scholarly journals Cardiac Events Potentially Associated to Remdesivir: An Analysis from the European Spontaneous Adverse Event Reporting System

2021 ◽  
Vol 14 (7) ◽  
pp. 611
Author(s):  
Concetta Rafaniello ◽  
Carmen Ferrajolo ◽  
Maria Giuseppa Sullo ◽  
Mario Gaio ◽  
Alessia Zinzi ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Event Reporting System ◽  
Fatal Outcome ◽  
Individual Case ◽  
Adverse Event Reporting ◽  
European Medicines Agency ◽  
Cardiac Events ◽  
Potential Safety ◽  
Increased Risk ◽  
Pharmacovigilance Risk Assessment Committee

Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hepatic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (±2.2). Finally, disproportionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings.

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 1977. Comparing Acute Kidney Injury Risk among Antibiotic Classes: A Study of the FDA Adverse Event Reporting System (FAERS)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S662-S662
Author(s):  
Taylor M Patek ◽  
Chengwen Teng ◽  
Kaitlin E Kennedy ◽  
Christopher R Frei
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Event ◽  
Injury Risk ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Kidney Injury ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Event Reporting ◽  
Increased Risk

Abstract Background A recent article published in 2018 studied the FDA Adverse Event Reporting System (FAERS) and listed the most common medications associated with acute kidney injury (AKI) based on number of AKI reports. In regards to antibiotics, the study only ranked vancomycin, fluoroquinolones, penicillin combinations, and trimethoprim–sulfamethoxazole as having a significant association with AKI. The objective of this study was to evaluate those and additional antibiotic classes using FAERS, and to compare their risk associated with this adverse drug event. Methods FAERS reports from January 1, 2015 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify AKI cases. Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and AKI were calculated. An association was considered statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 2,042,801 reports (including 20,138 acute kidney injury reports) were considered, after inclusion criteria were applied. Colistin had the greatest proportion of AKI reports, representing 25% of all colistin reports. Acute kidney injury RORs (95% CI) for antibiotics were (in descending order): colistin 33.10 (21.24–51.56), aminoglycosides 17.41 (14.49–20.90), vancomycin 15.28 (13.82–16.90), trimethoprim-sulfamethoxazole 13.72 (11.94–15.76), penicillin combinations 7.95 (7.09–8.91), clindamycin 6.46 (5.18–8.04), cephalosporins 6.07 (5.23–7.05), daptomycin 6.07 (4.61–7.99), macrolides 3.60 (3.04–4.26), linezolid 3.48 (2.54–4.77), carbapenems 3.31 (2.58–4.25), metronidazole 2.55 (1.94–3.36), tetracyclines 1.73 (1.26–2.36), and fluoroquinolones 1.71 (1.49–1.97). Conclusion This study found 17 classes of antibiotics and combinations that were significantly associated with AKI compared with four antibiotics that were mentioned in a recently published article looking at drug-associated AKI. While this study confirmed previous literature of certain antibiotics associated with increased risk of AKI, it also compared antibiotics within classes and provided additional insight regarding which antibiotics had the highest associated risk of an AKI. Disclosures All authors: No reported disclosures.

scholarly journals A Computational Framework for Identifying Age Risks in Drug-Adverse Event Pairs

2022 ◽  
Author(s):  
Zhizhen Zhao ◽  
Ruoqi Liu ◽  
Lei Wang ◽  
Lang Li ◽  
Chi Song ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Drug Events ◽  
Case Reports ◽  
Adverse Event Reporting System ◽  
Population Level ◽  
Individual Case ◽  
Risk Identification ◽  
Adverse Event Reporting ◽  
Computational Framework ◽  
Drug Adverse Event

The identification of associations between drugs and adverse drug events (ADEs) is crucial for drug safety surveillance. An increasing number of studies have revealed that children and seniors are susceptible to ADEs at the population level. However, the comprehensive explorations of age risks in drug-ADE pairs are still limited. The FDA Adverse Event Reporting System (FAERS) provides individual case reports, which can be used for quantifying different age risks. In this study, we developed a statistical computational framework to detect age group of patients who are susceptible to some ADEs after taking specific drugs. We adopted different Chi-squared tests and conducted disproportionality analysis to detect drug-ADE pairs with age differences. We analyzed 4,580,113 drug-ADE pairs in FAERS (2004 to 2018Q3) and identified 2,523 pairs with the highest age risk. Furthermore, we conducted a case study on statin-induced ADE in children and youth. The code and results are available at https://github.com/Zhizhen-Zhao/Age-Risk-Identification

scholarly journals Adverse Events During Pregnancy Associated With Entecavir and Adefovir: New Insights From a Real-World Analysis of Cases Reported to FDA Adverse Event Reporting System

2022 ◽  
Vol 12 ◽  
Author(s):  
Renjun Yang ◽  
Nuoya Yin ◽  
Ying Zhao ◽  
Dandan Li ◽  
Xuanling Zhang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Pregnant Women ◽  
Spontaneous Abortion ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Hbv Infection ◽  
Event Reporting ◽  
Strong Signal ◽  
Increased Risk

