scholarly journals Coadministration of tizanidine and ciprofloxacin: a retrospective analysis of the WHO pharmacovigilance database

2021 ◽  
Author(s):  
Annette Rudolph ◽  
Hendrike Dahmke ◽  
Hugo Kupferschmidt ◽  
Andrea Burden ◽  
Stefan Weiler
Keyword(s):  
Real World ◽  
Safety Issue ◽  
Demographic Data ◽  
Fatal Outcome ◽  
Individual Case ◽  
World Health ◽  
Global Database ◽  
The Usa ◽  
Pharmacovigilance Database ◽  
The Impact

Abstract Purpose Tizanidine, an alpha-adrenergic substance with antinociceptive and antihypertensive effects, is extensively metabolized via cytochrome P450 (CYP) 1A2. Therefore, coadministration with potent CYP1A2 inhibitors, such as ciprofloxacin, is contraindicated. However, both drugs are broadly utilized in various countries. Their concomitant use bears an inherent high risk for clinically significant symptoms, especially in multimorbid patients experiencing polypharmacy. This study aims to investigate the impact of coadministration of tizanidine and ciprofloxacin using real-world pharmacovigilance data and to raise awareness of this potentially underestimated safety issue. Methods We conducted a retrospective study including Individual Case Safety Reports (ICSR) registered until March 1, 2017, in the World Health Organization (WHO) global database. Demographic data, drug administration information, the course of the adverse drug reaction (ADR), its severity, and outcomes were analyzed for cases reporting ciprofloxacin comedication. Results In 91 (2.0%) of the identified 4192 worldwide ICSR on tizanidine, coadministration of ciprofloxacin was reported. Most of the patients were female (n = 59, 64.8%) with a median age of 54 years (range 13–85 years). The countries contributing most reports were the USA (n = 54, 59.3%) and Switzerland (n = 16, 17.6%). ADRs reported most often affected the nervous system and the cardiac function, especially with large tizanidine doses or drugs with CNS and cardiovascular depressant effects. In two cases, a fatal outcome was reported. Conclusion Despite the existing formal contraindication, the concomitant use of tizanidine and ciprofloxacin can be observed in real-world clinical practice. Reactions mainly affected the central nervous and the cardiovascular system resulting in potentially severe adverse effects. The concomitant use of tizanidine and ciprofloxacin should absolutely be avoided.

scholarly journals Envisioning a McGill University lifelong learning and living (L4) community

2018 ◽  
Vol 5 (1) ◽  
Author(s):  
Ruth Allan Rigby ◽  
Marlene Chan ◽  
April L. Colosimo
Keyword(s):  
Lifelong Learning ◽  
Health Care Professionals ◽  
Interdisciplinary Collaboration ◽  
Learning Experience ◽  
Well Being ◽  
World Health ◽  
Individual Student ◽  
The Usa ◽  
Intellectual Capacity ◽  
The Impact

Lifelong learning and cognitive resilience are integral to a changing 21st century education paradigm for learners of all ages, as they are for health and well being of the individual student and wider community. Neuroscience in particular is continually making inroads on the impact that learning has on the brain and the interrelationships between body and mind that help to maintain physical and intellectual capacity over a lifetime. There is a long-standing community dedicated to sustainable lifelong learning on campus, the McGill Community for Lifelong Learning (MCLL). There are also worldwide efforts underway to promote lifelong learning in the context of age friendly cities under the auspices of UNESCO and the World Health Organization. Moreover, the international network of Age Friendly Universities, Lifelong Learning Institutes and over 200 University Based Retirement Communities (UBRCs) in the USA offer resources, guidelines, operating principles and research for building unique and innovative local responses to the changing demographics, increased cultural diversity and technological changes in education futures for learners in a given community. The poster will highlight national and international research initiatives and networks to enhance well-being and mental health through lifelong learning.Different L4 community options will be explored, building on MCLL’s peer learning experience over the past 27 years. It will reflect opportunities for interdisciplinary collaboration with university and wider Montreal community stakeholders, including health care professionals, caregivers, and educators.The poster will demonstrate that a lifelong learning approach to whole person care has the potential to be transformative. 

