Dipeptidyl peptidase-4 inhibitors and heart failure: Analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System

2016 ◽  
Vol 26 (5) ◽  
pp. 380-386 ◽  
Author(s):  
E. Raschi ◽  
E. Poluzzi ◽  
A. Koci ◽  
I.C. Antonazzo ◽  
G. Marchesini ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Event ◽  
Failure Analysis ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Dipeptidyl Peptidase 4 ◽  
Spontaneous Reports ◽  
Dipeptidyl Peptidase 4 Inhibitors

scholarly journals Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jing Huang ◽  
Yuntao Jia ◽  
Shusen Sun ◽  
Long Meng
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Dipeptidyl Peptidase ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Dipeptidyl Peptidase 4 ◽  
Dipeptidyl Peptidase 4 Inhibitors

Abstract Background To describe and analyze the patterns of adverse events associated with dipeptidyl peptidase-4 inhibitors (DPP-4is) (sitagliptin, saxagliptin, linagliptin, vildagliptin, and alogliptin) from the FDA Adverse Event Reporting System (FAERS) and to highlight areas of safety concerns. Methods Adverse events spontaneously submitted to the FAERS between 2004 Q1 to 2019 Q2 were included. The online tool OpenVigil 2.1 was used to query the database. The research relied on definitions of preferred terms (PTs) specified by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ). The reporting odds ratio (ROR), with 95% confidence intervals (CIs) was calculated for disproportionality analysis. Results Over 16 years, a total of 9706 adverse event reports were identified. Alogliptin was excluded from further analysis due to insufficient sample size. Compared with the non-insulin antidiabetic drugs, the four DPP-4is were all disproportionately associated with four SMQs: “gastrointestinal nonspecific inflammation and dysfunctional conditions,” “hypersensitivity,” “severe cutaneous adverse reactions,” and “noninfectious diarrhoea”. As for PT level analyses, DPP-4is are associated with higher reporting of the gastrointestinal tract, pancreas, malignancies, infection, musculoskeletal disorders, general disorders, hypersensitivity, and skin AEs. Conclusions Data mining of the FAERS is useful for examining DPP-4 inhibitors-associated adverse events. The findings of the present study are compatible with clinical experience, and it provides valuable information to decision-makers and healthcare providers in clinical practice.

scholarly journals Descriptive Analysis of Reported Adverse Events Associated with Antiobesity Medications Using FDA Adverse Event Reporting System (FAERS) Databases 2013-2020

2021 ◽  
Author(s):  
Abdulrahman Alsuhibani ◽  
Marwan Alrasheed ◽  
Musaab Gari ◽  
Ana Hincapie ◽  
Jianfei Guo
Keyword(s):  
Adverse Event ◽  
Cardiovascular Diseases ◽  
Adverse Events ◽  
Reporting System ◽  
Descriptive Analysis ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Spontaneous Reports ◽  
Life Threatening

Abstract Background Obesity is a globally growing health problem, and its treatment has been challenging. The usage of antiobesity medications (AOMs) has been associated with severe adverse events (AEs). Spontaneous reports of AOMs can present detailed information about AEs occurring after the time of marketing. Several AOMs have been withdrawn from the market owing to documented AEs. Objective To estimate and characterize the frequency of AEs attributable to the use of the AOMs between January 2013 and June 2020. Setting: US FDA Adverse Event Reporting System (FAERS) between January 01, 2013, and June 31, 2020, Methods A retrospective, descriptive analysis was conducted to analyze all major reported AEs including death, life-threatening, hospitalization, disability, and required intervention or congenital anomaly related to AOMs. The total numbers of AEs reports, cases, adverse reactions and outcomes were calculated for each medication, and patients' mean age and gender were reported. Results We found a total of 18,675 unique AEs reports associated with AOMs used for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most patients were female adults (73.4 %). The main AEs of the safety reports were nausea, headache, cardiovascular diseases, dizziness, drug ineffectiveness, acute kidney failure/ kidney injury, and dry mouth. The FAERS database had 21,229 unique outcomes involving AOMs use, including 1,039 deaths (fatality ratio of 4.9% of all analyzed reports), 1,613 (7.6%) life-threatening events, 7,426 (35%) hospitalizations, and 1,249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. The cardiovascular AEs were 542 reports (31%) for phentermine, 402 reports (23%) for liraglutide, 381 reports (22%) for phentermine/topiramate. Conclusion Although several AOMs have been withdrawn from the market and replaced with new ones, the utilization of the AOMs is widespread; the FAERS database's analysis revealed many serious AEs in the type of cardiovascular diseases and kidney complications attributable to the use of the AOMs. Therefore, it is necessary to continue and systematically monitor AOMs' safety to help optimize their use.

