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1.
Anticancer Res ; 42(4): 2105-2111, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1766257

ABSTRACT

BACKGROUND/AIM: We investigated whether coronavirus disease 2019 (COVID-19) vaccination and its adverse events would cause cancer treatment of patients with urological cancer to be postponed or changed. PATIENTS AND METHODS: We collected COVID-19 vaccination information including adverse events from the medical records of 214 patients with urological cancer receiving cancer drug therapy. RESULTS: The cancer types were renal cancer in 40 cases (18.7%), upper urinary tract cancer in 10 cases (4.7%), bladder cancer in 21 cases (9.8%), prostate cancer in 140 cases (65.4%), and others in 3 cases (1.4%). Of the 214 patients, 178 (83.2%) had received the second dose of the vaccine. Out of 180 vaccinated patients, some adverse events were observed in 69 (38.3%). Vaccination rates for males and females were 85.4% (169/198) and 68.8% (11/16), respectively, and were not significantly different (p=0.081). The incidence of adverse events was significantly higher in females [72.7% (8/11)] than in males [36.1% (61/169)]; p=0.015. Treatment was modified in 11 vaccinated patients; postponed or changed at the discretion of the attending physician in 8 cases, skipped at the discretion of the patient in 1 case, and postponed due to side effects of the immune checkpoint inhibitor in 1 case. Treatment for one patient with upper urinary tract cancer on pembrolizumab was postponed for three weeks due to adverse events of the vaccine. CONCLUSION: Only 0.6% of the adverse events of the vaccine required postponement of treatment, suggesting that vaccination is safe even during cancer drug therapy.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Urologic Neoplasms , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Male , Urologic Neoplasms/drug therapy , Urologic Neoplasms/etiology , Vaccination/adverse effects
2.
Int J Infect Dis ; 119: 214-216, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1763772

ABSTRACT

Most of the adverse effects reported in patients who have received COVID-19 vaccines have been mild. However, possible serious adverse effects are being monitored cautiously. There have also been a number of case reports of reactivation of varicella zoster infection within 28 days after immunization with mRNA COVID-19 vaccines. A few cases have also been reported after viral vector and inactivated COVID-19 vaccination. The incidence of meningitis following varicella zoster virus infection is rare. In the current study, we report two cases of male patients who received two different types of COVID-19 vaccine (inactivated and viral vector) and developed varicella zoster meningitis within 10 days after vaccination.


Subject(s)
COVID-19 , Chickenpox , Drug-Related Side Effects and Adverse Reactions , Herpes Zoster , Meningitis , COVID-19 Vaccines/adverse effects , Chickenpox/prevention & control , Chickenpox Vaccine/adverse effects , Drug-Related Side Effects and Adverse Reactions/etiology , Herpes Zoster/diagnosis , Herpes Zoster/epidemiology , Herpes Zoster/etiology , Herpesvirus 3, Human , Humans , Male , Meningitis/etiology , Vaccination/adverse effects
3.
Int J Mol Sci ; 23(6)2022 Mar 10.
Article in English | MEDLINE | ID: covidwho-1760646

ABSTRACT

The impressive advances in the knowledge of biomarkers and molecular targets has enabled significant progress in drug therapy for crucial diseases such as cancer. Specific areas of pharmacology have contributed to these therapeutic outcomes-mainly targeted therapy, immunomodulatory therapy, and gene therapy. This review focuses on the pharmacological profiles of these therapeutic classes and intends, on the one hand, to provide a systematic definition and, on the other, to highlight some aspects related to pharmacovigilance, namely the monitoring of safety and the identification of potential toxicities and adverse drug reactions. Although clinicians often consider pharmacovigilance a non-priority area, it highlights the risk/benefit ratio, an essential factor, especially for these advanced therapies, which represent the most innovative and promising horizon in oncology.