scholarly journals Comunicando el Cambio Climático desde un Encuadre de Salud = Communicating Climate Change from a Health Frame

2018 ◽  
Vol 9 (1) ◽  
pp. 99
Author(s):  
José Daniel Cáceres Pinto
Keyword(s):  
Climate Change ◽  
International Organizations ◽  
Water Distribution ◽  
World Health ◽  
Success Story ◽  
Social Actors ◽  
Raising Awareness ◽  
The Usa ◽  
Health Organization ◽  
The Impact

Resumen: Organismos internacionales coinciden que el cambio climático representa una amenaza para el ser humano, particularmente para su salud. Entidades como la Organización Mundial de la Salud (OMS) y voces de la comunidad científica han venido advirtiendo sobre los efectos que las distor­siones climáticas están teniendo sobre la propagación de enfermedades cuyos vectores dependen de su entorno. Sectores vitales para el desarrollo social como la distribución del agua, la agricultu­ra, y la sanidad pública se están viendo cada vez más amenazados por la vorágine climatológica. Sin embargo, persiste una indiferencia silenciosa en diferentes segmentos sociales que consideran el Cambio Climático como un problema abstracto o simplemente algo muy sobre sus capacidades de resolución. Desactivar este desafecto, concienciar a la población general y movilizar a la toma de acción han sido unos de los retos que diversos actores sociales han asumido. Uno de los casos de éxito que más llama la atención ha sido el uso de encuadres de salud. El siguiente artículo di­secciona el impacto que el Cambio Climático tiene y presenta el caso sobre el uso de la promoción de la salud en EEUU para concienciar sobre la problemática ambiental.Palabras clave: Salud; Cambio Climático; encuadres; mensaje.Abstract: International organizations agree that climate change poses a threat to the human being, parti­cularly to his health. Entities such as the World Health Organization (WHO) and voices from the scientific community have been warning about the effects the climatic distortions are having on the propagation of illnesses which vectors depend on their surroundings. Vital sectors for social development such as water distribution, agriculture, and public health are progressively seeing themselves more threatened by the climatic maelstrom. Nevertheless, an indifferent silence per­sists in different social segments who consider Climate change as an abstract problem or simply something out of their reach to resolve. Deactivating this disaffection, raising awareness in the ge­neral population and mobilize to take action have been some of the challenges social actors have undertaken. One particular success story that grabs the attention is the use of health frames. The following article dissects the impact that Climate Change has and presents the case of the use of health promotion in the USA to raise awareness about the environmental problem.Keywords: Health; Climate Change; Frames; Message.

Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database

2020 ◽  
Author(s):  
Joachim Alexandre ◽  
Joe-Elie Salem ◽  
Javid Moslehi ◽  
Marion Sassier ◽  
Camille Ropert ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticancer Drugs ◽  
Kinase Inhibitors ◽  
Descriptive Analysis ◽  
Individual Case ◽  
World Health ◽  
European Medicines Agency ◽  
Individual Case Safety Report ◽  
Pharmacovigilance Database ◽  
Haematologic Malignancies

Abstract Aims The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF. Methods and results A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody. Conclusion Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.

scholarly journals Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ellen M. McCreedy ◽  
Roee Gutman ◽  
Rosa Baier ◽  
James L. Rudolph ◽  
Kali S. Thomas ◽  
...  
Keyword(s):  
Nursing Home ◽  
Real World ◽  
Implementation Strategies ◽  
Trial Registration ◽  
World Health ◽  
Secondary Outcome ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact ◽  
Adaptive Trial

Abstract Background Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. Methods We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents’ racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. Discussion This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2a} Trial registration ClinicalTrials.govNCT03821844. Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.

