An Examination of Mortality and Other Adverse Events Related to Electroconvulsive Therapy Using a National Adverse Event Report System

2011 ◽  
Vol 27 (2) ◽  
pp. 105-108 ◽  
Author(s):  
Bradley V. Watts ◽  
Alicia Groft ◽  
James P. Bagian ◽  
Peter D. Mills
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Electroconvulsive Therapy ◽  
Adverse Event Report ◽  
Event Report ◽  
Report System

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.

scholarly journals Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

2020 ◽  
Vol 84 (9) ◽  
pp. 1568-1574 ◽  
Author(s):  
Yoshiaki Mitsutake ◽  
Akihide Konishi ◽  
Nobuhiro Handa ◽  
Mami Ho ◽  
Haruki Shirato ◽  
...  
Keyword(s):  
Adverse Event ◽  
Stent Thrombosis ◽  
Drug Eluting Stent ◽  
Hospital Death ◽  
Adverse Event Report ◽  
Event Report ◽  
Report System ◽  
Drug Eluting

Cognition- and Dementia-Related Adverse Effects With Sacubitril-Valsartan: Analysis of the FDA Adverse Event Report System Database

2018 ◽  
Vol 24 (8) ◽  
pp. 533-536 ◽  
Author(s):  
Amichai Perlman ◽  
Bruria Hirsh Raccah ◽  
Ilan Matok ◽  
Mordechai Muszkat
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Event Report ◽  
Event Report ◽  
System Database ◽  
Report System

Dietary Supplement Adverse Event Report Data From the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013

2017 ◽  
Vol 52 (5) ◽  
pp. 431-438 ◽  
Author(s):  
Babgaleh B. Timbo ◽  
Stuart J. Chirtel ◽  
John Ihrie ◽  
Taiye Oladipo ◽  
Loy Velez-Suarez ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Adverse Event Reporting ◽  
Reporting Rate ◽  
Adverse Event Report ◽  
Event Report ◽  
Consumer Protection Act ◽  
Nonprescription Drug

Background: The Food and Drug Administration (FDA)’s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety of the nation’s foods, dietary supplements, and cosmetic products. Objective: To present a descriptive analysis of the 2004-2013 dietary supplement adverse event report (AER) data from CAERS and evaluate the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act as pertaining to dietary supplements adverse events reporting. Methods: We queried CAERS for data from the 2004-2013 AERs specifying at least 1 suspected dietary supplement product. We extracted the product name(s), the symptom(s) reported, age, sex, and serious adverse event outcomes. We examined time trends for mandatory and voluntary reporting and performed analysis using SAS v9.4 and R v3.3.0 software. Results: Of the total AERs (n = 15 430) received from January 1, 2004, through December 31, 2013, indicating at least 1 suspected dietary supplement product, 66.9% were mandatory, 32.2% were voluntary, and 0.9% were both mandatory and voluntary. Reported serious outcomes included death, life-threatening conditions, hospitalizations, congenital anomalies/birth defects and events requiring interventions to prevent permanent impairments (5.1%). The dietary supplement adverse event reporting rate in the United States was estimated at ~2% based on CAERS data. Conclusions: This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 period and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

Sign in / Sign up

Export Citation Format

Share Document