Subject(s)
Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Adverse Drug Reaction Reporting Systems , Antineoplastic Agents/adverse effects , Drug-Related Side Effects and Adverse Reactions/drug therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Genetic Therapy , Humans , Medical Oncology , Molecular Targeted Therapy/adverse effects , Pharmacovigilance
4.
Dermatol Ther ; 35(5): e15391, 2022 May.
Article in English | MEDLINE | ID: covidwho-1702166

ABSTRACT

Numerous vaccines are under clinical development and implementation for the prevention of severe course and lethal outcomes of coronavirus disease 2019 (COVID-19). This systematic review aims to summarize and integrated the findings of studies regarding cutaneous side effects of COVID-19 vaccines. This systematic review conducted by searching the scientific databases of PubMed, Scopus, Science direct, and Web of knowledge from the beginning of the COVID-19 to May 10, 2021. Articles were reviewed and analyzed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Seventeen studies on cutaneous side effects of COVID-19 vaccines were included after the screening of search results based on to the eligibility criteria. The results showed that the most common injection site reactions and delayed large local reactions, arising from all vaccine types, were redness/erythema (39%), followed by: itchiness (28%), urticarial rash (17%) on the neck, upper limbs, and trunk, morbilliform eruptions (6.5%), Pityriasis rosea (3%), swelling, and burning, and so forth. Most cutaneous reactions occurred in women (84%), and middle-aged people, after the first dose of vaccine, with the onset ranged from 1 to 21 days after vaccination. In addition, cutaneous reactions were generally self-limiting, and needed little or no therapeutic intervention, that were not regarded as a barrier to injecting a second dose. In conclusion, severe cutaneous side effects are very rare and approved vaccines have satisfactory safety profiles. Therefore, mild or moderate cutaneous reactions should not discourage people from vaccination. In certain groups such as patients with allergies and a history of local injection reactions, pre-vaccination counseling and assurance, also use of appropriate medications may be helpful. However, more studies are needed to investigate the side effect profile of all COVID-19 vaccines.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Middle Aged , Skin , Vaccination/adverse effects
6.
Retina ; 41(12): 2462-2471, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1607338

ABSTRACT

PURPOSE: To describe uveitis cases after the BNT162b2 mRNA SARS-CoV-2 vaccination. METHODS: This is a multicenter, retrospective study. Vaccine-related uveitis diagnosis was supported by the classification of the World Health Organization Adverse Drug Terminology and the Naranjo criteria. RESULTS: Twenty-one patients (23 eyes) with a mean age of 51.3 years (23-78 years) were included. Eight of the 21 patients had a known history of uveitis. The median time from previous to current attack was 1 year (0.5-15 years). There were 21 anterior uveitis cases, two with bilateral inflammation. Eight cases occurred after the first vaccination and 13 after the second vaccination. All but three presented as mild to moderate disease. Two patients developed multiple evanescent white dot syndrome after the second vaccination. The mean time from vaccination to uveitis onset was 7.5 ± 7.3 days (1-30 days). At final follow-up, complete resolution was achieved in all but two eyes, which showed significant improvement. One case of severe anterior uveitis developed vitritis and macular edema after the second vaccination, which completely resolved after an intravitreal dexamethasone injection. CONCLUSION: Uveitis may develop after the administration of the BNT162b2 mRNA vaccine. The most common complication was mild to moderate anterior uveitis, while multiple evanescent white dot syndrome can also occur less frequently.


Subject(s)
/adverse effects , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/etiology , SARS-CoV-2 , Uveitis, Anterior/chemically induced , Vaccination/adverse effects , Adult , Aged , Drug-Related Side Effects and Adverse Reactions/diagnosis , Female , Humans , Male , Middle Aged , Retrospective Studies , Uveitis, Anterior/diagnosis , Young Adult
7.
J Cutan Pathol ; 49(4): 385-387, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1518011

ABSTRACT

Leukocytoclastic vasculitis has been reported in the setting of COVID-19 infection and post-COVID-19 vaccination. We report a case of IgA vasculitis (IgAV) post-COVID-19 vaccination, with immunoglobulin A (IgA) immune deposits in the skin and renal involvement. SARS-CoV spike protein immunohistochemical staining was negative. IgAV with skin and renal involvement is a potential reaction to COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines/adverse effects , /etiology , Aged, 80 and over , Drug-Related Side Effects and Adverse Reactions/complications , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/physiopathology , Humans , Immunohistochemistry/methods , Male
8.
Ocul Immunol Inflamm ; 29(6): 1216-1224, 2021 Aug 18.
Article in English | MEDLINE | ID: covidwho-1437745

