Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

Park, Susan; Choi, So-Hyun; Song, Yun‐Kyung; Kwon, Jin-Won

doi:10.2196/33311

Cited by 4 publications

(3 citation statements)

References 40 publications

(40 reference statements)

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“…Adverse events are categorized using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in the FAERS data. The GI hemorrhage adverse events were identified using Standardized MedDRA Queries (SMQ) in the adverse event field 14 . Specifically, the search strategy for identification of GI hemorrhage was querying the adverse event field with SMQ narrow term “gastrointestinal haemorrhage (SMQ).” As there were no IC hemorrhage‐specific SMQ, we followed an approach described by Shimada et al 15 .…”

Section: Methodsmentioning

confidence: 99%

“…The GI hemorrhage adverse events were identified using Standardized MedDRA Queries (SMQ) in the adverse event field. 14 Specifically, the search strategy for identification of GI hemorrhage was querying the adverse event field with SMQ narrow term "gastrointestinal haemorrhage (SMQ)." As there were no IC hemorrhage-specific SMQ, we followed an approach described by Shimada et al 15 First, we extracted all Preferred Terms (PTs) which are under both MedDRA System Organ Class (SOC) "Nervous System Disorders" and SMQ "Haemorrhage terms (excluding laboratory terms)" (SMQ code: 20000039).…”

Section: Me Thodsmentioning

confidence: 99%

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Antiviral influenza treatments and hemorrhage‐related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database

Sarker,

Carkovic,

Ptaszek

et al. 2024

Pharmacotherapy

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Study ObjectiveTo determine whether there is a signal for gastrointestinal (GI) or intracranial (IC) hemorrhage associated with the use of antiviral medications for influenza in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.DesignDisproportionality analysis.Data SourceThe FAERS database was searched using OpenVigil 2.1 to identify GI and IC hemorrhage events reported between 2004 and 2022.MeasurementsAntiviral medications for influenza included the following: oseltamivir, zanamivir, peramivir, and baloxavir marboxil. Hemorrhage events were identified using Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries for GI and IC hemorrhages. Reporting odds ratios (RORs) were calculated to compare the occurrence of GI and IC hemorrhage events between antiviral drugs for influenza and (i) all other medications and (ii) antibiotics. RORs were also calculated for each of the individual antiviral medications.Main ResultsA total of 245 cases of GI hemorrhage and 23 cases of IC hemorrhage were identified in association with four antivirals. In comparison with all other drugs, the RORs of GI hemorrhage for oseltamivir, zanamivir, peramivir, baloxavir, and all antivirals combined were 1.17, 0.62, 4.44, 2.53, and 1.22, respectively, indicating potential variations in GI hemorrhage risk among the antivirals. In contrast, in comparison with all other drugs, the RORs of IC hemorrhage for oseltamivir (0.44), zanamivir (0.16), baloxavir (0.44), and all antivirals combined (0.41) were less than 1.0 which is consistent with no elevated risk of IC hemorrhage.ConclusionIn this study, some signals for GI hemorrhage were observed, particularly for peramivir and baloxavir marboxil. Further investigation is warranted to better understand and evaluate the potential risks of GI hemorrhage associated with antiviral treatments for influenza.

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Section: Methodsmentioning

confidence: 99%

Section: Me Thodsmentioning

confidence: 99%

Antiviral influenza treatments and hemorrhage‐related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database

Sarker,

Carkovic,

Ptaszek

et al. 2024

Pharmacotherapy

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“…So far, most guidelines developed for selecting symptom measures were designed for clinical trials, and there is a lack of guidance for practitioners and for performing surveillance in the real-world clinical setting [ 10 ]. In fact, when the adverse events (AEs) were collected from the real world, new side effects related to the medication use not listed on the drug label have been reported [ 11 ]. Although a subset for practice was recently suggested based on a Delphi study with stakeholder panels [ 12 , 13 ], they only covered common cancers in Western countries, such as breast, lung, and colorectal cancers; further, the guidelines are limited to uncommon cancers, such as lymphoma, stomach, or liver cancers.…”

Section: Introductionmentioning

confidence: 99%

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

Kang¹,

Kim²,

Kim³

et al. 2023

JMIR Public Health Surveill

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Background Over 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients’ health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. Objective This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. Methods We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. Results The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient –8.15; 95% CI –9.32 to –6.97), difficulty in achieving and maintaining erection (coefficient –8.07; 95% CI –14.52 to –1.61), poor concentration (coefficient –7.54; 95% CI –9.06 to –6.01), and dizziness (coefficient –7.24; 95% CI –8.92 to –5.55). Conclusions The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements.

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The value of social media analysis for adverse events detection and pharmacovigilance: a Scoping Review (Preprint)

Golder,

O'Connor,

Wang

et al. 2024

JMIR Public Health and Surveillance

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Background: Adverse drug events pose a significant public health burden leading to hospitalisation, disability, and death. Even those adverse events categorised as non-serious can severely impact on patient quality of life, adherence, and persistence. Monitoring medication safety is challenging. Online patient reports on social media may be a useful supplementary source of realworld data. Despite the growth of sophisticated techniques for identifying adverse events using social media data, a consensus has not been reached as to the value of social media in relation to more traditional data sources.Objective: To evaluate and characterise the utility of social media analysis in adverse drug event detection and pharmacovigilance as compared to other data sources (such as spontaneous reporting systems and the clinical literature). Methods:In this scoping review, we searched 11 bibliographical databases and Google Scholar, followed by handsearching and forward and backward citation searching. Each records was screened by two independent reviewers at both title/abstract stage and the full-text screening stage. Studies were included if they 1) used any type of social media (such as Twitter or patient forums) to detect any adverse event associated with any drug medication and 2) compared the results ascertained from social media to any other data source. Study information was collated using a piloted data extraction sheet . Data were extracted on 1) the adverse events and drugs searched for and included, 2) the methods used (such as machine learning), 3) social media data source, 4) volume of data analysed, 5) limitations of the methodology, 6) availability of data and code, 7) comparison data source and comparison methods, 8) results, including the volume of adverse events, and how adverse events found compared to other data sources in their seriousness, frequencies, and expectedness/novelty (new vs. known knowledge) and 9) conclusions.Results: Of the 6538 unique records screened, 73 publications representing 60 studies and a wide variety of methods met our inclusion criteria. The most common social media platforms used were Twitter and online health forums. The most common comparator data source was spontaneous reporting systems, although other comparisons were made such as with scientific literature and product labels. Although similar patterns of adverse event reporting tended to be identified, the frequencies were lower in social media. Social media data were found useful in identifying new or unexpected adverse events and adverse events in a more timely manner.Conclusions: There is a large body of research comparing adverse events from social media to other sources. Most studies advocated the use of social media as an adjunct to traditional data sources. Some indicated the value of social media in understanding patient perspectives such as the impact of adverse events, which could be better explored.

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Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

Cited by 4 publications

References 40 publications

Antiviral influenza treatments and hemorrhage‐related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database

Antiviral influenza treatments and hemorrhage‐related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

The value of social media analysis for adverse events detection and pharmacovigilance: a Scoping Review (Preprint)

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