scholarly journals The FDA Drug Safety Surveillance Program: Adverse Event Reporting Trends

2011 ◽  
Vol 171 (6) ◽  
pp. 591 ◽  
Author(s):  
Sheila Weiss-Smith
Keyword(s):  
Adverse Event ◽  
Drug Safety ◽  
Adverse Event Reporting ◽  
Surveillance Program ◽  
Event Reporting ◽  
Safety Surveillance ◽  
Drug Safety Surveillance

scholarly journals Estimated Incidence of Sugammadex-Induced Anaphylaxis Using the Korea Adverse Event Reporting System Database

2021 ◽  
Vol 10 (15) ◽  
pp. 3202
Author(s):  
Jae-Woo Ju ◽  
Nayoung Kim ◽  
Seong Mi Yang ◽  
Won Ho Kim ◽  
Ho-Jin Lee
Keyword(s):  
Risk Management ◽  
Adverse Event ◽  
General Anesthesia ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sales Volume ◽  
Event Reporting ◽  
Pharmacovigilance Database

We aimed to investigate the incidence of sugammadex-induced anaphylaxis in a large Korean population. We retrospectively investigated the incidence of sugammadex-induced anaphylaxis between 2013 and 2019 from the database of the Korea Institute of Drug Safety-Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS). We estimated the incidence of sugammadex-induced anaphylaxis from the KIDS-KAERS database, assuming that the reporting efficiency was 10%, 50%, and 100%, respectively. We also investigated its annual sales volume in Korea and assumed that the exposure to sugammadex was 95% of the estimated sales volume. During the study period, 1,401,630 sugammadex vials were sold, and 19 cases of sugammadex-induced anaphylaxis were identified in the KIDS-KAERS database. The estimated incidence of sugammadex-induced anaphylaxis was 0.0143%, 0.00279%, and 0.0014%, assuming a reporting efficiency of 10%, 50%, and 100%, respectively. All patients, except for one with a missing record, fully recovered after anaphylaxis. The incidence of sugammadex-induced anaphylaxis identified in the national pharmacovigilance database was lower than previously reported rates in other countries. Therefore, its use in general anesthesia should not be hindered by concerns about the resulting risk of anaphylaxis in Korea.

A Primer of Drug Safety Surveillance: An Industry Perspective

1992 ◽  
Vol 8 (4) ◽  
pp. 162-167
Author(s):  
Marjorie C. Allan
Keyword(s):  
Adverse Event ◽  
Drug Safety ◽  
Adverse Drug Event ◽  
Drug Event ◽  
Event Data ◽  
The Public ◽  
Safety Surveillance ◽  
Pharmaceutical Manufacturers ◽  
Drug Safety Surveillance ◽  
Clinical Drug

Objective: To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. Data Sources: This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. Study Selection: The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. Data Synthesis: The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse event data for various audiences. Conclusions: Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of the manufacturer. Attention to basic principles is essential and, as illustrated, may be sufficient to resolve some problems.

scholarly journals 2296. Hypoglycemia Risk with Antibiotics: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S787-S787
Author(s):  
Kaitlin E Kennedy ◽  
Chengwen Teng ◽  
Taylor M Patek ◽  
Christopher R Frei
Keyword(s):  
Adverse Event ◽  
Drug Safety ◽  
Potential Risk ◽  
Case Reports ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Epidemiologic Surveillance ◽  
Safety Warning ◽  
Medical Dictionary

Abstract Background In July of 2018, the FDA published a drug safety warning for the potential risk of developing hypoglycemia with fluoroquinolones. Some studies have evaluated the potential risk of developing hypoglycemia with linezolid and tigecycline. A few case reports have also been published that report hypoglycemia from cefditoren, doxycycline, and trimethoprim-sulfamethoxazole use. Since data comparing various antibiotics and the risk of developing hypoglycemia is limited, the objective of this study was to evaluate the association between hypoglycemia and antibiotics using the FDA Adverse Event Reporting Systems (FAERS). Methods FAERS reports from January 1, 2004 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hypoglycemia. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and hypoglycemia were calculated. An association was considered to be statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 2,334,959 reports (including 18,466 hypoglycemia reports) were considered, after inclusion criteria were applied. Cefditoren had the greatest proportion of hypoglycemia reports, representing 10% of all cefditoren reports. Statistically significant hypoglycemia RORs (95% CI) for antibiotics were: cefditoren 14.03 (8.93–22.03), tigecycline 3.32 (1.95–5.65), clarithromycin 2.41 (1.89–3.08), ertapenem 2.07 (1.14–3.75), moxifloxacin 2.06 (1.59–2.65), levofloxacin 1.66 (1.37–2.01), linezolid 1.54 (1.07–2.20). Conclusion Cefditoren, tigecycline, clarithromycin, ertapenem, moxifloxacin, levofloxacin, and linezolid were all significantly associated with hypoglycemia. The ertapenem association had not been reported in prior literature. Levofloxacin and moxifloxacin were the only fluoroquinolones significantly associated with hypoglycemia, even though the FDA drug safety warning was issued for all fluoroquinolones. Doxycycline and trimethoprim-sulfamethoxazole were not significantly associated with hypoglycemia, even though case reports have reported hypoglycemia with doxycycline and trimethoprim-sulfamethoxazole. Disclosures All authors: No reported disclosures.

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