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Expert Opinion on Drug Safety 2023Enzalutamide, a second-generation anti-androgen drug, is an androgen receptor inhibitor developed to overcome resistance to first-generation anti-androgens, such as...
OBJECTIVES
Enzalutamide, a second-generation anti-androgen drug, is an androgen receptor inhibitor developed to overcome resistance to first-generation anti-androgens, such as bicalutamide. This study aimed to identify previously undisclosed adverse events associated with enzalutamide.
METHODS
Adverse reactions following enzalutamide administration were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, and the data obtained were from 2014 to 2023. Four algorithms, namely ROR, PRR, BCPNN, and EBGM, were used to detect signs of adverse reactions associated with enzalutamide use.
RESULTS
This study determined several adverse reactions in the nervous system, including hypogeusia, ageusia, dysgeusia, normal-pressure hydrocephalus, dementia, amnesia, balance disorders, and seizure-like phenomena. The mental aspects manifested as laziness, confusion, and eating disorders. Gastrointestinal system-related adverse reactions included dysphagia, constipation, fecal hardening, and abdominal discomfort. We identified several previously unreported adverse reactions, including normal-pressure hydrocephalus, dementia, balance disorders, eating disorders, and dysphagia.
CONCLUSION
Our study revealed novel adverse events associated with enzalutamide, particularly in the nervous system, that have not been previously documented. These findings have important implications for future clinical medication guidelines.
Topics: United States; Humans; United States Food and Drug Administration; Deglutition Disorders; Adverse Drug Reaction Reporting Systems; Hydrocephalus; Dementia
PubMed: 37670490
DOI: 10.1080/14740338.2023.2255524 -
Wiadomosci Lekarskie (Warsaw, Poland :... 2024Aim: To review the publications subject to the problem of COVID-19 associated anosmia incidence in pediatric patients as well as its pathogenesis, diagnostics, treatment... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Aim: To review the publications subject to the problem of COVID-19 associated anosmia incidence in pediatric patients as well as its pathogenesis, diagnostics, treatment and recovery. The peculiarity of pediatric COVID-19 anosmia is due to children accounting for very low percentage of COVID-19 patients (comparing to one in adults), mostly with milder course of the disease. Awareness of anosmia and its proper diagnostics is crucial in children and adolescents, considering it can be the only manifestation in COVID-19 positive pediatric patients.
PATIENTS AND METHODS
Materials and Methods: In order to achieve this goal a meta-analysis of information from databases followed by statistical processing and generalisation of the obtained data was carried out.
CONCLUSION
Conclusions: Publications on COVID-19 anosmia in children and adolescents are less numerous than those concerning adult patients, so it is important to use every single trustworthy one. Anosmia/ageusia may be the only symptom, early identifier and the strongest predictor of COVID-19 infection in pediatric patients. Prospects for further scientific researches. Further researches regarding differential diagnostics of COVID-19 and other infections, including seasonal influenza, manifesting with both olfactory and taste dysfunction as well as anosmia diagnostics in children and adolescents with autistic spectrum and different types of mental disorders are possible.
Topics: Adolescent; Adult; Child; Humans; Ageusia; Anosmia; COVID-19; Olfaction Disorders; SARS-CoV-2
PubMed: 38431815
DOI: 10.36740/WLek202401114 -
Zhonghua Er Bi Yan Hou Tou Jing Wai Ke... Aug 2023
Topics: Humans; COVID-19; Ageusia
PubMed: 37599248
DOI: 10.3760/cma.j.cn115330-20230106-00008 -
Frontiers in Endocrinology 2024Patients with primary adrenal insufficiency due to congenital adrenal hyperplasia (CAH) are at risk for adrenal crisis during infectious illnesses. Increased risk of...
CONTEXT
Patients with primary adrenal insufficiency due to congenital adrenal hyperplasia (CAH) are at risk for adrenal crisis during infectious illnesses. Increased risk of infection including COVID-19 has been variably reported.
OBJECTIVE
To evaluate COVID-19 illness outcomes and stress dose practices in a large cohort of patients with CAH during the first two years of the pandemic and compare observations of COVID-19 infection in patients with CAH to the general USA population.
METHODS
Between March 2020 and November 2022, patients with CAH followed at the National Institutes of Health Clinical Center were queried about COVID-19 infection during their routine visits. Cases of COVID-19 were compared to controls. COVID-19 infection rates and symptoms were compared to general USA population data from the Centers for Disease Control and Prevention.
