scholarly journals DIC-Like Syndrome Following Administration of ChAdOx1 nCov-19 Vaccination

Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1046
Author(s):  
Gerardo Casucci ◽  
Domenico Acanfora
Keyword(s):  
Side Effects ◽  
Disseminated Intravascular Coagulation ◽  
Adverse Reactions ◽  
Thrombus Formation ◽  
European Countries ◽  
European Medicines Agency ◽  
Safety Committee ◽  
Vectored Vaccine ◽  
Short Time ◽  
Prompt Diagnosis

In recent weeks, adverse reactions have been reported after administration of Oxford–AstraZeneca chimpanzee adenovirus vectored vaccine ChAdOx1 nCoV-19 (AZD1222), in particular thrombus formation, which has led several European Countries to discontinue administration of this vaccine. On March 8, 2021, the European Medicines Agency Safety Committee did not confirm this probable association. We report the case of a patient who developed disseminated intravascular coagulation after the first dose of Oxford-Astra Zeneca vaccine, which resolved in a few days with the administration of dexamethasone and enoxaparin. This work demonstrates the safety of the Oxford-Astra Zeneca vaccine and that any development of side effects can be easily managed with a prompt diagnosis and in a short time with a few commonly used drugs.

scholarly journals The Safety of COVID-19 Vaccinations—We Should Rethink the Policy

Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 693
Author(s):  
Harald Walach ◽  
Rainer J. Klement ◽  
Wouter Aukema
Keyword(s):  
Side Effects ◽  
Confidence Interval ◽  
Field Study ◽  
Adverse Reactions ◽  
Safety Data ◽  
European Medicines Agency ◽  
Point Estimate ◽  
Drug Reactions ◽  
Vaccination Policy ◽  
Risks And Benefits

Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

scholarly journals Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines

Diagnostics ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 579
Author(s):  
Bogdan Doroftei ◽  
Alin Ciobica ◽  
Ovidiu-Dumitru Ilie ◽  
Radu Maftei ◽  
Ciprian Ilea
Keyword(s):  
Side Effects ◽  
Severe Acute Respiratory Syndrome ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Age Group ◽  
Efficacy And Safety ◽  
Short Time ◽  
Dose Dependent ◽  
Severe Adverse Reactions ◽  
Age And Sex

Severe Acute Respiratory Syndrome Coronavirus 2 is a novel strain of human beta-coronavirus that has produced over two million deaths and affected one hundred million individuals worldwide. As all the proposed drugs proved to be unstable, inducing side effects, the need to develop a vaccine crystallized in a short time. As a result, we searched the databases for articles in which the authors reported the efficacy and safety of the use of several vaccines vaccines by sex, age group, and frequency of adverse reactions. We identified a total of 19 relevant articles that were discussed throughout this manuscript. We concluded that from all eleven vaccines, three had an efficacy >90% (Pfizer–BioNTech (~95%), Moderna (~94%), and Sputnik V (~92%)) except for Oxford–AstraZeneca (~81%). However, Moderna, Sputnik V, and Oxford–AstraZeneca also alleviate severe adverse reactions, whereas in Pfizer–BioNTech this was not revealed. The remaining five (Convidicea (AD5-nCOV); Johnson & Johnson (Ad26.COV2.S); Sinopharm (BBIBP-CorV); Covaxin (BBV152), and Sinovac (CoronaVac)) were discussed based on their immunogenicity, and safety reported by the recipients since only phases 1 and 2 were conducted without clear evidence published regarding their efficacy. CoviVac and EpiVacCorona have just been approved, which is why no published article could be found. All adverse events reported following the administration of one of the four vaccines ranged from mild to moderate; limited exceptions in which the patients either developed severe forms or died, because most effects were dose-dependent. It can be concluded that aforementioned vaccines are efficient and safe, regardless of age and sex, being well-tolerated by the recipients.

Sulfinpyrazone or Acetylsalicylic Acid to Prevent Postoperative Thrombus Formation in Arteriovenous Fistulas of Haemodialysis Patients

1979 ◽  
Author(s):  
F Albert ◽  
U Schmidt
Keyword(s):  
Side Effects ◽  
Acetylsalicylic Acid ◽  
Thrombus Formation ◽  
Significant Inhibition ◽  
High Rate ◽  
Controlled Clinical Trial ◽  
Arteriovenous Fistulas ◽  
Arteriovenous Shunts ◽  
Gastrointestinal Side Effects ◽  
Antithrombotic Efficacy

The effect of sulfinpyrazone (200 mg three times a day) and acetylsalicylic acid (500 mg three times a day) on the incidence of thrombosis of arteriovenous shunts was investigated in a controlled clinical trial. In 36 patients with chronic renal failure scheduled to begin haemodialysis the same operating team constructed a subcutaneous fistula in the distal forearm. During the first six weeks after the operation the antithrombotic efficacy proved to be good for both substances. No differences of thrombotic events between the two treatment groups were statistically significant. But in contrast to acetylsalicylic acid sulfinpyrazone made no significant inhibition of platelet - aggregation; sulfinpyrazone probably will prevent the clot formation by prolonging the shortened platelet survival in uraemic patients. In a high rate of patients given acetylsalicylic acid (10 out of 17) there were local bleeding and gastrointestinal side effects. In consequence we should prefer sulfinpyrazone, because in the sulfinpyrazone group side effects were minimal and in none patient withdrawal from the study was necessitated.

