Adverse Events Associated With Corticosteroid-Eluting Sinus Stents: A MAUDE Database Analysis

2021 ◽  
pp. 019459982110069
Author(s):  
Vishal Narwani ◽  
Sina J. Torabi ◽  
David A. Kasle ◽  
Rahul A. Patel ◽  
Michael Z. Lerner ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Fungal Infection ◽  
Postoperative Infection ◽  
Cross Sectional Study ◽  
Common Adverse Event ◽  
Sinus Surgery ◽  
Cross Sectional ◽  
The Us ◽  
User Facility

Objective Corticosteroid-eluting stents (CESs) are increasingly used after endoscopic sinus surgery to reduce the need for revision surgery, but their use is not without risks. The objective of this study is to describe adverse events related to CESs. Study Design Retrospective cross-sectional study. Setting The US Food and Drug Administration’s MAUDE database (2011-2020; Manufacturer and User Facility Device Experience). Methods The MAUDE database was queried for reports of adverse events involving the use of CESs approved by the Food and Drug Administration, including Propel, Propel Mini, Propel Contour, and Sinuva (Intersect ENT). Results There were 28 reported adverse events in total, with all events being related to the Propel family of stents and none related to Sinuva stents. Overall, 22 were categorized as patient-related adverse events and 6 as device-related events. The most common adverse event was related to postoperative infection, accounting for 39% (n = 11) of all complications. Four of these patients developed periorbital cellulitis, and 5 developed a fungal infection. The second-most common adverse event was migration of the stent, representing 21% of all complications (n = 6). Overall, 8 patients (29%) in our cohort required reintervention in the operating room, with subsequent removal of the CES. Conclusion The most commonly reported adverse events were postoperative infection, including multiple cases of fungal infection, followed by migration of the stent. An increased awareness of the complications associated with CESs can be used to better inform patients during the consenting process as well as surgeons in their surgical decision making.

scholarly journals Adverse Events Following COVISHIELD Vaccination Among Adult Population in Bangladesh

2021 ◽  
Author(s):  
Md. Musab Khalil ◽  
Khandker Mahbub-Uz-Zaman ◽  
As-Saba Hossain ◽  
Farid Ahmed ◽  
Md. Fazlul Karim Chowdhury ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adult Population ◽  
Cross Sectional Study ◽  
Common Adverse Event ◽  
Inclusion Criteria ◽  
Cross Sectional ◽  
Life Threatening ◽  
The Difference ◽  
Bangladeshi Population

AbstractThe study aimed to determine how frequently the adverse events of the COVISHIELD vaccine occur among the Bangladeshi population. This cross-sectional study was conducted at Sheikh Russel Gastroliver Institute and Hospital, Mohakhali, Dhaka, Bangladesh, in May 2021. The inclusion criteria were the adult populations who received the 2nd dose of the COVISHELD vaccine and had passed 28 days following the completion of the 2nd dose. Three hundred and five persons fulfilling the inclusion criteria were asked over the telephone—based on a predesigned questionnaire. The rates of adverse events were 54.1% and 41.3% after the 1st and 2nd dose of vaccine, respectively, and the difference was statistically significant (p < 0.001). Pain at the injection site was the most common adverse event (32.5% following the 1st dose and 27.9% following the 2nd dose). All of the symptoms were mild and lasted for about 2 days. Age and comorbidities were significantly associated with the adverse events (p < 0.001). Neither doses had any vaccine-related life-threatening adverse event nor had any symptoms related to vaccine-related blood clotting. Nineteen persons (6.2%) had been diagnosed with COVID-19 after the 1st dose of vaccination, and three (1%) persons had been diagnosed with COVID-19 after the 2nd dose of vaccination. As no significant life-threatening adverse event was observed, this study might help reduce the hesitancy for vaccination among the population and thus help reduce transmission of this highly contagious virus.

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

2021 ◽  
pp. 194589242110356
Author(s):  
Viraj N. Shah ◽  
Luke J. Pasick ◽  
Daniel A. Benito ◽  
Michael K. Ghiam ◽  
Christine D’Aguillo
Keyword(s):  
Adverse Events ◽  
Mometasone Furoate ◽  
Sinus Surgery ◽  
Comprehensive Understanding ◽  
Outflow Obstruction ◽  
The Us ◽  
User Facility ◽  
Drug Eluting ◽  
Headache Pain ◽  
Common Device

Background Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Objective To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Methods The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. Results After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). Conclusions PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.

