scholarly journals A Working Hypothesis Regarding Identical Pathomechanisms between Clinical Efficacy and Adverse Reaction of Clozapine via the Activation of Connexin43

2020 ◽  
Vol 21 (19) ◽  
pp. 7019 ◽  
Author(s):  
Motohiro Okada ◽  
Kouji Fukuyama ◽  
Takashi Shiroyama ◽  
Masahiko Murata
Keyword(s):  
Monitoring System ◽  
Clinical Efficacy ◽  
Adverse Reactions ◽  
Clinical Evidence ◽  
Antipsychotic Agent ◽  
World Health ◽  
Treatment Resistant ◽  
Global Database ◽  
The World ◽  
Severe Adverse Reactions

Clozapine (CLZ) is an approved antipsychotic agent for the medication of treatment-resistant schizophrenia but is also well known as one of the most toxic antipsychotics. Recently, the World Health Organization’s (WHO) global database (VigiBase) reported the relative lethality of severe adverse reactions of CLZ. Agranulocytosis is the most famous adverse CLZ reaction but is of lesser lethality compared with the other adverse drug reactions of CLZ. Unexpectedly, VigiBase indicated that the prevalence and relative lethality of pneumonia, cardiotoxicity, and seizures associated with CLZ were more serious than that of agranulocytosis. Therefore, haematological monitoring in CLZ patients monitoring system provided success in the prevention of lethal adverse events from CLZ-induced agranulocytosis. Hereafter, psychiatrists must amend the CLZ patients monitoring system to protect patients with treatment-resistant schizophrenia from severe adverse CLZ reactions, such as pneumonia, cardiotoxicity, and seizures, according to the clinical evidence and pathophysiology. In this review, we discuss the mechanisms of clinical efficacy and the adverse reactions of CLZ based on the accumulating pharmacodynamic findings of CLZ, including tripartite synaptic transmission, and we propose suggestions for amending the monitoring and medication of adverse CLZ reactions associated with pneumonia, cardiotoxicity, and seizures.

scholarly journals Clinical Efficacy of Combined Surgical Patient Safety System and the World Health Organization’s Checklists in Surgery

JAMA Surgery ◽  
2020 ◽  
Vol 155 (7) ◽  
pp. 562 ◽  
Author(s):  
Anette Storesund ◽  
Arvid Steinar Haugen ◽  
Hans Flaatten ◽  
Monica W. Nortvedt ◽  
Geir Egil Eide ◽  
...  
Keyword(s):  
Patient Safety ◽  
Clinical Efficacy ◽  
Safety System ◽  
World Health ◽  
Surgical Patient ◽  
The World

Clozapine: Serious Adverse Side Effects, Drug Interactions, and Other Complications of Therapy

1996 ◽  
Vol 9 (2) ◽  
pp. 118-129 ◽  
Author(s):  
Deanna M. Guith
Keyword(s):  
Side Effects ◽  
Health Care Professionals ◽  
Elderly Population ◽  
Adverse Reactions ◽  
Psychotic Disorders ◽  
Antipsychotic Agent ◽  
The Elderly ◽  
Pharmacological Properties ◽  
Treatment Resistant ◽  
Clozapine Therapy

Clozapine (Clozaril®, Sandoz, East Hanover, NJ), an atypical antipsychotic agent with pharmacological properties considerably different from standard neuroleptics, has been found to be of great benefit especially to patients with treatment-resistant psychotic disorders. However, it is these unique pharmacological properties that have also been associated with mul tiple side effects ranging from the relatively benign (ie, sialorrhea during sleep, dizziness) to the potentially fatal (ie, agranulocytosis, seizures, and respiratory depression) which have limited its use. These untoward side effects are particularly problematic in the elderly population who often have concomitant medi cal illnesses requiring multiple medication regimens, including psychotropics that may interact with cloza pine (ie, benzodiazepines, cimetidine, fluoxetine). Because even the most benign of side effects has the potential of becoming fatal in certain circumstances if left unaddressed, it is imperative for patients, clinicians, pharmacists, and all health care professionals to be aware of adverse reactions and possible complica tions of clozapine therapy to prevent significant morbidity and mortality. Copyright © 1996 by W.B. Saunders Company

scholarly journals WBSN based safe lifestyle: A case study of heartrate monitoring system

