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Dentistry Journal Jul 2023Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have...
Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have risen in popularity among the general public and sparked debate among dental professionals. Dental professionals argue that using these aligners without an in-person diagnosis and treatment planning protocol set by a licensed dentist or orthodontist may lead to adverse effects on teeth and surrounding structures. The objective of this study is to describe adverse clinical events associated with the use of DTC sequential aligners as reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database. Methods-We searched the MAUDE database from 1 January 2010 to 31 December 2020 for the product code of 'NXC' (sequential aligners). The year, type of adverse event, reporter occupation, and event description were noted. Results-651 reports associated with sequential aligners were found, of which 104 were related to DTC sequential aligners. Fifty-four adverse events were reported in 2019. From the event description, 41.3% comprised bite problems, 29.8% comprised orofacial pain, and 26.6% of patients had some form of periodontal sequelae. Furthermore, 69.2% of the patients followed up after an adverse event with a dentist not associated with DTC aligners. Conclusions-The use of DTC sequential aligners without dental supervision has led to oral health problems, as documented in the MAUDE database. Commonly reported adverse events include bite problems, pain, sensitivity, and periodontal disease, and some adverse events are irreversible.
PubMed: 37504239
DOI: 10.3390/dj11070174 -
The Journal of Dermatological Treatment Dec 2023Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure.
Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest.
BACKGROUND
Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure.
OBJECTIVES
To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse event of special interest (AESI) to occur.
METHODS
Pooled analysis from two randomized controlled trials in patients with moderate-to-severe plaque psoriasis ( = 1800). PSOLAR registry was used as safety reference data for NNH estimation.
RESULTS
Rates of AESI with tildrakizumab were comparable with rates reported in PSOLAR. The NNH for one-year severe infection occurrence was 412 with tildrakizumab 200 mg, and negative for tildrakizumab 100 mg due to lower rates in reSURFACE trials; the NNH for malignancy was 990 for one year with tildrakizumab 100 mg (negative for tildrakizumab 200 mg); and the NNH for major adverse cardiovascular events was 355 for one year with tildrakizumab 200 mg (negative for tildrakizumab 100 mg).
CONCLUSION
Tildrakizumab demonstrated a favorable safety profile over 5 years with low rates of AESI, comparable to those of the PSOLAR. Consequently, the NNH for AESI with tildrakizumab were very high or negative due to lower event rates for tildrakizumab.
Topics: Humans; Antibodies, Monoclonal, Humanized; Patients; Psoriasis; Registries
PubMed: 37341303
DOI: 10.1080/09546634.2023.2220447 -
Dermatological Aspects of Nursing Oncology: Meaningful Observations Ensuring Better Quality of Life.Indian Journal of Palliative Care 2022Modern cancer management has changed over the period of time and now shifted to multidisciplinary care approach to ensure a better quality of life (QOL) of the surfing... (Review)
Review
Modern cancer management has changed over the period of time and now shifted to multidisciplinary care approach to ensure a better quality of life (QOL) of the surfing patients. Every form of cancer treatment has side effects and affects the QOL. Many of the side effects have been discussed in detail because of the need for timely interventions to prevent the consequences of the side effects. Dermatological adverse events due to cancer treatment are important but most commonly ignored in our clinical practice. Nursing staffs have a critical role in the early identification of such events and by briefing and training of the nursing staff in the identification of adverse events which can aid in the prevention of complications. As dermatologists may not be available round the clock, nursing staff are looking after the patients round the clock can prove very vital in screening cutaneous AE and adequately setting up referrals to aid early recognition and treatment of not only mild but also potentially life-threatening complications. The nursing staff, which is a cadre of health caregivers that are intimately involved in cancer care, can be trained to identify timely, skin-related adverse events. A literature search of scientific publications was done using the electronic databases PubMed, Science Direct, Cochrane Library, and Google Scholar. The search included terms 'Adverse events (AEs) post-chemotherapy,' 'AE post-radiotherapy,' 'AE post-immunotherapy,' 'AE post-hormonal therapy for cancer' and 'AE post-cancer surgery.' Data obtained from these studies and case reports were compiled and interpreted to prepare this review. This review focuses on various ways in which skin can be involved adversely as a part of cancer management and their classic and tell-tale signs to help the nurses in their better and quicker identification so that dermatologists are timely intimated and the treatment can be instituted to improve the patient's QOL.
PubMed: 35673687
DOI: 10.25259/IJPC_147_2021 -
Drugs - Real World Outcomes Sep 2016Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of...
BACKGROUND
Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frames, seasonality of ADEs may have implications for signal detection.
OBJECTIVE
The aim of this study was to investigate whether a set of illnesses that might be expected to display seasonality in general, did so when spontaneously reported as ADEs.
