Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India

Kalaiselvan, Vivekanandan; Tripathi, Arunabh; Saurabh, Archana; Kumar, Ranvir; Kumar, Rajan; Thota, Prasad; Singh, Gyanendra

doi:10.1177/2168479015589822

Cited by 12 publications

(5 citation statements)

References 11 publications

(16 reference statements)

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“…Formulas to calculate PRR and ROR are shown in Fig. 2 and formulas for chi-square with Yates' correction and IC 025 have previously been described [8][9][10].…”

Section: Disproportionality Analysismentioning

confidence: 99%

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Aggarwal

Chow

2021

Anesth Pain Med

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Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. Conclusions: Further studies such as randomized controlled trials are needed to validate the findings.

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“…Formulas to calculate PRR and ROR are shown in Fig. 2 and formulas for chi-square with Yates' correction and IC 025 have previously been described [8][9][10].…”

Section: Disproportionality Analysismentioning

confidence: 99%

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Aggarwal

Chow

2021

Anesth Pain Med

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“…2. The Information Component (IC 025 ≥ 0): The IC is a Bayesian tool to estimate the degree of the quantitative correlation between a target drug and a target event 22 . A positive Information Component (IC) indicates a stronger than predicted relationship between the drug and ADR; IC values which are negative or near zero, indicate no relationship at all.…”

Section: Statistical Toolsmentioning

confidence: 99%

“…Basically, the Two by Two table, which is displayed below (table-2), is used to calculate PRR [20]. Which can be expressed as: The PRR is an easy-to-understand statistic that expresses every aspect of the increased risk of an ADR in the drug-exposed category over the drug-unexposed category [21,22].…”

Section: Statistical Toolsmentioning

confidence: 99%

Neuronal toxicity of Monoclonal antibodies (mAbs): An analysis of post marketing reports from FDA Adverse Event Reporting System (FAERS) safety database

Kumar,

Kalaiselvan,

Arora

2024

Preprint

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Background: Monoclonal antibodies (mAbs), are pivotal in treating various diseases including cancers and autoimmune disorders. Despite their therapeutic benefits, mAbs therapy has been associated with neurological toxicity. Objectives: This study aimed to assess the incidence of neuronal toxicity associated with mAbs, utilizing data from the FDA Adverse Event Reporting System (FAERS) safety database. The study also sought to delineate the medical characteristics of the reported cases. Methods: A comprehensive analysis of neurological adverse events reported in the FAERS database was conducted, employing computational methodologies such as proportional relative risk (PRR), information component (IC025), and Chi-Square (χ2). Individual case safety reports (ICSRs) pertaining to neurological disorders linked to mAbs from the date of first global marketing authorization until June 30, 2023, were meticulously examined. Results: The FAERS safety database contains 79,022 Individual Case Safety Reports (ICSRs) linking monoclonal antibodies (mAbs) to Nervous system disorders. Rituximab, Bevacizumab, Denosumab, Nivolumab, and Trastuzumab were frequently cited. Reported adverse events include headache, peripheral neuropathy, dizziness, and cerebrovascular accident. Most ICSRs (85.81%) were serious, mainly affecting females (57.04%) with a 14.09% fatality rate. Panitumumab, Atezolizumab, Bevacizumab, and Trastuzumab showed strong drug-event associations. Signal Disproportionate Reporting (SDR) analysis flagged myasthenia gravis, peripheral neuropathy, and neurotoxicity across multiple mAbs, suggesting potential signals. Conclusions: Interdisciplinary collaboration between oncologists and neurologists is crucial for safe mAb use. Our study enhances understanding of mAb neurological safety. Disproportionality signal analysis provides valuable evidence for risk mitigation.

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“…The main objective of the PvPI is to identify signals and to minimize the risk associated with the use of medications in the public of India. [1314] At present, 250 ADR monitoring centers (AMCs) are working under the umbrella of PvPI to monitor and report ADRs to NCC-PvPI. The program is steered from IPC, Ghaziabad.…”

Section: Role Of Pharmacovigilance Programme Of Indiamentioning

confidence: 99%

Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India

Agrawal¹,

Shrivastava

Adusumilli

et al. 2019

Perspect Clin Res

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Misuse of antimicrobials has become one of the grave concerns of public health. In last two decades, this has been largely contributing in the emergence of antimicrobial resistance (AMR) among all the pathogens. A 2013 report of Centres for Disease Control and Prevention, USA figured that at least 2 million people get an antibiotic-resistant infection every year and as many as 23,000 people lost their life. A multi-country survey in Southeast Asia region conducted by World Health Organization (WHO) in 2015, identified several gaps in knowledge and awareness about the optimal use of antimicrobials and AMR. Following this, the Ministry of Health and Family Welfare (MoHFW), Government of India, developed National Action Plan in the year 2017 to combat AMR. Pharmacovigilance Programme of India (PvPI) being a flagship programme of MoHFW holds the responsibility of ensuring safety of medicines used by India population and has recently identified AMR as one of the strategic priorities. This article intends to provide insights of the recent attempts and deliberate efforts made by PvPI in the containment of AMR in India and it also intends to sensitize healthcare fraternity on restricting AMR in public interest.

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Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India

Abstract: The proposed methods may help in the identification of new signals in Indian individual case safety reports.

Cited by 12 publications

References 11 publications

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Neuronal toxicity of Monoclonal antibodies (mAbs): An analysis of post marketing reports from FDA Adverse Event Reporting System (FAERS) safety database

Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India

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