2020 ◽  
Vol 10 (3) ◽  
pp. 2296
Author(s):  
Vidhyotma GANDHI ◽  
Jaiteg Singh
Keyword(s):  
Monitoring System ◽  
The Body ◽  
World Health ◽  
Health Statistics ◽  
Heart Attacks ◽  
The World ◽  
Cardiac Condition ◽  
Young Subjects ◽  
Monitoring Algorithm

A Heart is the vital organ of the body. According to the “world health statistics, 2017” by WHO, about 460,000 people die due to fatal heart attacks every year. To reduce the death rate due to fatal heart attacks and malfunctioning of the cardiovascular system, this paper proposed a Wireless Body Sensor Network (WBSN) based, portable, easily affordable, miniatured, accurate “Heartrate Monitoring System (HMS)”. HMS can be used to regularly examine the cardiac condition at home or hospital to avoid or early detection of any serious condition. Heartrate Monitoring Algorithm (HMA) was designed to observe the spread heartbeat spectrum and worked at the backend of HMS. A case study was performed for forty healthy young subjects. Each subject data was computed for (sub) ̅-3S_d<sub<(sub) ̅+3S_d . All subjects’ 99% data lie in the custom range. The results produced by HMS was the same as the previous medical record of subjects.

scholarly journals Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance Database

Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 393
Author(s):  
Mansour Tobaiqy ◽  
Hajer Elkout ◽  
Katie MacLure
Keyword(s):  
Adverse Reactions ◽  
Blood Clot ◽  
Descriptive Study ◽  
World Health ◽  
European Medicines Agency ◽  
Research Groups ◽  
Spontaneous Reports ◽  
The World ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early in December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford–AstraZeneca vaccine amid reports of blood clot events and the death of a vaccinated person, despite the European Medicines Agency (EMA) and the World Health Organization’s assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with the Oxford–AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports, of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to pulmonary embolism; one fatality to thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events The EMA’s Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients’ characteristics and comorbidities, may enable assessment of the causality with higher specificity.

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 International Drug Safety Monitoring

2019 ◽  
Vol 7 (3) ◽  
pp. 120-126 ◽  
Author(s):  
A. S. Kazakov ◽  
E. V. Shubnikova ◽  
M. A. Darmostukova ◽  
I. I. Snegireva ◽  
G. V. Kutekhova ◽  
...  
Keyword(s):  
Drug Safety ◽  
Medical Information ◽  
Safety Monitoring ◽  
World Health ◽  
Medicinal Products ◽  
Global Database ◽  
National Monitoring ◽  
The World ◽  
Drug Safety Monitoring ◽  
Health Organization

In the 1960s, following the Thalidomide Disaster, the World Health Organization (WHO) initiated the development of an international drug safety monitoring programme. The objectives of this WHO programme are to improve the quality and safety of pharmaceuticals, and to support public health programmes by providing information for effective assessment of the risk-benefit ratio of medicinal products. The paper outlines the main focus areas of the programme and the mechanism of interaction between the countries involved. It summarises the functions of the WHO Collaborating Centre for International Drug Monitoring located in Uppsala, namely, accumulation and assessment of data on efficacy, inefficacy and risks of medicinal products, which are communicated by the participating countries, and provision of reliable and coherent data to specialists. The paper provides a review of online resources and methods used by VigiBase — global database of adverse drug reactions — that make it possible to search and analyse the data statistically. It describes the functions of the national monitoring centres located in different regions, and their interaction with the WHO. The dissemination of objective and reliable medical information throughout the world, promotion of pharmacovigilance as a science, creation of international partnerships and pooling of expertise from different countries allow for a significant improvement in the safety of pharmacotherapy.