ABSTRACT

PURPOSE: The COVID-19 pandemic has galvanized the development of new vaccines at an unprecedented pace. Since the widespread implementation of vaccination campaigns, reports of ocular adverse effects after COVID-19 vaccinations have emerged. This review summarizes ocular adverse effects possibly associated with COVID-19 vaccination, and discusses their clinical characteristics and management. METHODS: Narrative Literature Review. RESULTS: Ocular adverse effects of COVID-19 vaccinations include facial nerve palsy, abducens nerve palsy, acute macular neuroretinopathy, central serous retinopathy, thrombosis, uveitis, multiple evanescent white dot syndrome, Vogt-Koyanagi-Harada disease reactivation, and new-onset Graves' Disease. Studies in current literature are primarily retrospective case series or isolated case reports - these are inherently weak in establishing association or causality. Nevertheless, the described presentations resemble the reported ocular manifestations of the COVID-19 disease itself. Hence, we hypothesize that the human body's immune response to COVID-19 vaccinations may be involved in the pathogenesis of the ocular adverse effects post-COVID-19 vaccination. CONCLUSION: Ophthalmologists and generalists should be aware of the possible, albeit rare, ocular adverse effects after COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/etiology , Eye Diseases/etiology , SARS-CoV-2 , Vaccination/adverse effects , Humans
10.
Expert Rev Hematol ; 14(9): 819-830, 2021 09.
Article in English | MEDLINE | ID: covidwho-1349725

ABSTRACT

INTRODUCTION: Ibrutinib is a highly effective drug for patients with chronic lymphocytic leukemia (CLL), and is well tolerated even by older patients and those unfit to receive conventional immuno-chemotherapy. AREAS COVERED: The occurrence of adverse events was revealed as a major cause of ibrutinib failure in the real-world. Ibrutinib-induced lymphocytosis carries the risk of an untimely interruption of therapy because it may be misinterpreted as disease progression. In addition, drug interactions can worsen ibrutinib-associated toxicities by increasing the plasma concentration of ibrutinib. In this review, we present a case of major hemorrhage and atrial fibrillation (AF) during ibrutinib use and summarize the adverse events associated with ibrutinib. Furthermore, the practical management of ibrutinib-associated toxicities was covered with reference to a drug interaction mechanism. EXPERT OPINION: Clinicians should examine the prescribed drugs prior to ibrutinib initiation and carefully monitor toxicities while taking ibrutinib. A reduced dose of ibrutinib with the concurrent use of CYP3A inhibitors such as antifungal agents could be an attractive strategy to reduce toxicities and may confer financial benefits. Reducing unexpected toxicities is as significant as achieving treatment response in the era of life-long therapy with ibrutinib in patients with CLL.


Subject(s)
Adenine/analogs & derivatives , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Piperidines/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Adenine/adverse effects , Adenine/pharmacology , Adenine/therapeutic use , Aged , COVID-19/complications , Disease Management , Drug Interactions , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/therapy , Humans , Leukemia, Lymphocytic, Chronic, B-Cell/complications , Male , Piperidines/adverse effects , Piperidines/pharmacology , Protein Kinase Inhibitors/adverse effects , Protein Kinase Inhibitors/pharmacology
11.
Elife ; 102021 08 03.
Article in English | MEDLINE | ID: covidwho-1339710

ABSTRACT

The discovery of a drug requires over a decade of intensive research and financial investments - and still has a high risk of failure. To reduce this burden, we developed the NICEdrug.ch resource, which incorporates 250,000 bioactive molecules, and studied their enzymatic metabolic targets, fate, and toxicity. NICEdrug.ch includes a unique fingerprint that identifies reactive similarities between drug-drug and drug-metabolite pairs. We validated the application, scope, and performance of NICEdrug.ch over similar methods in the field on golden standard datasets describing drugs and metabolites sharing reactivity, drug toxicities, and drug targets. We use NICEdrug.ch to evaluate inhibition and toxicity by the anticancer drug 5-fluorouracil, and suggest avenues to alleviate its side effects. We propose shikimate 3-phosphate for targeting liver-stage malaria with minimal impact on the human host cell. Finally, NICEdrug.ch suggests over 1300 candidate drugs and food molecules to target COVID-19 and explains their inhibitory mechanism for further experimental screening. The NICEdrug.ch database is accessible online to systematically identify the reactivity of small molecules and druggable enzymes with practical applications in lead discovery and drug repurposing.