RESULTS
Of 168 patient visits, there were 54 (32%) cases of COVID-19 infection, and 15 (28%) were pediatric. Overall an association was found between acquiring COVID-19 and obesity (p=0.018), and adults acquiring COVID-19 were on lower doses of fludrocortisone (p=0.008). Fewer cases of COVID-19 infection were reported in those receiving hydrocortisone or modified-release hydrocortisone compared to longer acting glucocorticoids (p=0.0018). In our CAH population, the pattern of COVID-19 infection rates and COVID-related symptomatology were similar to those observed in the general USA population. Most patients with the presumed alpha variant reported anosmia and ageusia, while gastrointestinal symptoms were commonly reported during the delta and omicron waves. Stress dosing occurred in 30/54 cases, and 7 received parenteral hydrocortisone. Two hospitalizations occurred; one pediatric and one adult, both with co-morbidities. There were 5 emergency room visits and no reported deaths.
CONCLUSION
Patients with CAH with close follow-up do not appear to be at increased risk of acquiring COVID-19 or to have a more severe course of COVID-19 compared to the general USA population. Obesity may increase risk of acquiring COVID-19 in patients with CAH, and overall infection risk may be lower in those receiving short-acting and circadian glucocorticoid replacement therapy. Established age-appropriate guidelines for stress dosing during infectious illnesses should be used for patients with CAH and COVID-19. COVID-19 specific guidelines are not indicated. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT00250159.
Topics: Adult; Child; Humans; Adrenal Hyperplasia, Congenital; COVID-19; Glucocorticoids; Hydrocortisone; Obesity; SARS-CoV-2; United States; Case-Control Studies
PubMed: 38405151
DOI: 10.3389/fendo.2024.1348130 -
Journal of Neurovirology Aug 2023The occurrence of neurological manifestations and complications in pregnant women compared to non-pregnant women with COVID-19 is unclear. This cross-sectional study...
The occurrence of neurological manifestations and complications in pregnant women compared to non-pregnant women with COVID-19 is unclear. This cross-sectional study included women aged over 18 years hospitalized with SARS-CoV-2 infection confirmed by RT-PCR from March to June 2020 in Recife, Brazil. We evaluated 360 women, including 82 pregnant patients who were significantly younger (27.5 vs. 53.6 years; p < 0.01) and less frequently obese (2.4% vs. 15.1%; p < 0.01) than the non-pregnant group. All pregnancies were confirmed using ultrasound imaging. Abdominal pain was the only more frequent COVID-19 manifestation during pregnancy (23.2% vs. 6.8%; p < 0.01), but was not associated with the outcomes. Almost half the pregnant women presented neurological manifestations, including anosmia (31.7%), headache (25.6%), ageusia (17.1%), and fatigue (12.2%). However, neurological manifestations occurred similarly in pregnant and non-pregnant women. Four (4.9%) pregnant women and 64 non-pregnant women (23%) presented delirium, but the frequency with age-adjustment was similar in the non-pregnant group. Pregnant women with COVID and preeclampsia (19.5%) or eclampsia (3.7%) were older (31.8 vs. 26.5 years; p < 0.01), and epileptic seizures occurred more often in association with eclampsia (18.8% vs. 1.5%; p < 0.01) regardless of previous epilepsy. There were three maternal deaths (3.7%), one dead fetus, and one miscarriage. The overall prognosis was good. There was no difference in prolonged hospital stay, the need for ICU and mechanical ventilation, or death when comparing pregnant and non-pregnant women.
Topics: Pregnancy; Humans; Female; Adult; Middle Aged; COVID-19; Cross-Sectional Studies; SARS-CoV-2; Eclampsia; Pregnancy Complications, Infectious
PubMed: 37306922
DOI: 10.1007/s13365-023-01150-2 -
The International Journal of... Jul 2023The current pandemic caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is accompanied with a rapid increase of reports and papers detailing its... (Meta-Analysis)
Meta-Analysis
The current pandemic caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is accompanied with a rapid increase of reports and papers detailing its neurological effects and symptoms. The virus infection causes respiratory illness named by the world health organization as corona virus 19 (COVID-19).This systematic review aims to study and summarize the different neurological manifestations of this virus. All articles published and indexed via Pubmed, Medline and Google Scholar databases between January 1st 2020 and February 28th 2021 that reported neurological symptoms of SARS-CoV-2 are reviewed following the Preferred Reporting Items for Systemic review and Meta-Analysis (PRISMA) guidelines.We included data from 113 articles: eight prospective studies, 25 retrospective studies and the rest were case reports/series. COVID-19 can present with central nervous system manifestations, such as headache, encephalitis and encephalopathy, peripheral nervous system manifestations, such as anosmia, ageusia and Guillian Barre syndrome, and skeletal muscle manifestations, such as myalgia and myasthenia gravis. Our systematic review showed that COVID-19 can be manifested by a wide spectrum of neurological symptoms reported either in the early stage or within the course of the disease. However, a detailed comprehension of these manifestations is required and more studies are needed in order to improve our scientific knowledge and to develop preventive and therapeutic measures to control this pandemic.
