Disproportionality analysis of reported drug adverse events to assess a potential safety signal for pentavalent vaccine in 2019 in El Salvador

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

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Safety of switching between rituximab biosimilars in onco-hematology

Scientific Reports ◽

10.1038/s41598-021-85563-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Silvana A. M. Urru ◽

Stefania Spila Alegiani ◽

Anna Guella ◽

Giuseppe Traversa ◽

Annalisa Campomori

Keyword(s):

Chronic Lymphocytic Leukemia ◽

Adverse Events ◽

Prospective Observational Study ◽

Randomized Trials ◽

Lymphocytic Leukemia ◽

Safety Signal ◽

Efficacy And Safety ◽

Clinical Safety ◽

Study Population ◽

Grade 3

AbstractComparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective observational study we aimed at evaluating the safety of switching between reference and biosimilar rituximab (TRUXIMA and RIXATHON) at Trento General Hospital (Italy). All patients (n = 83) with Non Hodgkin’s Lymphoma (NHL, n = 72) and Chronic Lymphocytic Leukemia (CLL, n = 11) who received rituximab between March 2018 and March 2019 were asked to take part in the study. In 2017 and 2018 two tenders were carried out and two different biosimilars became available in the hospital, these were used sequentially. Thus, patients with or without previous treatments with the originator rituximab either received a biosimilar or were switched between different biosimilars. The incidence of adverse events in these groups of patients is described. The study population received 465 rituximab infusions and all received biosimilars. Fifty patients (60%) experienced at least one switch between different biosimilars or between rituximab originator and biosimilar, whereas 33 (40%) received one of the two biosimilars and one patient received reference rituximab. Adverse events (n = 146) were reported in 71 patients (84.5%). Treatment-related grade 3–4 events were reported in 5 patients (5.9%), whereas grade 1 rituximab related infusion events were observed in 6 patients (7.1%). No safety signal emerged in association with the use of a specific biosimilar nor with the practice of switching. Adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of rituximab biosimilars.

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A characterization and disproportionality analysis of medication error related adverse events reported to the FAERS database

Expert Opinion on Drug Safety ◽

10.1080/14740338.2018.1550069 ◽

2018 ◽

Vol 17 (12) ◽

pp. 1161-1169 ◽

Cited By ~ 3

Author(s):

Carla Carnovale ◽

Faizan Mazhar ◽

Marco Pozzi ◽

Marta Gentili ◽

Emilio Clementi ◽

...

Keyword(s):

Adverse Events ◽

Medication Error ◽

Disproportionality Analysis

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Adverse events following immunization with pentavalent vaccine in a tertiary care hospital

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20175139 ◽

2017 ◽

Vol 5 (1) ◽

pp. 82

Author(s):

Sharad Bansal

Keyword(s):

Adverse Events ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Cost Effective ◽

Care Hospital ◽

Immunization Programs ◽

Global Alliance ◽

Immunization Program ◽

Pentavalent Vaccine ◽

Mild Fever

Background: Immunizations currently save 3 million lives per year throughout the world and is one of the most cost-effective health interventions. The Global Alliance for Vaccines and Immunizations (GAVI) and WHO recommended the use of pentavalent to replace the DPT vaccine in developing countries. Vaccines related most side effects are mild and non-serious. Surveillance of adverse events following immunization will enable us to monitor the safety of immunization programs and thereby contribute to validating the immunization program. The main aim of this study is to analyze all suspected adverse events in children reported for pentavalent vaccination.Methods:A prospective, observational epidemiological study was conducted in the department of Paediatrics OPD at tertiary care teaching institute during October 2016 to December 2016. The study was conducted amongst 190 children attending the department of Paediatrics OPD for the second or third dose of pentavalent vaccine.Results: The study shows the following adverse effects after pentavalent injection 127 (66.8%) children had pain at the site of injection, 103(54.2%) mild fever, Swelling at injection site 84(44.2%) and 55(28.9%) children held their leg back due to pain. In majority 85 (44.7%) of children antipyretic and in 65 (34.2%) children analgesic was given was given to relieve the symptoms. The parents were very positive for completing their children’s immunization schedule even though they have faced few symptoms.Conclusions:It can be concluded that all the adverse events reported were mild and could be managed easily without any complications.