Assessment of adverse events among cervical cancer patients at Kenyatta National Hospital

2021 ◽  
pp. 107815522110681
Author(s):  
Muthoni Kibaara ◽  
Amsalu Degu
Keyword(s):  
Cervical Cancer ◽  
Adverse Event ◽  
Adverse Events ◽  
Cancer Patients ◽  
Medical Records ◽  
Cross Sectional Study ◽  
National Hospital ◽  
Cross Sectional ◽  
Kenyatta National Hospital ◽  
Loss Of Appetite

Introduction Due to their cytotoxic nature, anticancer drugs and radiotherapy have the potential to cause toxic adverse events. As a result, they can increase the risk of morbidity and mortality. However, there was a lack of data among cervical cancer patients in our setting. Hence, this study was aimed to assess the prevalence of adverse events among cervical cancer patients at Kenyatta National Hospital. Methods A cross-sectional study design was employed among a consecutive sample of 151 adult cervical cancer patients. The data were collected by reviewing the medical records and interviewing the patients. The data were entered and analyzed using SPSS 27.0 software. The results were presented with frequency tables and graphs. Results A total of 214 adverse events (prevalence of 100%) were identified from 151 patients. The most common adverse events identified were ulcerated sores (52.8%), dysuria (7.5%), thrombocytopenia (5.6%), and loss of appetite (5.6%). The majority of the patients (80.8%) who had adverse events were on radiotherapy. As per the Naranjo causality assessment scale, the predominant (80.1%) proportion of the adverse event was a probable adverse event with a total score of 5–8. Besides, 15.9% of the adverse events had a possible causality. The present study also reported that 61.6% of patients with a probable adverse event were treated with radiotherapy. Conclusion The prevalence of adverse events among cervical patients was high in our setting. The predominant proportion of the adverse event was a probable adverse event and most of them were treated with radiotherapy.

scholarly journals HyPE study: hydroxychloroquine prophylaxis-related adverse events’ analysis among healthcare workers during COVID-19 pandemic: a rising public health concern

2020 ◽  
Vol 42 (3) ◽  
pp. 493-503 ◽  
Author(s):  
Bada Sharanappa Nagaraja ◽  
Kalhalli Narayanaswamy Ramesh ◽  
Debjyoti Dhar ◽  
Mahammad Samim Mondal ◽  
Treshita Dey ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Adverse Event ◽  
Adverse Events ◽  
Healthcare Workers ◽  
Cross Sectional Study ◽  
Health Concern ◽  
Cross Sectional ◽  
Web Based ◽  
Logistic Regression Models ◽  
Younger Age

Abstract Background The rising burden of Coronavirus disease (COVID-19) has led to the mass use of hydroxychloroquine by healthcare workers (HCWs). Adverse event profile of this drug when used as prophylaxis is not well known in the literature. Methods A retrospective, cross-sectional study was conducted across the country using semi-structured web-based questionnaire among COVID-19 negative and asymptomatic healthcare workers, taking hydroxychloroquine prophylaxis. Descriptive and multivariate logistic-regression models were applied for analysis. Results Of the 166 participants, at least one adverse event was experienced by 37.9% participants, gastrointestinal being the most common (30.7%). Risk was higher in participants &lt;40 years age (odd’s ratio (OR): 2.44, 95% confidence interval (CI): 1.18–5.05) and after first dose of hydroxychloroquine (51.2%, OR: 2.38, 95%CI: 1.17–4.84). Hydroxychloroquine prophylaxis was initiated without electrocardiography by 80.1% of HCWs. Only 21.6% of those with cardiovascular disease could get prior ECG. Conclusions A higher incidence of adverse events was observed when results were compared with studies involving patients on long-term hydroxychloroquine therapy. Younger age and first dose were associated with greater incidence of adverse events though all were self-limiting. Monitoring prior and during prophylaxis was inadequate even among those with cardiovascular disease and risk-factors. However, no serious cardiovascular events were reported.

scholarly journals Adverse events following COVID-19 virus vaccination in Japanese young population: The first cross-sectional study conducted by a questionnaire survey after the first-time-injection

2021 ◽  
Author(s):  
Marie Suehiro ◽  
Shinya Okubo ◽  
Kensuke Nakajima ◽  
Kosuke Kanda ◽  
Masanobu Hayakawa ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Questionnaire Survey ◽  
Cross Sectional Study ◽  
Young Population ◽  
Sectional Study ◽  
Multivariable Logistic Regression Model ◽  
Cross Sectional ◽  
Vaccination Site ◽  
First Time