IL-4/13 Blockade and sleep-related adverse drug reactions in over 37,000 Dupilumab reports from the World Health Organization Individual Case Safety reporting pharmacovigilance database (VigiBase™): a big data and machine learning analysis (Preprint)

2021 ◽  
Author(s):  
Roobaea Alroobaea ◽  
Saeed Rubaiee ◽  
Abdulkader S. Hanbazazah ◽  
Haitham Jahrami ◽  
Sergio Garbarino ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Individual Case ◽  
World Health ◽  
Drug Reactions ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization ◽  
Sleep Deficit

BACKGROUND Atopic dermatitis displays a relevant sleep burden sustained by clinical (i.e., itch), psychological (i.e., inadequate coping strategies) and therapeutic (i.e. frequent loss of drug response) triggers. Dupilumab, the first biologic approved for atopic dermatitis, showed excellent effects on improving pruritus and sleep after only two weeks of treatment but, in some cases, may have paradoxical effects. OBJECTIVE The rate of sleep-related side-effects remains unknown. More specifically, adverse-drug reactions (ADRs) related to dupilumab have been investigated during the safety phase of randomized clinical trials or in small retrospective epidemiological surveys, but little is known about sleep-related ADRs in real-life settings. Therefore, we took advantage of a global large-scale pharmacovigilance database, carrying out a comprehensive data mining analysis to look at different sleep-related ADRs reported among patients under anti IL-4/13 therapy. METHODS We analysed individual case study reports (ICSRs) in VigiBase, the World Health Organization (WHO) global pharmacovigilance database of ADRs collected by national drug authorities in >140 countries (>90% of the world population). We looked for patterns of potentially sleep-related ADRs and we applied a disproportionality analysis based on Bayesian Confidence Propagation Neural Network (BCPNN). A meta-analytical approach was used to synthesize the overall effect size of sleep-related ADRs potentially associated to Dupilumab administration. RESULTS From inception up to March 9, 2021, 94,065 ADRs from 37,848 unique reports were included and analyzed in the present paper: 1,294 of them (1.4%) concerned sleep disturbances (n=27). Most of sleep-related complaints were generic sleep disorders (n=630), followed by insomnia (n=312), somnolence (n=81), lethargy (n=60), night sweats (n=30), middle insomnia (n=39), hypersomnia (n=25), poor quality sleep (n=21), initial insomnia (n=17), sleep apnoea syndrome (n=13), nightmares (n=11) and sleep deficit (n=11). Interestingly, restlessness and restless leg syndrome, nocturnal dyspnoea, narcolepsy and bruxism were reported in 7, 6, 5, 4 and 3 cases, respectively. Only sleep deficit (OR 15.67 [CrI 8.61-28.51]; IC 3.24 [CrI 2.26-3.97]), generic sleep disorder (OR 6.22 [CrI 5.74-6.73]; IC 2.60 [CrI 2.48-2.71]), and nocturnal dyspnoea (OR 3.68 [CrI 1.53-8.87]; IC 1.56 [CrI 0.03-2.56]) achieved the statistical significance threshold. CONCLUSIONS In this work, we identified over 37,000 unique case-reports of Dupilumab side-effects reported on the WHO pharmacovigilance database. We specifically categorised those related to sleep issues, which were 1,294. Our findings from large numbers of cases provide data supporting the clinical observations that Dupilumab is usually effective in improving sleep quality and sleep disturbances/impairments but sometimes may impair circadian rhythm and sleep. Further work is needed to closely scrutinise the impact of Dupilumab on sleep, in terms of underlying mechanisms, and to better understand residual sleep disorders in patients with atopic dermatitis and other allergic diseases treated with Dupilumab. Thus, sleep monitoring may be helpful for dermatologists in managing atopic dermatitis patients treated with dupilumab. The limitations of spontaneous reporting systems including underreporting and reporting bias, heterogeneity of sources and impossibility to infer any causal relationship merit consideration and further research is needed.