Subject(s)
Drug Design , Drug Discovery/methods , Drug Repositioning , Pharmaceutical Preparations/metabolism , Animals , Antimetabolites, Antineoplastic/chemistry , Antimetabolites, Antineoplastic/metabolism , Antiviral Agents/chemistry , Antiviral Agents/pharmacology , COVID-19/drug therapy , Databases, Pharmaceutical , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/metabolism , Fluorouracil/chemistry , Fluorouracil/metabolism , Humans , Pharmaceutical Preparations/chemistry , Workflow
12.
Expert Opin Drug Saf ; 20(12): 1559-1564, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1334105

ABSTRACT

Background: Remdesivir has been used for treating patients with moderate to severe coronavirus disease 2019 (COVID-19) although there is conflicting evidence regarding its usefulness. Data regarding its safety largely come from the clinical trials conducted to support its emergency use authorization (EUA). This study aimed to identify the adverse events of remdesivir with disproportionately high reporting using real-world data.Research design and methods: The adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) by health-care professionals for drugs that have received EUA or approved for the treatment of COVID-19 in the US were studied. Adisproportionality analysis was performed to determine adverse events more frequently reported with remdesivir compared with other COVID-19 drugs in the database.Results: Elevated liver enzymes, acute kidney injury, raised blood creatinine levels, bradycardia, cardiac arrest, and death had disproportionately higher reporting with remdesivir as asuspect drug compared with other drugs. There is no significant difference in the reporting of these events based on patient sex or age.Conclusions: Our study confirms the drug label information regarding liver enzyme elevation. The renal and cardiac safety signals identified necessitate reevaluation for potential drug-labeling changes.


Subject(s)
Acute Kidney Injury , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Bradycardia , COVID-19 , Drug-Related Side Effects and Adverse Reactions , Liver Function Tests , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Adenosine Monophosphate/administration & dosage , Adenosine Monophosphate/adverse effects , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Alanine/administration & dosage , Alanine/adverse effects , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Bradycardia/chemically induced , Bradycardia/diagnosis , COVID-19/complications , COVID-19/drug therapy , COVID-19/epidemiology , Drug Approval/methods , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Liver Function Tests/methods , Liver Function Tests/statistics & numerical data , Male , Middle Aged , SARS-CoV-2 , United States/epidemiology , United States Food and Drug Administration/statistics & numerical data
13.
BMJ ; 374: n1647, 2021 07 21.
Article in English | MEDLINE | ID: covidwho-1320441

ABSTRACT

OBJECTIVE: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations. DESIGN: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. SETTING: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. PARTICIPANTS: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years. INTERVENTION: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. MAIN OUTCOME MEASURES: The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ). RESULTS: For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group. CONCLUSIONS: Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic. TRIAL REGISTRATION: Clinicaltrials.gov NCT02356081.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Cell Phone , Drug-Related Side Effects and Adverse Reactions/diagnosis , Quality of Life , Telemedicine/methods , Adult , Aged , Austria , Breast Neoplasms/psychology , Breast Neoplasms/therapy , Chemotherapy, Adjuvant/adverse effects , Colorectal Neoplasms/psychology , Colorectal Neoplasms/therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/psychology , Female , Greece , Hodgkin Disease/psychology , Hodgkin Disease/therapy , Humans , Ireland , Lymphoma, Non-Hodgkin/psychology , Lymphoma, Non-Hodgkin/therapy , Male , Middle Aged , Norway , Telemedicine/instrumentation , Treatment Outcome , United Kingdom
14.
J Cutan Pathol ; 49(1): 34-41, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1320386