A cross-sectional study was conducted to clarify the adverse events of COVID-19 vaccines in Japanese young population. The proportion of participants with adverse events at the vaccination site (immediately or within 30 minutes after vaccination) was 0.5%, and anaphylaxis occurred in one female student (0.03%). We analyzed 1,877 data obtained from a questionnaire survey of 1,993 vaccinated individuals. Eighty-two percent of participants complained of local adverse events. Injection site pain was the most common local adverse event (71%). Systemic adverse events occurred in 48% of participants. The most common adverse event was myalgia (34%). A multivariable logistic regression model was used to determine risk factors. Local adverse events were associated with sex (female) and allergy history, with odds ratios (ORs) (95% confidence interval [CI]) of 2.15 (1.69-2.73) and 1.73 (1.10-2.74), respectively. Systemic adverse events were associated with sex (female), age (<20 years old), allergy history, and history of adverse events with previous medications, with ORs (95% CI) of 2.49 (2.03-3.06), 1.80 (1.44-2.24), 1.39 (1.03-1.89), and 1.53 (1.02-2.29). The results of this study clarified for the first time that age less than 20 years is a risk factor for systemic adverse events from the COVID-19 Vaccine Moderna Intramuscular Injection. This information will give impacts on considering adverse events and its mechanisms in mRNA vaccination.

scholarly journals Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

2021 ◽  
Vol 18 (5) ◽  
pp. 2546
Author(s):  
Noriko Morioka ◽  
Masayo Kashiwagi
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Home Care ◽  
Process Of Care ◽  
Related Factors ◽  
Cross Sectional ◽  
Home Care Nursing ◽  
Number Of Patients ◽  
Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

scholarly journals Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Neuroleptic Malignant Syndrome ◽  
Antipsychotic Drug ◽  
Antipsychotic Drugs ◽  
Common Adverse Event ◽  
Drug Misuse ◽  
Large Databases ◽  
Chi Squared

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

scholarly journals Mucosal Eosinophilia and Neutrophilia Are Not Associated With QOL or Olfactory Function in Chronic Rhinosinusitis

2021 ◽  
pp. 194589242098743
Author(s):  
Nyssa F. Farrell ◽  
Jess C. Mace ◽  
David A. Sauer ◽  
Andrew J. Thomas ◽  
Mathew Geltzeiler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Nasal Polyposis ◽  
Cross Sectional Study ◽  
Olfactory Function ◽  
Sinus Surgery ◽  
Small Subset ◽  
Cross Sectional ◽  
Snot 22

Background Chronic rhinosinusitis (CRS) is often differentiated by histopathologic phenotypes (eosinophilic versus neutrophilic), which may impact disease severity measures and outcomes. As such, it has been suggested that counts of cellular elements be included as part of a standard pathological report following endoscopic sinus surgery (ESS). Objectives This cross-sectional study evaluated associations of mucosal eosinophilia and neutrophilia with measures of quality-of-life (QoL) and olfactory function. Methods Patients with medically refractory CRS completed the SNOT-22 survey and Brief Smell Identification Test (BSIT) at enrollment. In addition, baseline Lund-Mackay computed tomography (CT) and Lund-Kennedy endoscopy scores were collected. Ethmoid mucosa was biopsied during ESS and reviewed using microscopy to quantify densest infiltrate of eosinophils or neutrophils per high-powered-field (HPF). Eosinophilic CRS (eCRS) and neutrophilic CRS (nCRS), both with and without nasal polyposis (NP), were compared across SNOT-22 and BSIT scores. Results 77/168 patients demonstrated mucosal eosinophilia (eCRS) while a total of 42/168 patients demonstrated mucosal neutrophilia (nCRS). After adjusting for polyp status, 35/168 had eCRSsNP, 42/168 eCRSwNP, 75/168 non-eCRSsNP, 16/168 non-eCRSwNP. Additionally, 22/161 were noted to have nCRSsNP, 20/161 nCRSwNP, 84/161 non-nCRSwNP, and 35/161 non-nCRSsNP. A small subset of patients demonstrated both eosinophilia and neutrophilia: 14 CRSwNP and 7 CRSsNP. When evaluating average Lund-Mackay Scores (LMS), significant differences existed between non-eCRSsNP and eCRSsNP (p = 0.006). However, after controlling for nasal polyps, eosinophilia did not significantly associate with differences in the Lund-Kennedy Score. Neutrophilia did not significantly associate with any changes in LMS or LKS after controlling for NP. Eosinophilic and neutrophilic histopathologic subtypes did not significantly associate with differences in baseline SNOT-22 or BSIT measures after controlling for NP. Conclusion Neither the presence of mucosal eosinophilia nor mucosal neutrophilia demonstrated significant associations with SNOT-22 quality-of-life or BSIT olfactory function scores when controlling for comorbid nasal polyposis.

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