scholarly journals FDA Individual Case Safety Report Terminology

2020 ◽  
Author(s):  
Keyword(s):  
Individual Case ◽  
Individual Case Safety Report ◽  
Safety Report

scholarly journals Training Augmented Intelligent Capabilities for Pharmacovigilance: Applying Deep-learning Approaches to Individual Case Safety Report Processing

2018 ◽  
Vol 32 (6) ◽  
pp. 391-401 ◽  
Author(s):  
Danielle Abatemarco ◽  
Sujan Perera ◽  
Sheng Hua Bao ◽  
Sameen Desai ◽  
Bruno Assuncao ◽  
...  
Keyword(s):  
Deep Learning ◽  
Individual Case ◽  
Learning Approaches ◽  
Individual Case Safety Report ◽  
Safety Report

scholarly journals Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

2020 ◽  
Vol 29 (2) ◽  
pp. 17-26
Author(s):  
Ahmed M. Hameed ◽  
Dheyaa J. Kadhim ◽  
Manal M. Younus
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Subcutaneous Tissue ◽  
Individual Case ◽  
Gastrointestinal Disorders ◽  
Drug Reactions ◽  
Individual Case Safety Report ◽  
Safety Report ◽  
Pharmacovigilance Center

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database

2020 ◽  
Author(s):  
Joachim Alexandre ◽  
Joe-Elie Salem ◽  
Javid Moslehi ◽  
Marion Sassier ◽  
Camille Ropert ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticancer Drugs ◽  
Kinase Inhibitors ◽  
Descriptive Analysis ◽  
Individual Case ◽  
World Health ◽  
European Medicines Agency ◽  
Individual Case Safety Report ◽  
Pharmacovigilance Database ◽  
Haematologic Malignancies

Abstract Aims The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF. Methods and results A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody. Conclusion Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.

scholarly journals Cardiac Inflammation after COVID-19 mRNA Vaccines: A Global Pharmacovigilance Analysis

2021 ◽  
Author(s):  
Laurent Chouchana ◽  
Alice Blet ◽  
Mohammad Al-Khalaf ◽  
Tahir S Kafil ◽  
Girish Nair ◽  
...  
Keyword(s):  
Adverse Event Reporting System ◽  
Individual Case ◽  
Global Scale ◽  
Adverse Event Reporting ◽  
World Health ◽  
Medical Attention ◽  
Safety Signal ◽  
Individual Case Safety Report ◽  
Disproportionate Reporting ◽  
The U.S

Background To counter the COVID-19 pandemic, mRNA vaccines, namely tozinameran and elasomeran, have been authorized in several countries. These next generation vaccines have shown high efficacy against COVID-19 and demonstrated a favorable safety profile. As widespread vaccinations efforts are taking place, incidents of myocarditis and pericarditis cases following vaccination have been reported. This safety signal has been recently confirmed by the European Medicine Agency and the U.S. Food and Drug Administration. This study aimed to investigate and analyze this safety signal using a dual pharmacovigilance database analysis. Methods This is as an observational study of reports of inflammatory heart reactions associated with mRNA COVID-19 vaccines reported in the World Health Organization's global individual case safety report database (up to June 30th 2021), and in the U.S. Vaccine Adverse Event Reporting System (VAERS, up to May 21st 2021). Cases were described, and disproportionality analyses using reporting odds-ratios (ROR) and their 95% confidence interval (95%CI) were performed to assess relative risk of reporting according to patient sex and age. Results At a global scale, the inflammatory heart reactions most frequently reported were myocarditis (1241, 55%) and pericarditis (851, 37%), the majority requiring hospitalization (n=796 (64%)). Overall, patients were young (median age 33 [21-54] years). The main age group was 18-29 years old (704, 31%), and mostly males (1555, 68%). Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3-21] vs. 3 [2-6] days, respectively (p=0.001). Regarding myocarditis, an important disproportionate reporting in males (ROR, 9.4 [8.3-10.6]) as well as in adolescents (ROR, 22.3 [19.2-25.9]) and 18-29 years old (ROR, 6.6 [5.9-7.5]) compared to older patients were observed. Conclusions The inflammatory heart reactions, namely myocarditis and pericarditis, have been reported world-wide shortly following COVID-19 mRNA vaccination. An important disproportionate reporting among adolescents and young adults, particularly in males, was observed especially for myocarditis. Guidelines must take this specific risk into account and to optimize vaccination protocols according to sex and age. While the substantial benefits of COVID-19 vaccination still prevail over risks, clinicians and the public should be aware of these reactions and seek appropriate medical attention.

β-adrenoceptor antagonists and nightmares: A pharmacoepidemiological–pharmacodynamic study

2021 ◽  
pp. 026988112110348
Author(s):  
Philippe Garcia ◽  
Jean-Louis Montastruc ◽  
Vanessa Rousseau ◽  
Jacques Hamard ◽  
Agnès Sommet ◽  
...  
Keyword(s):  
Individual Case ◽  
World Health ◽  
Lipid Solubility ◽  
Multivariate Logistic Regression ◽  
Individual Case Safety Report ◽  
High Lipid ◽  
Increased Risk ◽  
Pharmacodynamic Analysis ◽  
Health Organization ◽  
High Lipid Solubility

Aim: To compare different β-adrenoceptor antagonists for the risk of reporting nightmare. Methods: The study involved two approaches: first, we investigated in VigiBase®, the World Health Organization Individual Case Safety Report (ICSR) database, the disproportionality between exposure to each β-adrenoceptor antagonists and reports of nightmares between 1967 and 2019. Second, in a pharmacoepidemiological–pharmacodynamic analysis, we assessed whether use of β-adrenoceptor antagonists with moderate and high lipid solubility or strong 5-HT1A affinity were associated with an increased risk of reporting nightmares. We conducted multivariate logistic regression to estimate reporting odds ratios (RORs) of nightmares compared to all other adverse drug reactions. Results: Of the 126,964 reports recorded with β-adrenoceptor antagonists, 1138 (0.9%) were nightmares. The highest risk of reporting a nightmare was found with exposure of pindolol (adjusted ROR 2.82, 95%CI, 2.19–3.61), metoprolol (1.89, 1.66–2.16), and alprenolol (1.77, 1.06–2.97). Compared to use of low lipid solubility β-adrenoceptor antagonists, use of moderate or high lipid solubility β-adrenoceptor antagonists were significantly more associated with nightmare reports (aROR moderate vs. low 1.72, 95%CI 1.47–2.00 and aROR high vs. low 1.84, 95%CI 1.53–2.22). Use of moderate or high 5-HT1A affinity of β-adrenoceptor antagonists was associated with an increased ROR of nightmares compared with low 5-HT1A affinity of β-adrenoceptor antagonists (aROR moderate vs. low 1.22, 95%CI 1.04–1.43 and aROR high vs. low 2.46, 95%CI 1.93–3.13). Conclusion: In our large pharmacovigilance study, nightmares are more frequently reported for pindolol and metoprolol, and among β-adrenoceptor antagonists with high lipid solubility and high 5-HT1A receptor affinity.

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