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Neurologic Safety Monitoring of COVID-19 Vaccines: Lessons From the Past to Inform the Present

Neurology ◽

10.1212/wnl.0000000000012703 ◽

2021 ◽

pp. 10.1212/WNL.0000000000012703

Author(s):

Kiran Teresa Thakur ◽

Samantha Epstein ◽

Amanda Bilski ◽

Alanna Balbi ◽

Amelia K Boehme ◽

...

Keyword(s):

Adverse Events ◽

Adenovirus Vector ◽

Safety Monitoring ◽

Current Data ◽

Significant Morbidity ◽

Medical Interventions ◽

The Past ◽

Safety Risks ◽

Potential Safety ◽

Neurological Conditions

The spread of the SARS-CoV-2 virus has triggered a global effort to rapidly develop and deploy effective and safe COVID-19 vaccination(s). Vaccination has been one of the most effective medical interventions in human history, though potential safety risks of novel vaccines must be monitored, identified, and quantified. Adverse events must be carefully assessed to define whether they are causally associated with vaccination or coincidence. Neurological adverse events following immunizations are overall rare but with significant morbidity and mortality when they occur. Here, we review neurological conditions seen in the context of prior vaccinations and the current data to date on select COVID-19 vaccines including mRNA vaccine(s) and the adenovirus-vector COVID-19 vaccines, ChAdOx1 nCOV-19 (AstraZeneca) and Ad26.COV2.S Johnson and Johnson (Janssen/J&J).

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Detecting a potential safety signal of antidepressants and type 2 diabetes: a pharmacovigilance-pharmacodynamic study

British Journal of Clinical Pharmacology ◽

10.1111/bcp.13699 ◽

2018 ◽

Vol 84 (10) ◽

pp. 2405-2414 ◽

Cited By ~ 11

Author(s):

Spyridon Siafis ◽

Georgios Papazisis

Keyword(s):

Type 2 Diabetes ◽

Safety Signal ◽

Potential Safety ◽

Pharmacodynamic Study

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Two-stage Bayesian hierarchical modeling for blinded and unblinded safety monitoring in randomized clinical trials

BMC Medical Research Methodology ◽

10.1186/s12874-020-01097-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Junhao Liu ◽

Jo Wick ◽

Renee’ H. Martin ◽

Caitlyn Meinzer ◽

Dooti Roy ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Drug Safety ◽

Safety Data ◽

Safety Monitoring ◽

Safety Signal ◽

Two Stage ◽

Bayesian Hierarchical ◽

Potential Safety ◽

Stage 1

Abstract Background Monitoring and reporting of drug safety during a clinical trial is essential to its success. More recent attention to drug safety has encouraged statistical methods development for monitoring and detecting potential safety signals. This paper investigates the potential impact of the process of the blinded investigator identifying a potential safety signal, which should be further investigated by the Data and Safety Monitoring Board with an unblinded safety data analysis. Methods In this paper, two-stage Bayesian hierarchical models are proposed for safety signal detection following a pre-specified set of interim analyses that are applied to efficacy. At stage 1, a hierarchical blinded model uses blinded safety data to detect a potential safety signal and at stage 2, a hierarchical logistic model is applied to confirm the signal with unblinded safety data. Results Any interim safety monitoring analysis is usually scheduled via negotiation between the trial sponsor and the Data and Safety Monitoring Board. The proposed safety monitoring process starts once 53 subjects have been enrolled into an eight-arm phase II clinical trial for the first interim analysis. Operating characteristics describing the performance of this proposed workflow are investigated using simulations based on the different scenarios. Conclusions The two-stage Bayesian safety procedure in this paper provides a statistical view to monitor safety during the clinical trials. The proposed two-stage monitoring model has an excellent accuracy of detecting and flagging a potential safety signal at stage 1, and with the most important feature that further action at stage 2 could confirm the safety issue.

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