scholarly journals Development of a Network-Based Signal Detection Tool: The COVID-19 Adversome in the FDA Adverse Event Reporting System

2021 ◽  
Vol 12 ◽  
Author(s):  
Michele Fusaroli ◽  
Emanuel Raschi ◽  
Milo Gatti ◽  
Fabrizio De Ponti ◽  
Elisabetta Poluzzi
Keyword(s):  
Adverse Event ◽  
Signal Detection ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Event Reporting ◽  
Vein Thrombosis ◽  
Spontaneous Reports ◽  
Effective Signal

Introduction: The analysis of pharmacovigilance databases is crucial for the safety profiling of new and repurposed drugs, especially in the COVID-19 era. Traditional pharmacovigilance analyses–based on disproportionality approaches–cannot usually account for the complexity of spontaneous reports often with multiple concomitant drugs and events. We propose a network-based approach on co-reported events to help assessing disproportionalities and to effectively and timely identify disease-, comorbidity- and drug-related syndromes, especially in a rapidly changing low-resources environment such as that of COVID-19.Materials and Methods: Reports on medications administered for COVID-19 were extracted from the FDA Adverse Event Reporting System quarterly data (January–September 2020) and queried for disproportionalities (Reporting Odds Ratio corrected for multiple comparisons). A network (the Adversome) was estimated considering events as nodes and conditional co-reporting as links. Communities of significantly co-reported events were identified. All data and scripts employed are available in a public repository.Results: Among the 7,082 COVID-19 reports extracted, the seven most frequently suspected drugs (remdesivir, hydroxychloroquine, azithromycin, tocilizumab, lopinavir/ritonavir, sarilumab, and ethanol) have shown disproportionalities with 54 events. Of interest, myasthenia gravis with hydroxychloroquine, and cerebrovascular vein thrombosis with azithromycin. Automatic clustering identified 13 communities, including a methanol-related neurotoxicity associated with alcohol-based hand-sanitizers and a long QT/hepatotoxicity cluster associated with azithromycin, hydroxychloroquine and lopinavir-ritonavir interactions.Conclusion: Findings from the Adversome detect plausible new signals and iatrogenic syndromes. Our network approach complements traditional pharmacovigilance analyses, and may represent a more effective signal detection technique to guide clinical recommendations by regulators and specific follow-up confirmatory studies.

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

2020 ◽  
Vol 90 (1) ◽  
pp. 41-48
Author(s):  
Chiara Gastaldon ◽  
Emanuel Raschi ◽  
John M. Kane ◽  
Corrado Barbui ◽  
Georgios Schoretsanitis
Keyword(s):  
Adverse Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Mood Stabilizers ◽  
Reporting Odds Ratio ◽  
Event Reporting ◽  
Completed Suicide ◽  
Spontaneous Reports ◽  
Post Marketing

<b><i>Introduction:</i></b> Esketamine nasal spray received approval for treatment-resistant depression in March 2019. <b><i>Objective:</i></b> Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. <b><i>Methods:</i></b> We used the consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. <b><i>Results:</i></b> The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (χ<sup>2</sup> = 125.29, <i>p</i> &#x3c; 0.001, χ<sup>2</sup> = 9.08, <i>p</i> = 0.003, χ<sup>2</sup> = 8.14, <i>p</i> = 0.004, χ<sup>2</sup> = 19.48, <i>p</i> &#x3c; 0.001, χ<sup>2</sup> = 25.62, <i>p</i> &#x3c; 0.001, and χ<sup>2</sup> = 16.79, <i>p</i> &#x3c; 0.001, respectively). <b><i>Conclusions:</i></b> Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.

Sign in / Sign up

Export Citation Format

Share Document