Background: Due to the embryotoxicity found in animal studies and scarce clinical data in pregnant women, it is still controversial whether entecavir (ETV) and adefovir dipivoxil (ADV) are safe during human pregnancy. This is of paramount importance when counseling pregnant women with hepatitis B virus (HBV) on risks and benefits to their offspring.Objective: To quantify the association between administration of ETV and ADV in pregnant women and occurrence of adverse events (AEs) during pregnancy (AEDP).Methods: Pregnancy reports from the FDA Adverse Event Reporting System (FAERS) were used to perform a retrospective analysis of AEDP associated with ETV or ADV. Disproportionality analysis estimating the reporting odds ratio (ROR) was conducted to identify the risk signals. A signal was defined as ROR value >2, and lower limit of 95% confidence interval (CI)> 1.Results: A total of 1,286,367 reports involving AEDP were submitted to FAERS by healthcare professionals. Of these, there were 547 cases reporting ETV and 242 cases reporting ADV as primary suspected drugs. We found a moderate or strong signal for increased risk of spontaneous abortion when comparing ETV with tenofovir disoproxil fumarate (TDF) and telbivudine (LdT), with RORs equal to 1.58 (95% CI, 1.09–2.30) and 2.13 (95% CI, 1.04–4.36), respectively. However, when the included reports were limited to indication containing HBV infection, no signals for increased AEDP were detected. Futhermore, a strong signal for increased risk of spontaneous abortion was identified in patients with HBV infection when comparing ETV or ADV with lamivudine (LAM), with RORs of 3.55 (95% CI, 1.54–8.18) and 2.85 (95% CI, 1.15–7.08), respectively.Conclusion: We found a strong signal for increased risk of spontaneous abortion in patients with HBV infection taking ETV or ADV, in comparison with those prescribed with LAM. Moreover, no obvious signal association of human teratogenicity with exposure to ETV or ADV was identified in fetuses during pregnancy. Nevertheless, owing to the limitations of a spontaneous reporting database, which inevitably contains potential biases, there is a pressing need for well-designed comparative safety studies to validate these results in clinical practice.

scholarly journals Safety of BRAF+MEK Inhibitor Combinations: Severe Adverse Event Evaluation

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1650
Author(s):  
Tomer Meirson ◽  
Nethanel Asher ◽  
David Bomze ◽  
Gal Markel
Keyword(s):  
Adverse Event ◽  
Adverse Event Reporting System ◽  
Mek Inhibitor ◽  
Adverse Event Reporting ◽  
Stevens Johnson Syndrome ◽  
Reporting Odds Ratio ◽  
Serious Adverse Events ◽  
Johnson Syndrome ◽  
Increased Risk ◽  
Melanoma Patients

Aim: The selective BRAF and MEK inhibitors (BRAFi+MEKi) have substantially improved the survival of melanoma patients with BRAF V600 mutations. However, BRAFi+MEKi can also cause severe or fatal outcomes. We aimed to identify and compare serious adverse events (sAEs) that are significantly associated with BRAFi+MEKi. Methods: In this pharmacovigilance study, we reviewed FDA Adverse Event Reporting System (FAERS) data in order to detect sAE reporting in patients treated with the combination therapies vemurafenib+cobimetinib (V+C), dabrafenib+trametinib (D+T) and encorafenib+binimetinib (E+B). We evaluated the disproportionate reporting of BRAFi+MEKi-associated sAEs. Significant associations were further analyzed to identify combination-specific safety signals among BRAFi+MEKi. Results: From January 2018 through June 2019, we identified 11,721 sAE reports in patients receiving BRAFi+MEKi. Comparison of BRAFi+MEKi combinations demonstrates that skin toxicities, including Stevens–Johnson syndrome, were disproportionally reported using V+C, with an age-adjusted reporting odds ratio (adj. ROR) of 3.4 (95%CI, 2.9–4.0), whereas fever was most significantly associated with D+T treatment with an adj. ROR of 1.9 (95%CI, 1.5–2.4). Significant associations using E+B treatment include peripheral neuropathies (adj. ROR 2.7; 95%CI, 1.2–6.1) and renal disorders (adj. ROR 4.1; 95%CI, 1.3–12.5). Notably, we found an increase in the proportion of Guillain–Barré syndrome reports (adj. ROR 8.5; 95%CI, 2.1–35.0) in patients administered E+B. Conclusion: BRAFi+MEKi combinations share a similar safety profile attributed to class effects, yet concomitantly, these combinations display distinctive effects that can dramatically impact patients’ health. Owing to the limitations of pharmacovigilance studies, some findings warrant further validation. However, the possibility of an increased risk for these events should be considered in patient care.

scholarly journals Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System

Vaccine ◽  
2014 ◽  
Vol 32 (37) ◽  
pp. 4758-4765 ◽  
Author(s):  
Michael M. McNeil ◽  
Maria Cano ◽  
Elaine R. Miller ◽  
Brett W. Petersen ◽  
Renata J.M. Engler ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Smallpox Vaccine ◽  
Cardiac Events ◽  
Event Reporting
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