scholarly journals Serious adverse reactions associated with ivermectin: A systematic pharmacovigilance study in sub-Saharan Africa and in the rest of the World

2021 ◽  
Vol 15 (4) ◽  
pp. e0009354
Author(s):  
Jérémy T. Campillo ◽  
Michel Boussinesq ◽  
Sébastien Bertout ◽  
Jean-Luc Faillie ◽  
Cédric B. Chesnais
Keyword(s):  
Drug Administration ◽  
Adverse Reactions ◽  
Case Reports ◽  
Individual Case ◽  
Sub Saharan Africa ◽  
World Health ◽  
The World ◽  
Excellent Safety Profile ◽  
Sub Saharan ◽  
First Time

Background Ivermectin is known to cause severe encephalopathies in subjects infected with loiasis, an endemic parasite in Sub-Saharan Africa (SSA). In addition, case reports have described ivermectin-related serious adverse drug reactions (sADRs) such as toxidermias, hepatic and renal disorders. The aim of this study was to identify suspected sADRs reported after ivermectin administration in VigiBase, the World Health Organization’s global individual case safety reports database and analyze their frequency relative to the frequency of these events after other antinematodal drugs reported in SSA and other areas of the world (ROW). Methods All antinematodal-related sADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate nervous, cutaneous, psychiatric, respiratory, renal, hepatic and cardiac suspected sADRs reported after ivermectin and benzimidazole drug administration across the world, in SSA and RoW. Principal findings 2041 post-ivermectin or post-benzimidazole suspected sADRs were identified including 667 after ivermectin exposure (208 in SSA and 459 in the RoW). We found an increased reporting for toxidermias, encephalopathies, confusional disorders after ivermectin compared to benzimidazole drug administration. Encephalopathies were not only reported from SSA but also from the RoW (adjusted reporting odds ratios [aROR] 6.30, 95% confidence interval: 2.68–14.8), highlighting the fact these types of sADR occur outside loiasis endemic regions. Conclusion We described for the first time suspected sADRs associated with ivermectin exposure according to geographical origin. While our results do not put in question ivermectin’s excellent safety profile, they show that as for all drugs, appropriate pharmacovigilance for adverse reactions is indicated.

scholarly journals Monoclonal antibodies in COVID-19 management: a scoping review

2021 ◽  
Vol 10 (10) ◽  
pp. 1215
Author(s):  
Umayal Adaikkalavan ◽  
Jeeja Mathummal Cherumanalil ◽  
Salwa Pannikkottuthodi ◽  
Hasna Poovancheri
Keyword(s):  
Monoclonal Antibodies ◽  
Scoping Review ◽  
Adverse Reactions ◽  
Therapeutic Agents ◽  
World Health ◽  
Effective Control ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The World ◽  
Health Organization

Coronavirus disease 2019 (COVID-19) was declared as pandemic on March 11th 2020 by the world health organization (WHO). Vaccination is for preventing COVID-19 morbidity but when people are infected, treatment is required and even after one and half years the effective cure is yet to be discovered. In this context monoclonal antibodies (mAbs) are promising innovative therapeutic agents in controlling COVID-19 infection. Researchers have found more than 50 mAbs against COVID-19 and they are at different stages of development.  Scientists are pacing the research on mAbs. mAbs are innovative therapeutic agents in this context a scoping narrative review was done. At present we have evidences from numerous randomized controlled trials (RCT) on mAbs in effective control of respiratory and coagulation related complications due to COVID-19 infection. Many have got emergency use approval and few of which were withdrawn due to absence of enough evidences or adverse reactions. Examples are bamlanivimab, etesevimab, casirivimab and imdevimab. Other than these many investigational (mAbs) are under scrutiny. With the current evidences the article will give an insight to new and repurposed mAbs which are still under investigation in the management of COVID-19 infections.

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