review ◽  
The Us

scholarly journals Cause-specific mortality among children and young adults with epilepsy: Results from the U.S. National Child Death Review Case Reporting System

2015 ◽  
Vol 45 ◽  
pp. 31-34 ◽  
Author(s):  
Niu Tian ◽  
Esther C. Shaw ◽  
Matthew Zack ◽  
Rosemarie Kobau ◽  
Heather Dykstra ◽  
...  
Keyword(s):  
Young Adults ◽  
Reporting System ◽  
Child Death ◽  
Child Death Review ◽  
Specific Mortality ◽  
Children And Young Adults ◽  
The U.S

Mental Health and Psychosocial Issues in Pediatric Suicide – Review of the National Child Death Case Reporting System

PEDIATRICS ◽  
2016 ◽  
Vol 137 (Supplement 3) ◽  
pp. 42A-42A ◽  
Author(s):  
Theodore Trigylidas ◽  
Eliza Reynolds ◽  
Getachew Teshome ◽  
Heather Dykstra ◽  
Richard Lichenstein
Keyword(s):  
Mental Health ◽  
Reporting System ◽  
Child Death ◽  
Psychosocial Issues ◽  
Death Case

scholarly journals Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS)

2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  
Keyword(s):  
Adverse Event ◽  
Drug Administration ◽  
Cardiovascular Events ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Cardiovascular Safety ◽  
Event Reporting ◽  
The Us

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.

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