scholarly journals Safety of SGLT2 Inhibitors: A Pharmacovigilance Study From 2015 to 2020 Based on FDA Adverse Event Report System Database

2021 ◽  
Author(s):  
Xiang Zhou ◽  
Xiaofei Ye ◽  
Yinghong Zhai ◽  
Fangyuan Hu ◽  
Yongqing Gao ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Diabetic Ketoacidosis ◽  
Adverse Event Reporting System ◽  
Kidney Injury ◽  
Adverse Event Reporting ◽  
Adverse Event Report ◽  
System Database ◽  
Report System ◽  
Euglycemic Diabetic Ketoacidosis

Aim: With the widespread use of SGLT2i, various adverse events (AEs) have been reported. This study aimed to describe the distribution of SGLT2i-related AEs in different systems, quantify the association of important medical events (IMEs) and SGLT2i regimens, and build a signal profile of SGLT2i- induced IMEs. Methods: Data from 2015 Q1 to 2020 Q4 in the FDA Adverse Event Reporting System database (FAERS) were selected to conduct disproportionality analysis. Two signal indicators, the reported odds ratio (ROR) and information component (IC), were used to evaluate the correlation between SGLT2i and IMEs. The lower end of the 95% confidence interval of IC (IC025) exceeding zero was deemed a signal. For ROR, it was defined a signal if ROR025 over one, with at least 3 cases. Results: A total of 45,771,436 records were involved, including 111,564 records related to SGLT2i, with 38,366 records of SGLT2i-induced IMEs. Overall, SGLT2i was significantly associated with IMEs (IC=0.36, 95% CI: 0.35-0.38; ROR=1.44, 95% CI: 1.42-1.46). Most SGLT2i-related adverse events occurred in monotherapy (92.93%). Diabetic ketoacidosis was the most IMEs. Specifically, acute osteomyelitis has the strongest signal of all SGLT2i (IC025=7.83), and it was unique to canagliflozin. Diabetic ketoacidosis, acute kidney injury, ketoacidosis, Fournier’s gangrene, and euglycemic diabetic ketoacidosis were common to the four FDA-approved SGLT2i. Conclusion: Our study demonstrated that different SGLT2i regimens lead to different important adverse events, but there are overlapping events. Early identification and management of SGLT2i-associated IMEs are essential for clinical practice.

Novel Adverse Events of Bevacizumab in the US FDA Adverse Event Reporting System Database

Drug Safety ◽  
2012 ◽  
Vol 35 (6) ◽  
pp. 507-518 ◽  
Author(s):  
Behrooz K. Shamloo ◽  
Pankdeep Chhabra ◽  
Andrew N. Freedman ◽  
Arnold Potosky ◽  
Jennifer Malin ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
System Database ◽  
The Us ◽  
Us Fda

Application of FDA Adverse Event Report Data to the Surveillance of Dietary Botanical Supplements

2008 ◽  
Vol 42 (5) ◽  
pp. 653-660 ◽  
Author(s):  
Robert B Wallace ◽  
Brian M Gryzlak ◽  
M Bridget Zimmerman ◽  
Nicole L Nisly
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Product Information ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Adverse Event Report ◽  
St John’S Wort ◽  
St John's Wort ◽  
Botanical Supplements

Background: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects. Objective: To characterize data on DBSs associated with adverse event reports submitted to CAERS. Methods: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. Results: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. Conclusions: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.

scholarly journals 3542 Torsade de pointes/QT prolongation risks with antibiotics: A contemporary analysis of the FDA Adverse Event Reporting System

2019 ◽  
Vol 3 (s1) ◽  
pp. 57-57
Author(s):  
Chengwen Teng ◽  
Daryl Kevin S. Gaspar ◽  
Christopher Frei
Keyword(s):  
Adverse Event ◽  
Adverse Event Reporting System ◽  
Torsade De Pointes ◽  
Adverse Event Reporting ◽  
Qt Prolongation ◽  
Adverse Event Report ◽  
Report System ◽  
Study Population ◽  
Medical Dictionary ◽  
New Evidence

OBJECTIVES/SPECIFIC AIMS: Macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone are known to be associated with Torsade de pointes/QT prolongation (TdP/QTP). Other antibiotics may also lead to TdP/QTP, but no study has systemically compared TdP/QTP risks of different antibiotics using recent data. Therefore, the objective of this study was to evaluate the association between TdP/QTP and antibiotics in recent years using the FDA Adverse Event Report System (FAERS). METHODS/STUDY POPULATION: FAERS reports from January 1, 2015 to December 31, 2017 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify TdP/QTP cases. We calculated the Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95%CI) for the association between antibiotics and TdP/QTP. An association was considered to be statistically significant when the lower limit of the 95%CI was greater than 1. RESULTS/ANTICIPATED RESULTS: A total of 2,042,801 reports (including 5,221 TdP/QTP reports) were considered, after inclusion criteria were applied. Macrolides had the greatest proportion of TdP/QTP reports, representing 2.9% of all macrolide reports. TdP/QTP RORs (95%CI) for the antibiotics were (in descending order): macrolides 11.73 (9.74-14.12), linezolid 9.39 (6.45-13.68), amikacin 8.94 (4.22-18.92), imipenem-cilastatin 5.01 (2.38-10.56), fluoroquinolones 4.67 (3.96-5.52), penicillin combinations 3.52 (2.56-4.86), cephalosporins 1.90 (1.14-3.16), metronidazole 1.49 (0.74-2.99), vancomycin 1.26 (0.70-2.28), clindamycin 0.83 (0.27-2.58), trimethoprim-sulfamethoxazole 0.82 (0.31-2.18), and amoxicillin 0.57 (0.18-1.78). DISCUSSION/SIGNIFICANCE OF IMPACT: This study confirms prior evidence for TdP-QTP risks with macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and cephalosporins. This study provides new evidence for TdP-QTP risks with amikacin. Macrolides had the highest TdP/QTP ROR among the antibiotics evaluated in this study.

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