Abstract 14661: High Sensitive Troponin Elevation Pattern in Covid-19 Era

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Alessandro Maino ◽  
Enrico Di Stasio ◽  
Maria Chiara Grimaldi ◽  
Luigi Cappannoli ◽  
Erica Rocco ◽  
...  
Keyword(s):  
Disease Severity ◽  
Demographic Data ◽  
Fatal Outcome ◽  
Treatment Strategies ◽  
High Sensitivity ◽  
Laboratory Findings ◽  
Reference Limit ◽  
Care Information ◽  
Upper Reference Limit ◽  
The Impact

Introduction: Coronavirus disease 2019 (COVID-19) is a pandemic disease that has caused a public health emergency due to its high rapid spread, to the high mortality rate, and the high percentage of patients requiring hospitalization and intensive care . Information regarding the impact of cardiovascular complication on fatal outcome is scarce. Purpose: To compare the levels of hs-Tn between patients affected by SARS-CoV-2 admitted to our hospital in the period February 20-April 9, 2020 versus the general population COVID free. Furthermore, we studied the dependence of hs-Tn levels in SARS-CoV-2 patients on disease severity and on other epidemiological, clinical and laboratory parameters. Methods: This retrospective single-center study analyzed all patients in whom hs-TnI was determined at the Policlinico A.Gemelli (Rome, Italy) from 20 February 2020 to 09 April 2020. One hundred-seventy of these patients received SARS-CoV-2 diagnosis. Demographic data, laboratory findings, comorbidities, and treatments were collected and analyzed in patients with COVID 19. Results: In our study, the population affected by SARS-CoV-2 (n=170) showed a significant association between disease severity and troponin levels (median [range] = 4.0 [<2.4-227.0], 13.5 [<2.4-545.0] and 34.0 [<2.4-45345.0], p<0.001, for mild, severe and critical state, respectively). Moreover, 27 subjects out of 170 (16%) showed high sensitivity troponin values higher than the 99 percentile upper reference limit stratified among previously defined severity classes as follows n=2 (2.4%), n=7 (15.9%) and n=18 (45.0%), respectively. Conclusions: The distribution of the troponin values greater than the cut-off in the SARS-CoV-2 population indicates a myocardial suffering independently related to COVID19 infection. This phenomenon may partially explain the high risk of adverse outcome in COVID-19 patients with underlying CVD. Therefore, it may be reasonable to triage patients with COVID-19 according to the presence of underlying CVD and evidence of myocardial injury for prioritized and personalized treatment strategies.

scholarly journals Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study

2020 ◽  
Vol 13 (10) ◽  
pp. 325
Author(s):  
Marc Hilmi ◽  
Stéphane Ederhy ◽  
Xavier Waintraub ◽  
Christian Funck-Brentano ◽  
Ariel Cohen ◽  
...  
Keyword(s):  
Trial Design ◽  
Clinical Trial Design ◽  
Individual Case ◽  
Cardiovascular Death ◽  
World Health ◽  
Information Component ◽  
Global Database ◽  
Adr Reporting ◽  
Pericardial Diseases ◽  
The World

Background: Gemcitabine is a nucleoside analog, widely used either alone or in combination, for the treatment of multiple cancers. However, gemcitabine may also be associated with cardiovascular adverse-drug-reactions (CV-ADR). Methods: First, we searched for all cases of cardiotoxicity associated with gemcitabine, published in MEDLINE on 30 May 2019. Then, we used VigiBase, the World Health Organization’s global database of individual case safety reports, to compare CV-ADR reporting associated with gemcitabine against the full database between inception and 1 April 2019. We used the information component (IC), an indicator value for disproportionate Bayesian reporting. A positive lower end of the 95% credibility interval for the IC (IC025) ≥ 0, is deemed significant. Results: In VigiBase, 46,898 reports were associated with gemcitabine on a total of 18,908,940 in the full database. Gemcitabine was associated with higher reporting for myocardial ischemia (MI, n: 119), pericardial diseases (n: 164), supraventricular arrhythmias (SVA, n: 308) and heart failure (HF, n: 484) versus full database with IC025 ranging between 0.40 and 2.81. CV-ADR were associated with cardiovascular death in up to 17% of cases. Conclusion: Treatment with gemcitabine is associated with potentially lethal CV-ADRs, including MI, pericardial diseases, SVA and HF. These events should be considered in patient care and clinical trial design.

