How covid-19 vaccines exposed India’s adverse events reporting system

Critically ill patients admitted to critical-care units (CCUs) might have life-threatening or potentially life-threatening problems. Adverse events (AEs) occur frequently in CCUs, resulting in compromised quality of patient care. This study explores the experiences of critical-care nurses (CCNs) in relation to how the reported AEs were analysed and handled in CCUs. The study was conducted in the CCUs of five purposively selected hospitals in KwaZulu-Natal, South Africa. A descriptive qualitative design was used to obtain data through in-depth interviews from a purposive sample of five unit managers working in the CCUs to provide a deeper meaning of their experiences. This study was a part of a bigger study using a mixed-methods approach. The recorded qualitative data were analysed using Tesch’s content analysis. The main categories of information that emerged during the data analysis were (i) the existence of an AE reporting system, (ii) the occurrence of AEs, (iii) the promotion of and barriers to AE reporting, and (iv) the handling of AEs. The findings demonstrated that there were major gaps that affected the maximum utilisation of the reporting system. In addition, even though the system existed in other institutions, it was not utilised at all, hence affecting quality patient care. The following are recommended: (1) a non-punitive and non-confrontational system should be promoted, and (2) an organisational culture should be encouraged where support structures are formed within institutions, which consist of a legal framework, patient and family involvement, effective AE feedback, and education and training of staff.

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Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Current Drug Safety ◽

10.2174/1574886313666181026100000 ◽

2019 ◽

Vol 14 (1) ◽

pp. 21-26 ◽

Cited By ~ 2

Author(s):

Viswam Subeesh ◽

Eswaran Maheswari ◽

Hemendra Singh ◽

Thomas Elsa Beulah ◽

Ann Mary Swaroop

Keyword(s):

Data Mining ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Disproportionality Analysis ◽

Positive Signal ◽

Data Mining Algorithms ◽

Mining Algorithms

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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The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽

10.3390/cancers13010024 ◽

2020 ◽

Vol 13 (1) ◽

pp. 24

Author(s):

Gerald McGwin

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Large Body ◽

Science Research ◽

Gastrointestinal System ◽

Gastrointestinal Cancers ◽

H2 Antagonists ◽

Study Results ◽

Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

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Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽

10.1016/j.vaccine.2019.08.087 ◽

2019 ◽

Vol 37 (44) ◽

pp. 6760-6767 ◽

Cited By ~ 2

Author(s):

Michael M. McNeil ◽

Iwona Paradowska-Stankiewicz ◽

Elaine R. Miller ◽

Paige L. Marquez ◽

Srihari Seshadri ◽

...

Keyword(s):

United States ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adenovirus Type ◽

Adverse Event Reporting ◽

Event Reporting

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Descriptive epidemiology of adverse events after immunization: Reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994

The Journal of Pediatrics ◽

10.1016/s0022-3476(97)70056-8 ◽

1997 ◽

Vol 131 (4) ◽

pp. 529-535 ◽

Cited By ~ 32

Author(s):

M.Miles Braun ◽

Susan S. Ellenberg

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Descriptive Epidemiology ◽

Event Reporting

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Intraocular devices associated adverse events reporting system in India

Indian Journal of Ophthalmology ◽

10.4103/ijo.ijo_298_20 ◽

2020 ◽

Vol 68 (11) ◽

pp. 2343

Author(s):

Vivekanandan Kalaiselvan ◽

Rohit Saxena

Keyword(s):

Adverse Events ◽

Reporting System

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Preliminary Analysis of Association Between COVID-19 Vaccination and Sudden Hearing Loss Using US Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System Data

JAMA Otolaryngology–Head & Neck Surgery ◽

10.1001/jamaoto.2021.0869 ◽

2021 ◽

Author(s):

Eric J. Formeister ◽

Wade Chien ◽

Yuri Agrawal ◽

John P. Carey ◽

C. Matthew Stewart ◽

...

Keyword(s):

Hearing Loss ◽

Adverse Events ◽

Disease Control ◽

Preliminary Analysis ◽

Reporting System ◽

Sudden Hearing Loss ◽

Control And Prevention ◽

System Data ◽

Centers For Disease Control

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Antidepressants-related cardiovascular adverse events using the adverse event reporting system

Psychiatry Research ◽

10.1016/j.psychres.2018.07.044 ◽

2018 ◽

Vol 268 ◽

pp. 441-446 ◽

Cited By ~ 2

Author(s):

Yoon Kyong Lee ◽

Jung Su Shin ◽

Youngwon Kim ◽

Jae Hyun Kim ◽

Yun-Kyoung Song ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting

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Health benefits of an adverse events reporting system for chronic pain patients using long-term opioids

Acta Anaesthesiologica Scandinavica ◽

10.1111/aas.13243 ◽

2018 ◽

Vol 63 (2) ◽

pp. 248-258 ◽

Cited By ~ 2

Author(s):

Beatriz Planelles ◽

César Margarit ◽

Raquel Ajo ◽

Yolanda Sastre ◽

Javier Muriel ◽

...

Keyword(s):

Chronic Pain ◽

Adverse Events ◽

Reporting System ◽

Health Benefits ◽

Chronic Pain Patients ◽

Pain Patients

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Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18790 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18790-e18790

Author(s):

Anahat Kaur ◽

Shuai Wang ◽

Arlene Yu ◽

Tarek N. Elrafei ◽

Lewis Steinberg ◽

...

Keyword(s):

Adverse Events ◽

Reporting System ◽

Case Reports ◽

Descriptive Analysis ◽

Package Insert ◽

Case Series ◽

The United States ◽

Chemotherapeutic Agents ◽

United States Food ◽

Pharmacovigilance Database

e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]

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