Topics: Humans; COVID-19; SARS-CoV-2; Nervous System Diseases; Comprehension; Prospective Studies; Retrospective Studies
PubMed: 34433369
DOI: 10.1080/00207454.2021.1973000 -
Pediatric Neurology Aug 2023We aimed to analyze pediatric patients with coronavirus disease 2019 (COVID-19) with a diverse spectrum of neurological manifestations in a single center since...
BACKGROUND
We aimed to analyze pediatric patients with coronavirus disease 2019 (COVID-19) with a diverse spectrum of neurological manifestations in a single center since neurological involvement in children is still poorly understood.
METHODS
We performed a retrospective study on 912 children aged between zero and 18 years who had a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result and symptoms of COVID-19 from March 2020 to March 2021 in a single center.
RESULTS
Among 912 patients, 37.5% (n = 342) had neurological symptoms and 62.5% (n = 570) had no neurological symptoms. The mean age of patients with neurological symptoms was significantly higher (14.2 ± 3.7 vs 9.9 ± 5.7; P < 0.001). Three hundred and twenty-two patients had nonspecific symptoms (ageusia, anosmia, parosmia, headache, vertigo, myalgia), whereas 20 patients had specific involvement (seizures/febrile infection-related epilepsy syndrome, cranial nerve palsy, Guillain-Barré syndrome and variants, acute disseminated encephalomyelitis, central nervous system vasculitis). The mean age of the patients with nonspecific neurological symptoms was significantly higher (14.6 ± 3.1 vs 7.7 ± 5.7; P < 0.001).
CONCLUSION
This study presents a large number of patients with a diverse spectrum of neurological manifestations. The rare neurological manifestations reported in our study will contribute to better understanding the neurological involvement of SARS-CoV-2 in children. The study also points out the differences of SARS-CoV-2-related neurological manifestations between patients at different ages. Physicians should be alert about recognizing the early neurological manifestations of the SARS-CoV-2 in children.
Topics: Humans; Child; Infant, Newborn; Infant; Child, Preschool; Adolescent; COVID-19; SARS-CoV-2; Retrospective Studies; Headache; Seizures; Nervous System Diseases
PubMed: 37369146
DOI: 10.1016/j.pediatrneurol.2023.05.018 -
Auris, Nasus, Larynx Aug 2023With the COVID-19 pandemic, there is growing interest and research in olfactory and gustatory dysfunction (OGD). Drug-induced dysfunction is an often overlooked...
OBJECTIVES
With the COVID-19 pandemic, there is growing interest and research in olfactory and gustatory dysfunction (OGD). Drug-induced dysfunction is an often overlooked etiology. While several medications include smell or taste disturbance as a side effect, there are no publications describing which medications are most frequently implicated. We aim to describe the patterns of these adverse drug reactions (ADRs) using the FDA Adverse Events Reporting System (FAERS).
METHODS
The FAERS database was queried from 2011 to 2021 for terms describing ADRs related to OGD. Terms included anosmia, hyposmia, olfactory test abnormal, olfactory nerve disorder, hallucination olfactory, parosmia, ageusia, hypogeusia, dysgeusia, and taste disorder. We identified the top reported medications associated with general smell dysfunction, general taste dysfunction, reduced smell, and altered smell.
RESULTS
From 2011 to 2021, 16,091 ADRs were reported with OGD, of which13,641 (84.8%) and 2,450 (15.2%) were associated with gustatory and olfactory reactions, respectively. Zinc products (370 reports) and fluticasone propionate (214) were most commonly associated with olfactory dysfunction, specifically reduced olfaction. Varenicline (24) and fluticasone propionate (23) were most commonly associated with altered smell. Lenalidomide (490) and sunitinib (468) were most commonly associated with gustatory dysfunction. Antineoplastic and immunomodulating medications accounted for 21.6% and 36.3% of olfactory and gustatory ADRs, respectively. Among this category, immunoglobulin drugs were the most commonly associated with OGD ADRs.