scholarly journals Smallpox in the Post-Eradication Era

Viruses ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 138 ◽  
Author(s):  
Hermann Meyer ◽  
Rosina Ehmann ◽  
Geoffrey L. Smith
Keyword(s):  
Public Health ◽  
Human Population ◽  
Health Benefit ◽  
World Health Organisation ◽  
World Health ◽  
Viral Spread ◽  
The World ◽  
The Usa ◽  
The Impact

Widespread vaccination programmes led to the global eradication of smallpox, which was certified by the World Health Organisation (WHO), and, since 1978, there has been no case of smallpox anywhere in the world. However, the viable variola virus (VARV), the causative agent of smallpox, is still kept in two maximum security laboratories in Russia and the USA. Despite the eradication of the disease smallpox, clandestine stocks of VARV may exist. In a rapidly changing world, the impact of an intentional VARV release in the human population would nowadays result in a public health emergency of global concern: vaccination programmes were abolished, the percentage of immunosuppressed individuals in the human population is higher, and an increased intercontinental air travel allows for the rapid viral spread of diseases around the world. The WHO has authorised the temporary retention of VARV to enable essential research for public health benefit to take place. This work aims to develop diagnostic tests, antiviral drugs, and safer vaccines. Advances in synthetic biology have made it possible to produce infectious poxvirus particles from chemicals in vitro so that it is now possible to reconstruct VARV. The status of smallpox in the post-eradication era is reviewed.

Entrepreneurship education: a need for reflection, real-world experience and action

2015 ◽  
Vol 21 (5) ◽  
pp. 690-708 ◽  
Author(s):  
Hemant Kassean ◽  
Jeff Vanevenhoven ◽  
Eric Liguori ◽  
Doan E. Winkel
Keyword(s):  
Undergraduate Students ◽  
Real World ◽  
Social Cognitive ◽  
Entrepreneurship Education ◽  
Economic Benefits ◽  
Web Based ◽  
Content Type ◽  
Classroom Activities ◽  
The Usa ◽  
The Impact

Purpose – The purpose of this paper is to explore the impact of common undergraduate entrepreneurship classroom activities on students’ motivational processes related to entrepreneurial careers. Design/methodology/approach – In total, 700 undergraduate students from a variety of majors at a large midwestern university in the USA were invited to take a web-based survey. They were asked to indicate which experiential activities they would participate/were participating in as part of their program. Findings – The findings show that students’ entrepreneurial self-efficacy (ESE) is a driving force in classroom activities enhancing students’ intentions. However, the authors also found that the type of classroom activities that are common in entrepreneurship education negatively impact students’ ESE. Research limitations/implications – The generalizability is limited to the US region and the link from intention to behavior goes untested, but results strongly supported the adoption of social cognitive career theory to the entrepreneurship domain. Practical implications – This study lends support to the argument that promoting the learning process in entrepreneurship education should focus on real-world experience, action, and reflective processes to engage students in authentic learning, which should lead to greater entrepreneurial abilities and propensity, and eventually to enhanced entrepreneurial performance, which benefits individuals and societies. Social implications – This study suggests that the goals and pedagogical approaches to teaching entrepreneurship are issues that educators may need to revisit and update if the economic benefits of entrepreneurship are to be fully realized. Originality/value – While the relationship between entrepreneurship education and entrepreneurship activity is well documented in extant literature, this study found that activities that are common in entrepreneurship education may negatively impact students’ ESE and need to be further explored.

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