ABSTRACT

BACKGROUND: As more people become vaccinated against the SARS-CoV-2 virus, reports of delayed cutaneous hypersensitivity reactions are beginning to emerge. METHODS: In this IRB-approved retrospective case series, biopsy specimens of potential cutaneous adverse reactions from the Pfizer-BioNTech or Moderna mRNA vaccine were identified and reviewed. Clinical information was obtained through the requisition form, referring clinician, or medical chart review. RESULTS: Twelve cases were included. Histopathological features from two injection-site reactions showed a mixed-cell infiltrate with eosinophils and a spongiotic dermatitis with eosinophils. Three biopsy specimens came from generalized eruptions that showed interface changes consistent with an exanthematous drug reaction. Three biopsy specimens revealed a predominantly spongiotic pattern, consistent with eczematous dermatitis. Small-vessel vascular injury was seen in two specimens, which were diagnosed as urticarial vasculitis and leukocytoclastic vasculitis, respectively. There were two cases of new-onset bullous pemphigoid supported by histopathological examination and direct immunofluorescence studies. Eosinophils were seen in 10 cases. CONCLUSIONS: Dermatopathologists should be aware of potential cutaneous adverse reactions to mRNA-based COVID-19 vaccines. Histopathological patterns include mixed-cell infiltrates, epidermal spongiosis, and interface changes. Eosinophils are a common finding but are not always present. Direct immunofluorescence studies may be helpful for immune-mediated cutaneous presentations such as vasculitis or bullous pemphigoid.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/pathology , Hypersensitivity, Delayed/pathology , /adverse effects , Adult , Aged , Aged, 80 and over , Biopsy/methods , COVID-19/diagnosis , COVID-19/immunology , COVID-19/virology , Dermatitis/etiology , Dermatitis/pathology , Drug-Related Side Effects and Adverse Reactions/etiology , Eosinophils/pathology , Female , Fluorescent Antibody Technique, Direct/methods , Humans , Hypersensitivity, Delayed/etiology , Male , Middle Aged , Pemphigoid, Bullous/diagnosis , Pemphigoid, Bullous/pathology , Retrospective Studies , SARS-CoV-2/genetics , SARS-CoV-2/immunology , Skin/pathology , Vasculitis/chemically induced , Vasculitis/pathology
15.
S Afr Fam Pract (2004) ; 63(1): e1-e3, 2021 06 28.
Article in English | MEDLINE | ID: covidwho-1296012

ABSTRACT

The use of hand sanitisers is common practice to prevent the spread of coronavirus disease 2019 (COVID-19). However, the safety thereof requires consideration as this may be hazardous in children. Recent studies have shown that the misuse and increased unsupervised availability of alcohol-based hand sanitisers may result in adverse events in children such as skin irritation, dryness, cracking and peeling. Unintentional or intentional ingestion of hand sanitisers in children under the age of 12 years may occur because of the colour, smell and flavour added to it. Consumption of alcohol in children may result in hypoglycaemia, apnoea and acidosis. This allows the invasion of other bacterial and viral infections. Children may also rub their eyes with sanitised hands and cause ocular injury. Therefore, the use of hand sanitisers in general needs to be revised in both children and adults. Other interventions on lowering the risk of adverse events because of misuse of hand sanitiser should be practised more often. These include promoting washing of hands over sanitisers where possible, training children on how to use hand sanitisers and creating awareness of the dangers if ingested or in contact with the eyes.


Subject(s)
COVID-19 , Disease Transmission, Infectious/prevention & control , Drug-Related Side Effects and Adverse Reactions , Hand Sanitizers , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/transmission , Child , Child Health , Communicable Disease Control/methods , Drug Misuse/adverse effects , Drug Misuse/prevention & control , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Eye Diseases/chemically induced , Eye Diseases/prevention & control , Hand Disinfection/methods , Hand Sanitizers/pharmacology , Hand Sanitizers/toxicity , Humans , Risk Adjustment/methods , SARS-CoV-2/drug effects , Skin Diseases/chemically induced , Skin Diseases/prevention & control
17.
Int J Clin Pharm ; 43(4): 1133-1138, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1252181

ABSTRACT

The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.


