Association rule mining in the US Vaccine Adverse Event Reporting System (VAERS)

2015 ◽  
Vol 24 (9) ◽  
pp. 922-933 ◽  
Author(s):  
Lai Wei ◽  
John Scott
Keyword(s):  
Adverse Event ◽  
Association Rule ◽  
Association Rule Mining ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Rule Mining ◽  
Event Reporting ◽  
The Us

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.

scholarly journals Complementing the US Food and Drug Administration Adverse Event Reporting System With Adverse Drug Reaction Reporting From Social Media: Comparative Analysis (Preprint)

2020 ◽  
Author(s):  
Zeyun Zhou ◽  
Kyle Emerson Hultgren
Keyword(s):  
Social Media ◽  
Adverse Event ◽  
Drug Administration ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Twitter Data ◽  
The Us

BACKGROUND Adverse drug reactions (ADRs) can occur any time someone uses a medication. ADRs are systematically tracked and cataloged, with varying degrees of success, in order to better understand their etiology and develop methods of prevention. The US Food and Drug Administration (FDA) has developed the FDA Adverse Event Reporting System (FAERS) for this purpose. FAERS collects information from myriad sources, but the primary reporters have traditionally been medical professionals and pharmacovigilance data from manufacturers. Recent studies suggest that information shared publicly on social media platforms related to medication use could be of benefit in complementing FAERS data in order to have a richer picture of how medications are actually being used and the experiences people are having across large populations. OBJECTIVE The aim of this study is to validate the accuracy and precision of social media methodology and conduct evaluations of Twitter ADR reporting for commonly used pharmaceutical agents. METHODS ADR data from the 10 most prescribed medications according to pharmacy claims data were collected from both FAERS and Twitter. In order to obtain data from FAERS, the SafeRx database, a curated collection of FAERS data, was used to collect data from March 1, 2016, to March 31, 2017. Twitter data were manually scraped during the same time period to extract similar data using an algorithm designed to minimize noise and false signals in social media data. RESULTS A total of 40,539 FAERS ADR reports were obtained via SafeRx and more than 40,000 tweets containing the drug names were obtained from Twitter’s Advanced Search engine. While the FAERS data were specific to ADRs, the Twitter data were more limited. Only hydrocodone/acetaminophen, prednisone, amoxicillin, gabapentin, and metformin had a sufficient volume of ADR content for review and comparison. For metformin, diarrhea was the side effect that resulted in no difference between the two platforms (<i>P</i>=.30). For hydrocodone/acetaminophen, ineffectiveness as an ADR that resulted in no difference (<i>P</i>=.60). For gabapentin, there were no differences in terms of the ADRs ineffectiveness and fatigue (<i>P</i>=.15 and <i>P=</i>.67, respectively). For amoxicillin, hypersensitivity, nausea, and rash shared similar profiles between platforms (<i>P</i>=.35, <i>P=</i>.05, and <i>P=</i>.31, respectively). CONCLUSIONS FAERS and Twitter shared similarities in types of data reported and a few unique items to each data set as well. The use of Twitter as an ADR pharmacovigilance platform should continue to be studied as a unique and complementary source of information rather than a validation tool of existing ADR databases.

Sign in / Sign up

Export Citation Format

Share Document