scholarly journals Recent advances in understanding NRF2 as a druggable target: development of pro-electrophilic and non-covalent NRF2 activators to overcome systemic side effects of electrophilic drugs like dimethyl fumarate

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 2138 ◽  
Author(s):  
Takumi Satoh ◽  
Stuart Lipton
Keyword(s):  
Side Effects ◽  
Specific Interaction ◽  
Dimethyl Fumarate ◽  
Carnosic Acid ◽  
European Medicines Agency ◽  
Related Factor ◽  
Inflammatory Phase ◽  
First Case ◽  
Systemic Side Effects ◽  
Transcriptional Pathway

Dimethyl fumarate (DMF) is an electrophilic compound previously called BG-12 and marketed under the name Tecfidera®. It was approved in 2013 by the US Food and Drug Administration and the European Medicines Agency for the treatment of relapsing multiple sclerosis. One mechanism of action of DMF is stimulation of the nuclear factor erythroid 2-related factor 2 (NRF2) transcriptional pathway that induces anti-oxidant and anti-inflammatory phase II enzymes to prevent chronic neurodegeneration. However, electrophiles such as DMF also produce severe systemic side effects, in part due to non-specific S-alkylation of cysteine thiols and resulting depletion of glutathione. This mini-review presents the present status and future strategy for NRF2 activators designed to avoid these side effects. Two modes of chemical reaction leading to NRF2 activation are considered here. The first mode is S-alkylation (covalent reaction) of thiols in Kelch-like ECH-associated protein 1 (KEAP1), which interacts with NRF2. The second mechanism involves non-covalent pharmacological inhibition of protein-protein interactions, in particular domain-specific interaction between NRF2 and KEAP1 or other repressor proteins involved in this transcriptional pathway. There have been significant advances in drug development using both of these mechanisms that can potentially avoid the systemic side effects of electrophilic compounds. In the first case concerning covalent reaction with KEAP1, monomethyl fumarate and monoethyl fumarate appear to represent safer derivatives of DMF. In a second approach, pro-electrophilic drugs, such as carnosic acid from the herb Rosmarinus officinalis, can be used as a safe pro-drug of an electrophilic compound. Concerning non-covalent activation of NRF2, drugs are being developed that interfere with the direct interaction of KEAP1-NRF2 or inhibit BTB domain and CNC homolog 1 (BACH1), which is a transcriptional repressor of the promoter where NRF2 binds.

scholarly journals Political ideology and vaccination willingness: implications for policy design

2021 ◽  
Author(s):  
Marc Debus ◽  
Jale Tosun
Keyword(s):  
Side Effects ◽  
Political Ideology ◽  
Policy Design ◽  
Public Support ◽  
Individual Freedom ◽  
Short Time Period ◽  
Successful Development ◽  
Individual Level ◽  
Time Period ◽  
Short Time

AbstractThe COVID-19 pandemic has forced governments to impose major restrictions on individual freedom in order to stop the spread of the virus. With the successful development of a vaccine, these restrictions are likely to become obsolete—on the condition that people get vaccinated. However, parts of the population have reservations against vaccination. While this is not a recent phenomenon, it might prove a critical one in the context of current attempts to manage the COVID-19 pandemic. Consequently, the task of designing policies suitable for attaining high levels of vaccination deserves enhanced attention. In this study, we use data from the Eurobarometer survey fielded in March 2019. They show that 39% of Europeans consider vaccines to cause the diseases which they should protect against, that 50% believe vaccines have serious side effects, that 32% think that vaccines weaken the immune system, and that 10% do not believe vaccines are tested rigorously before authorization. We find that—even when controlling for important individual-level factors—ideological extremism on both ends of the spectrum explains skepticism of vaccination. We conclude that policymakers must either politicize the issue or form broad alliances among parties and societal groups in order to increase trust in and public support for the vaccines in general and for vaccines against COVID-19 in particular, since the latter were developed in a very short time period and resulted—in particular in case of the AstraZeneca vaccine—in reservations because of the effectiveness and side effects of the new vaccines.

