Bisphosphonates and esophageal cancer: A RADAR report.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4063-4063
Author(s):  
Beatrice J. Edwards ◽  
Beatrice Nardone ◽  
Dennis W Raisch ◽  
June M. Mckoy ◽  
Steven M Belknap ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Adverse Event ◽  
Barrett’S Esophagus ◽  
Barrett's Esophagus ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Safety Signal ◽  
Event Reporting ◽  
Significant Safety

4063 Background: In 2009, the US Food and Drug Administration (FDA) reported on 23 patients who had developed distal esophageal cancer, with alendronate (ALN) within 2 years of initiation of therapy. Similarly, 31 cases of esophageal cancer were reported from Europe and Japan. Esophagitis has been associated with oral BPs. Erosive esophagitis and persistent mucosal abnormalities have been noted with crystalline material (similar to ground ALN). Our objective was to assess the FDA Adverse event reporting system (FDA AERS) for a safety signal. Methods: The FDA Adverse Event Reporting System (AERS) database was searched using terms related to esophageal cancer combined with all drug names for bisphosphonates (search period:1996-2010). Disproportionality ratios were calculated: Proportional reporting ratio (PRR) and Empiric Bayes Geometric Mean (EBGM) determining that the esophageal cancer cases were more common with bisphosphonates than with other drugs in the database. Results: We identified 128 cases of bisphosphonate-associated esophageal cancer; 114 (89%) female and 14 male (11%), mean age 72 ± 12 yrs; the drugs included alendronate (n=96, 75%), risedronate sodium (n=14, 11%), ibandronic acid (n=10, 7.8%), zoledronic acid (n=7, 5.4%) and pamidronate (n=1, 1%). Barrett’s esophagus was listed in 3 cases of esophageal carcinoma. A significant safety signal was found only for alendronate with a PRR= 6.4 (95% C.I. 5.29, 7.730; p=0.001), EBGM = 6.3 (95% C.I. 5.1, 7.6 p=0.001). Conclusions: Our analysis of FDA AERS identifies a larger number of cases of esophageal cancer than previously described, and a significant safety signal with alendronate use. Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, and persistent mucosal abnormalities is recommended. Increased awareness and vigilance is needed for patients receiving oral bisphosphonate therapy.

scholarly journals Combining big data search analytics and the FDA Adverse Event Reporting System database to detect a potential safety signal of mirtazapine abuse

2020 ◽  
Vol 26 (3) ◽  
pp. 2265-2279 ◽  
Author(s):  
Dimitrios Spachos ◽  
Spyridon Siafis ◽  
Panagiotis Bamidis ◽  
Dimitrios Kouvelas ◽  
Georgios Papazisis
Keyword(s):  
Adverse Event ◽  
Odds Ratio ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Safety Signal ◽  
Event Reporting ◽  
System Database ◽  
Potential Safety ◽  
Different Sources

This study sought to detect a potential safety signal of mirtazapine abuse by combining two different sources of surveillance, specifically Google Analytics (Google, Inc., Mountain View, CA, USA) and the FDA Adverse Event Reporting System database. Data from the first quarter of 2004 to the second quarter of 2017 were collected and analysed. The search interest over time, the frequencies of abuse-related terms in the search analytics domain, and the odds ratio of abuse events in FDA Adverse Event Reporting System were determined. Correlations between the two aforementioned domains using quarterly data from the timeline series were also assessed. Our results suggest a positive correlation between abuse-related searches in the Google domain and abuse-related events in FDA Adverse Event Reporting System database. These results indicate that these methods can be used in combination with each other as a pharmacovigilance supplementary tool to detect drug safety signals.

scholarly journals Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaojiang Tian ◽  
Yao Yao ◽  
Guanglin He ◽  
Yuntao Jia ◽  
Kejing Wang ◽  
...  
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Reporting System ◽  
Proportional Reporting Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Systematic Analysis ◽  
Event Reporting ◽  
Exfoliative Dermatitis

AbstractThis current investigation was aimed to generate signals for adverse events (AEs) of darunavir-containing agents by data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS). All AE reports for darunavir, darunavir/ritonavir, or darunavir/cobicistat between July 2006 and December 2019 were identified. The reporting Odds Ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) were used to detect the risk signals. A suspicious signal was generated only if the results of the three algorithms were all positive. A total of 10,756 reports were identified commonly observed in hepatobiliary, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutrition system. 40 suspicious signals were generated, and therein 20 signals were not included in the label. Severe high signals (i.e. progressive extraocular muscle paralysis, acute pancreatitis, exfoliative dermatitis, acquired lipodystrophy and mitochondrial toxicity) were identified. In pregnant women, umbilical cord abnormality, fetal growth restriction, low birth weight, stillbirth, premature rupture of membranes, premature birth and spontaneous abortion showed positive signals. Darunavir and its boosted agents induced AEs in various organs/tissues, and were shown to be possibly associated with multiple adverse pregnant conditions. This study highlighted some novel and severe AEs of darunavir which need to be monitored prospectively.

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 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.

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