CONCLUSION
Gustatory dysfunction is more commonly reported ADR compared with olfactory dysfunction. Immunologic/rheumatologic medications are the leading culprit of reported OGD. With increasing numbers of patients presenting to otolaryngologists for OGD, it is important to consider drug-induced etiology.
LEVEL OF EVIDENCE
III.
Topics: Humans; Smell; COVID-19; Pandemics; SARS-CoV-2; Taste Disorders; Ageusia; Dysgeusia; Olfaction Disorders; Anosmia
PubMed: 36682949
DOI: 10.1016/j.anl.2022.12.012 -
European Journal of Public Health Dec 2023To improve research and care for patients with post-COVID-19 condition more insight into different subtypes of post-COVID-19 condition and their risk factors is urgently...
BACKGROUND
To improve research and care for patients with post-COVID-19 condition more insight into different subtypes of post-COVID-19 condition and their risk factors is urgently needed. We aimed to identify risk factors of post-COVID-19 condition in general and for specific symptom profiles.
METHODS
This study is based on data collected within the Lifelines Coronavirus disease 2019 (COVID-19) cohort (N = 76 503). Mean pre- and post-SARS-CoV-2 infection symptom scores were compared to classify post-COVID-19 condition. Latent Profile Analysis was used to identify symptom profiles. Logistic and multinomial regression analyses were used to examine the association between demographic, lifestyle and health-related risk factors and post-COVID-19 condition, and symptom profiles, respectively.
RESULTS
Of the 3465 participants having had COVID-19, 18.5% (n = 642) classified for post-COVID-19 condition. Four symptom profiles were identified: muscle pain, fatigue, cardiorespiratory and ageusia/anosmia. Female sex was a risk factor for the muscle pain and fatigue profiles. Being overweight or obese increased risk for all profiles, except the fatigue profile. Having a chronic disease increased the risk for all profiles except the ageusia/anosmia profile, with the cardiorespiratory profile being only significant in case of multimorbidity. Being unvaccinated increased risk of the ageusia/anosmia profile.
CONCLUSIONS
Findings from this study suggest that Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may trigger different pathophysiological mechanisms that may result in different subtypes of post-COVID-19 condition. These subtypes have shared and unique risk factors. Further characterization of symptom profiles and quantification of the individual and societal impact of specific symptom profiles are pressing challenges for future research.
Topics: Humans; Female; Longitudinal Studies; Ageusia; Anosmia; Myalgia; COVID-19; SARS-CoV-2; Cohort Studies; Risk Factors; Fatigue
PubMed: 37608757
DOI: 10.1093/eurpub/ckad152 -
L'Encephale Dec 2023Stigma was a major issue during the COVID-19 pandemic. It posed a serious threat to the lives of healthcare workers (HCWs) who were expected to experience higher levels...
BACKGROUND AND OBJECTIVES
Stigma was a major issue during the COVID-19 pandemic. It posed a serious threat to the lives of healthcare workers (HCWs) who were expected to experience higher levels of stigma and increased psychological distress. This is the first survey to investigate forms and correlates of perceived stigma in Tunisian HCWs during the COVID-19 pandemic.
METHODS
A cross-sectional web-based survey was conducted between October 8th and November 10th 2020, among 250 Tunisian HCWs. Data were collected using an online questionnaire using the Google Forms® platform. We used a self-reported instrument measuring COVID-19-related stigma, and the Multidimensional Scale of Perceived Social Support (MSPSS) to measure the perceived adequacy of social support from three sources: family, friends, and significant other.
RESULTS
The mean stigma score was 18.6±8. Participants sometimes to often experienced stigma in their relationships with friends (22%), neighbors (27.2%), parents (22,4%), and in social activities (30.8%). This stigma was perceived mainly through avoidance (68.4%), and rarely through verbal (6%) or physical aggression (1.2%). The mean MSPSS total score was 5.26±1.24. In multivariate analysis, depression history (P<0.001), long working experience (P<0.001), having presented ageusia/anosmia (P=0.007) and lower total social support scale (P<0.001) were significantly associated with higher perceived stigma score.
CONCLUSION
Our findings showed that HCWs perceived stigma in professional, societal and familial domains. Social support from family, friends and others seemed to protect against perceived stigma. Proper health education targeting the public appears to be an effective method to prevent social harassment of both HCWs and COVID-19 survivors.
Topics: Humans; COVID-19; Cross-Sectional Studies; Pandemics; Social Stigma; Health Personnel
PubMed: 36411122
DOI: 10.1016/j.encep.2022.08.014