METHODS
We performed our analysis with the publically available US FDA Adverse Event Reporting System (FAERS) data. We selected a convenience sample of events possibly triggered by seasonal factors (hypothermia, Raynaud's phenomenon, photosensitivity reaction, heat exhaustion, heat stroke, and sunburn) and events for which previous literature experience suggests seasonality (anencephaly and interstitial lung disease). Our statistical procedures can be explained in terms of a simple physicogeometric setting: the unit circle divided into 6 (semiannual sinusoidal) or 12 (annual sinusoidal) arcs. When reporting frequencies (weights) are more or less evenly distributed across months, the center of mass of the circle would not be significantly displaced from the origin (0, 0). Distinct seasonal patterns will significantly displace the center of mass of the circle.
RESULTS
Various patterns of seasonality were identified for some, but not all, events and region-event pairs. USA displayed the most instances of seasonality. Scandinavia did not display seasonality for any events. Seasonality was usually annual sinusoidal. Possible explanations for failure to observe seasonality are briefly considered.
CONCLUSIONS
Understanding seasonality of spontaneous ADE reporting may have public health policy and research implications and may mitigate false-positive and missed true-positive pharmacovigilance signals. More systematic study of seasonality of spontaneous ADE reporting, including additional events with more or less biological rationale for seasonality, is a logical extension of this analysis.
PubMed: 27747826
DOI: 10.1007/s40801-016-0081-6 -
BMJ Quality & Safety Jul 2021To quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National...
OBJECTIVES
To quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.
DESIGN AND METHODS
A retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.
RESULTS
The percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).
CONCLUSION
Adverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.
Topics: Delivery of Health Care; Hospitalization; Hospitals; Humans; Incidence; Retrospective Studies
PubMed: 33436402
DOI: 10.1136/bmjqs-2020-011122 -
Indian Journal of Community Medicine :... 2022Minor adverse event following immunizations (AEFIs) are often underreported and self-treated. This study aimed to collect information regarding any and every probable...
BACKGROUND
Minor adverse event following immunizations (AEFIs) are often underreported and self-treated. This study aimed to collect information regarding any and every probable adverse event experienced by the recipient of Covishield vaccine up to 10 days following the first and second dose of vaccine. To find the incidence of minor adverse events following Covishield vaccination; draw an association between adverse events and individuals' demographic factors and comorbidities; and report new adverse events, if any.
MATERIALS AND METHODS
A descriptive observational study was conducted among 409 participants randomly sampled from the Vaccination Centre at a Tertiary Care Hospital, Mumbai. Participants were followed up post their first and second doses to enquire about adverse events.
RESULTS
Most commonly reported adverse events included injection site pain, tenderness, chills, fatigue, fever, and myalgia. Females reported more adverse events compared to men ( < 0.05). Younger individuals (18-24) experienced adverse events more as compared to individuals above 40 years of age ( < 0.005). Reported adverse events were lesser after the second dose in comparison with the first dose. Few participants reported dysgeusia.
CONCLUSIONS
Covishield vaccination has a mild AEFI profile, most commonly: injection site pain, tenderness, chills, and fatigue. It is hoped that the findings of this study will dispel anxiety around the adverse events of vaccination and reduce any persisting vaccine hesitancy. Effective communication with the population on vaccination will enable individuals to make educated and informed decisions.
PubMed: 36742958
DOI: 10.4103/ijcm.ijcm_93_22 -
Yakugaku Zasshi : Journal of the... 2020The Organisation for Economic Co-operation and Development (OECD) has initiated the adverse outcome pathway (AOP) Development Program in which the concept of AOP is... (Review)
Review
The Organisation for Economic Co-operation and Development (OECD) has initiated the adverse outcome pathway (AOP) Development Program in which the concept of AOP is applied to evaluate the safety of molecules such as chemicals. This program aims to assist regulatory needs and construct a knowledge base by accumulating AOP case studies. AOP consists of a molecular initiating event (MIE) as the initiating event of the pathway; key events (KEs) as the events themselves, such as cellular-molecular interactions; and adverse outcome (AO), such as signaling transduction-induced toxicity, as adverse events. KEs are extracted as important events at various levels, such as the molecular, cellular, tissue, organ, individual, and species levels; measurement of KEs and key event relationships (KERs), including mechanisms, plausibility, species differences, and empirical support information, are gathered. The development status of the AOP relating to histone deacetylase inhibition-induced testicular toxicity, currently being reviewed by the OECD, has been introduced. The AOP describing malignancies by Wnt ligand stimulation and Wnt signaling activation using gene expression network analysis-based mechanisms in molecular pathway elucidation has been suggested.
