scholarly journals The Irony of MedWatch and the FAERS Database: An Assessment of Data Input Errors and Potential Consequences

2020 ◽  
Vol 36 (4) ◽  
pp. 164-167
Author(s):  
Michael A. Veronin ◽  
Robert P. Schumaker ◽  
Rohit Dixit

Health care delivery revolves around accurate documentation, with data management free from error. A seemingly insignificant typographical error can cause short- and long-term problems that may lead to inaccurate records and misinformation. This report presents an overview of input errors in the US Food and Drug Administration Adverse Event Reporting System (FAERS). The focus is on errors and inconsistencies in reporting of drug names in the FAERS database, initiated through input of the MedWatch reporting system. The consequences from erroneous data input—in this case, drug names—can have an impact on data integrity, research, and patient safety.

2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  

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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