Subject(s)
Adverse Drug Reaction Reporting Systems , Antiviral Agents/adverse effects , COVID-19/drug therapy , Pharmacovigilance , Adverse Drug Reaction Reporting Systems/organization & administration , Antiviral Agents/therapeutic use , COVID-19/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Humans , Patient Safety , SARS-CoV-2/drug effects
19.
Int J Psychiatry Clin Pract ; 25(2): 142-146, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1221414

ABSTRACT

OBJECTIVE: Psychiatric patients are at increased risk of contamination, morbidity, and mortality associated with COVID-19, together with potentially more pronounced adverse effects. We present and discuss the adverse effects observed in an acute psychiatric clinic that has admitted COVID-19 patients during the first three months of the pandemic in Turkey. METHODS: The COVID-19 treatment schemes were formed in accordance with the national and regional guidelines at the time of admittance, which were mainly based on the use of hydroxychloroquine and other drugs. The sample consisted exclusively of inpatients, and all patients were enrolled in the study regardless of their specific diagnosis or treatment schemes. RESULTS: 4 out of 23 patients (17.4%) had experienced adverse effects, two of which had mild hepatic enzyme elevation and one had mild sinus bradycardia. Of note is that we haven't encountered any serious complications or life-threatening events during inpatient treatment. The most emphasised adverse effect in the literature, namely QTc prolongation and ECG changes, were not observed in our sample. The adverse effects were not found to be significantly associated with patient-related factors nor dose of antipsychotic medication. CONCLUSIONS: From our point of view, non-cardiac adverse effects should not be overlooked while treating comorbid psychiatric and COVID-19 patients.KEY POINTSAcute inpatient psychiatric treatment of patients who have comorbid COVID-19 is a complex situation requiring multidisciplinary action.Adverse drug reactions, which may or not result from the interaction of psychiatric and COVID-19 treatment, should be of concern for this patient group.While there is controversy over the benefits of some of the off-label COVID-19 medications, there should also be discussion over safety and concomitant medication use.In order to be adequately prepared for future escalations of COVID-19 pandemic, psychiatric services should thoroughly evaluate their initial experience with COVID-19, including from the point of drug effectiveness and safety.


Subject(s)
Antiviral Agents/adverse effects , COVID-19/drug therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Mental Disorders/drug therapy , Psychotropic Drugs/adverse effects , Adult , Antiviral Agents/administration & dosage , Antiviral Agents/therapeutic use , COVID-19/complications , Drug Interactions , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Hospitals, Psychiatric/statistics & numerical data , Humans , Male , Mental Disorders/complications , Middle Aged , Psychotropic Drugs/administration & dosage , Psychotropic Drugs/therapeutic use
20.
Clin Pharmacol Ther ; 110(1): 108-122, 2021 07.
Article in English | MEDLINE | ID: covidwho-1212738

ABSTRACT

Numerous drugs are currently under accelerated clinical investigation for the treatment of coronavirus disease 2019 (COVID-19); however, well-established safety and efficacy data for these drugs are limited. The goal of this study was to predict the potential of 25 small molecule drugs in clinical trials for COVID-19 to cause clinically relevant drug-drug interactions (DDIs), which could lead to potential adverse drug reactions (ADRs) with the use of concomitant medications. We focused on 11 transporters, which are targets for DDIs. In vitro potency studies in membrane vesicles or HEK293 cells expressing the transporters coupled with DDI risk assessment methods revealed that 20 of the 25 drugs met the criteria from regulatory authorities to trigger consideration of a DDI clinical trial. Analyses of real-world data from electronic health records, including a database representing nearly 120,000 patients with COVID-19, were consistent with several of the drugs causing transporter-mediated DDIs (e.g., sildenafil, chloroquine, and hydroxychloroquine). This study suggests that patients with COVID-19, who are often older and on various concomitant medications, should be carefully monitored for ADRs. Future clinical studies are needed to determine whether the drugs that are predicted to inhibit transporters at clinically relevant concentrations, actually result in DDIs.


Subject(s)
Antiviral Agents , COVID-19 , Drug Interactions , Drug-Related Side Effects and Adverse Reactions , Membrane Transport Proteins/metabolism , Virus Internalization/drug effects , Virus Replication/drug effects , Antiviral Agents/pharmacokinetics , COVID-19/drug therapy , COVID-19/virology , Clinical Trials as Topic , Drug Monitoring/methods , Drug Monitoring/standards , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/metabolism , Drug-Related Side Effects and Adverse Reactions/prevention & control , Electronic Health Records/statistics & numerical data , HEK293 Cells , Humans , Hydroxychloroquine/pharmacokinetics , Risk Assessment/methods , SARS-CoV-2/drug effects , SARS-CoV-2/physiology
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