Topics: Adverse Outcome Pathways; Animals; Chemical Safety; Drug-Related Side Effects and Adverse Reactions; Gene Regulatory Networks; Humans
PubMed: 32238629
DOI: 10.1248/yakushi.19-00190-2 -
BMC Palliative Care Jan 2021Serious adverse event reporting guidelines have largely been developed for pharmaceutical trials. There is evidence that serious adverse events, such as psychological... (Review)
Review
What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care.
BACKGROUND/AIMS
Serious adverse event reporting guidelines have largely been developed for pharmaceutical trials. There is evidence that serious adverse events, such as psychological distress, can also occur in non-pharmaceutical trials. Managing serious adverse event reporting and monitoring in palliative care non-pharmaceutical trials can be particularly challenging. This is because patients living with advanced malignant or non-malignant disease have a high risk of hospitalisation and/or death as a result of progression of their disease rather than due to the trial intervention or procedures. This paper presents a number of recommendations for managing serious adverse event reporting that are drawn from two palliative care non-pharmacological trials.
METHODS
The recommendations were iteratively developed across a number of exemplar trials. This included examining national and international safety reporting guidance, reviewing serious adverse event reporting procedures from other pharmacological and non-pharmacological trials, a review of the literature and collaboration between the ACTION study team and Data Safety Monitoring Committee. These two groups included expertise in oncology, palliative care, statistics and medical ethics and this collaboration led to the development of serious adverse event reporting procedures.
RESULTS
The recommendations included; allowing adequate time at the study planning stage to develop serious adverse event reporting procedures, especially in multi-national studies or research naïve settings; reviewing the level of trial oversight required; defining what a serious adverse event is in your trial based on your study population; development and implementation of standard operating procedures and training; refining the reporting procedures during the trial if necessary and publishing serious adverse events in findings papers.
CONCLUSIONS
There is a need for researchers to share their experiences of managing this challenging aspect of trial conduct. This will ensure that the processes for managing serious adverse event reporting are continually refined and improved so optimising patient safety.
TRIAL REGISTRATION
ACTION trial registration number: ISRCTN63110516 (date of registration 03/10/2014). Namaste trial registration number: ISRCTN14948133 (date of registration 04/10/2017).
Topics: Hospice and Palliative Care Nursing; Humans; Palliative Care; Research Design
PubMed: 33472621
DOI: 10.1186/s12904-021-00714-5 -
BMC Medical Research Methodology Mar 2023Drug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to specific drug properties...
BACKGROUND
Drug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to specific drug properties (i.e., drug-host interaction). This concept is crucial for personalized drug safety but remains under-studied, primarily due to methodological challenges and limited data availability. By monitoring a large volume of adverse event reports in the postmarket stage, spontaneous adverse event reporting systems provide an unparalleled resource of information for adverse events and could be utilized to explore risk disparities of specific adverse events by age, sex, and other host factors. However, well-formulated statistical methods to formally address such risk disparities are currently lacking.
METHODS
In this paper, we present a statistical framework to explore spontaneous adverse event reporting databases for drug-host interactions and detect risk disparities in adverse drug events by various host factors, adapting methods for safety signal detection. We proposed four different methods, including likelihood ratio test, normal approximation test, and two tests using subgroup ratios. We applied our proposed methods to simulated data and Food and Drug Administration (FDA) Adverse Event Reporting Systems (FAERS) and explored sex-/age-disparities in reported liver events associated with specific drug classes.
RESULTS
The simulation result demonstrates that two tests (likelihood ratio, normal approximation) can detect disparities in adverse drug events associated with host factors while controlling the family wise error rate. Application to real data on drug liver toxicity shows that the proposed method can be used to detect drugs with unusually high level of disparity regarding a host factor (sex or age) for liver toxicity or to determine whether an adverse event demonstrates a significant unbalance regarding the host factor relative to other events for the drug.
CONCLUSION
Though spontaneous adverse event reporting databases require careful data processing and inference, the sheer size of the databases with diverse data from different countries provides unique resources for exploring various questions for drug safety that are otherwise impossible to address. Our proposed methods can be used to facilitate future investigation on drug-host interactions in drug toxicity using a large number of reported adverse events.
Topics: United States; Humans; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Pharmaceutical Preparations; Computer Simulation; Likelihood Functions; Databases, Factual
PubMed: 36973693
DOI: 10.1186/s12874-023-01885-w -
The Journal of Clinical and Aesthetic... Aug 2015The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse... (Review)
Review
BACKGROUND
The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use.
OBJECTIVE
A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment.
METHODS AND MEASUREMENTS
A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile.
RESULTS
Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study.
CONCLUSION
Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel.
PubMed: 26345379
DOI: No ID Found