Dyspnea in Aging Rats Due to Disseminated Intravascular Coagulation (DIC)

1989 ◽  
Vol 26 (6) ◽  
pp. 505-509 ◽  
Author(s):  
P. Carthew ◽  
P. Aldred ◽  
R. J. Hill ◽  
J. Riley ◽  
R. E. Edwards
Keyword(s):  
Respiratory Distress ◽  
Respiratory Disease ◽  
Disseminated Intravascular Coagulation ◽  
Thrombus Formation ◽  
Chronic Respiratory Disease ◽  
Fibrinolytic System ◽  
Mycoplasma Pulmonis ◽  
Aging Rats ◽  
Intravascular Coagulation ◽  
Rat Lungs

During an 18-month oncogenicity study using rats, approximately 10% of the animals developed a form of respiratory distress very similar to that seen in the terminal stages of chronic respiratory disease, commonly associated with Mycoplasma pulmonis infection. Investigation of the lungs of the affected rats revealed not only that they did not have the consolidation usually associated with chronic respiratory disease, but they also appeared macroscopically normal. Further investigation of a number of cases revealed systemic intravascular thrombus formation of the type usually referred to as disseminated intravascular coagulation. Using an antiserum to fibrin we have demonstrated the presence of intravascular fibrin deposits in the lungs of the affected rats and have shown them to be the same as experimentally induced intravascular fibrin deposits induced in rat lungs by the administration of thrombin after blocking the fibrinolytic system. This is the first example of such a phenomenon being recorded in aging rats.

scholarly journals Evaluation of medicines advertising in medical journals

2009 ◽  
Vol 45 (2) ◽  
pp. 303-312
Author(s):  
Daliana Maria Berenice de Oliveira Souza ◽  
Suellen Cristiane Medeiros de Lima ◽  
Almária Mariz Batista ◽  
Maria Cleide Ribeiro Dantas de Carvalho
Keyword(s):  
Side Effects ◽  
Adverse Reactions ◽  
Healthcare Professionals ◽  
Scientific Information ◽  
Medical Prescription ◽  
Medical Journals ◽  
Registration Number ◽  
The Common

This work intended to analyze the advertising of medicines requiring medical prescription, divulged into three journals of the neurology and cardiology areas addressed to healthcare professionals. The analysis was based on current legislation, among other criteria, as well as specific literature. The presence of the following items was investigated: registration number, drug name, specific indications, contraindications; cautions and warnings; adverse reactions; possible side effects; posology; legibility of technical-scientific information and bibliographic references, phrases and/or expressions about the medication benefits, as compared to other drugs; safety warnings, healing promises and pictures of people smiling, and the quotations confirmation based on bibliographic references. Among the evaluated legal criteria, it was observed the absence of legibility in technical-scientific information in 85% of advertisements; absence of side effects in 23%; absence of cautions and warnings in 15%; of contraindications in 12.8%; of posology in 6.4%; of registration numbers in 2.7% and of the Common Brazilian Denomination/Common International Denomination (Denominação Comum Brasileira/Denominação Comum Internacional - DCB/DCI) in 0.6%. Out of 130 statements respecting advantages face to others drugs, 23.8% were not confirmed and out of 48 divulged safety messages, 41.7% could not be found in quoted references. The pictures of people smiling was a resource used in 42.2% of advertisements. Out of 1362 references analyzed, 19.7% were not found and 37.1% of quoted affirmations weren't confirmed.

scholarly journals Rheumatological Adverse Events Following Immunotherapy for Cancer

Medicina ◽  
2022 ◽  
Vol 58 (1) ◽  
pp. 94
Author(s):  
Ioana Cretu ◽  
Bogdan Cretu ◽  
Catalin Cirstoiu ◽  
Adrian Cursaru ◽  
Mihaela Milicescu ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Cancer Treatments ◽  
Treatment Conditions ◽  
Clinical Presentations ◽  
Rheumatic Manifestations ◽  
Grade 3 ◽  
Dose Dependent ◽  
Rheumatological Manifestations

Background and Objectives: The occurrence of rheumatological side effects in a patient after receiving immunotherapy for cancer is becoming increasingly common. Oncologists often fail to diagnose and refer affected patients to rheumatologists. This paper presents the various rheumatological adverse events that occur after immunotherapy in patients as well as their treatment and evolution. Materials and Methods: A total of 36 patients were monitored between November 2018 and March 2020. The oncologist monitoring the immunotherapy-treated patients identified the occurrence of musculoskeletal side effects. The grading of toxicities was performed by both the oncologist and the rheumatologist using common terminology criteria for adverse events (CTCAE). Rheumatological treatment was administered, and for some patients, immunotherapy was discontinued. Results: The clinical presentations of the patients varied. Mild side effects (grade 1–2) were reported in a higher proportion than severe side effects (grade 3–5). Therefore, thirty-one patients had mild-to-moderate side effects, and five patients had severe side effects. Adverse reactions occurred, on average, 10 weeks after the initiation of immunotherapy; this indicated that the severity of the toxicity was dose dependent. Patients were treated with NSAIDs or prednisone, depending on the severity of the side effects, and for patients with severe manifestations, immunotherapy was discontinued. The remission of rheumatic manifestations varied depending on the grade of the manifestations. Conclusions: The clinical, biological, and ultrasound presentations of the patients with adverse events followed by cancer treatments differed from classic rheumatological manifestations. Thorough examinations of these patients by both oncologists and rheumatologists are needed in order to correctly diagnose and treat rheumatological adverse events. Multiple studies that include a larger number of participants are needed in order to better understand the pathogenesis and clinical evolution of these patients under different treatment conditions.

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