An overview of the safety assessment of medicines currently used in the COVID-19 disease treatment

Javorac, Dragana; Grahovac, Lazar; Manić, Luka; Stojilković, Nikola; Anđelković, Milena; Bulat, Zorica; Ćosić, Danijela Đukić; Ćurčić, Marijana; Djordjević, Aleksandra Buha

doi:10.1016/j.fct.2020.111639

Cited by 45 publications

(37 citation statements)

References 63 publications

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“…Adverse effects are common with remdesivir, but few studies exist that focus on remdesivir and its effects on the cardiovascular system [1,2,9,10,12,13]. Out of a study of 53 patients receiving remdesivir, 32 patients (60%) experienced adverse events during follow-up [5].…”

Section: Discussionmentioning

confidence: 99%

“…The most common adverse effects of remdesivir are increased hepatic enzymes, diarrhea, anemia, rash, renal impairment, and hypotension [1,2,8,9]. Elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been shown to be reversible after discontinuation of remdesivir per studies [8][9][10]. The purpose of our case reports is to highlight two cases who developed adverse drug reactions (ADRs), both with bradycardia, and one with QTc prolongation with T-wave abnormality during remdesivir treatment, which resolved following early discontinuation of the therapy.…”

Section: Introductionmentioning

confidence: 99%

“…It functions as an adenosine analog that introduces itself into viral RNA, leading to premature chain termination and viral replication inhibition [ 6 , 7 ]. The most common adverse effects of remdesivir are increased hepatic enzymes, diarrhea, anemia, rash, renal impairment, and hypotension [ 1 , 2 , 8 , 9 ]. Elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been shown to be reversible after discontinuation of remdesivir per studies [ 8 - 10 ].…”

Section: Introductionmentioning

confidence: 99%

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Cardiac Adverse Events With Remdesivir in COVID-19 Infection

Gupta¹,

Parker²,

Priyadarshi³

et al. 2020

Cureus

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Since December 2019, coronavirus has gradually progressed to a pandemic with no efficacious treatment. Remdesivir is an antiviral medication and inhibitor of viral RNA dependent RNA polymerase with inhibitory action against SARS-CoV virus. Two patients diagnosed with coronavirus infection with worsening respiratory status were initiated with multimodality therapy with antibiotics, steroids and remdesivir. After initiation of remdesivir, the patients' developed bradycardia, with one of the two also showing signs of worsening QT interval. This reverted upon stopping remdesvir therapy. The prevalence of bradycardia with prolonged QT interval is not well-known yet with this medication.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Cardiac Adverse Events With Remdesivir in COVID-19 Infection

Gupta¹,

Parker²,

Priyadarshi³

et al. 2020

Cureus

View full text Add to dashboard Cite

show abstract

“…Due to the comorbidities in COVID-19 patients, the health status of these individuals is complex. Therefore, the medication’s adverse effects and their combinations in treatment plans should be given special attention [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

The role of androgens in COVID-19

Moradi

Enjezab

Ghadiri‐Anari

2020

Diabetes & Metabolic Syndrome: Clinical Research & Revi

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Background and aim The coronavirus disease 2019 (COVID-19) pandemic is a global health emergency. According to the findings, male patients with COVID-19 infection are at an increased risk for severe complications than females. The causes of this issue are unknown and are most probably multifactorial. Sexual hormones affect the immune system, so estrogen strengthens the immune system, and testosterone suppresses it. Due to the reports of the high prevalence of androgenic alopecia in hospitalized patients with COVID-19 and a higher risk of respiratory disease and increased use of allergy/asthma medications among patients with polycystic ovary syndrome (PCOS) as a hyperandrogenism condition compared with non-PCOS women, this review aimed to evaluate androgens role in COVID-19. Methods 42 related articles from 2008 to 2020 were reviewed with the keywords of androgens, hormonal factors, and hair loss in combination with COVID-19 in medical research databases. Results The evidence of transmembrane protease, serine 2 (TMPRSS2) expression in lung tissue, which is an androgen-regulated gene and expressed mainly in the adult prostate may interpret the increased susceptibility of the male gender to severe COVID-19 complications. Moreover, angiotensin-converting enzyme 2 (ACE-2) acts as a functional receptor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and male hormones are effective in the ACE-2 passageway and simplify SARS-CoV-2 entry into host cells. Conclusion Further studies on the severity of symptoms in patients with COVID-19 in other hyperandrogenism conditions compared to the control group are recommended.

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“…Unfortunately, a latest research has demonstrated that hydroxychloroquine or chloroquine used alone or with a macrolide, do not show a benefit on in-hospital outcomes for COVID-19 and on the contrary, were relevant to decrease in-hospital survival as well as increase frequency of ventricular arrhythmias ( Mehra et al, 2020 ). Therefore, a comprehensive evaluation of the safety profile of potential therapeutic agents against COVID-19 is of paramount importance ( Javorac et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Comprehensive assessment of side effects in COVID-19 drug pipeline from a network perspective

Fan

Hong

et al. 2020

Food and Chemical Toxicology

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Currently, coronavirus disease 2019 (COVID-19), has posed an imminent threat to global public health. Although some current therapeutic agents have showed potential prevention or treatment, a growing number of associated adverse events have occurred on patients with COVID-19 in the course of medical treatment. Therefore, a comprehensive assessment of the safety profile of therapeutic agents against COVID-19 is urgently needed. In this study, we proposed a network-based framework to identify the potential side effects of current COVID-19 drugs in clinical trials. We established the associations between 116 COVID-19 drugs and 30 kinds of human tissues based on network proximity and gene-set enrichment analysis (GSEA) approaches. Additionally, we focused on four types of drug-induced toxicities targeting four tissues, including hepatotoxicity, renal toxicity, lung toxicity, and neurotoxicity, and validated our network-based predictions by preclinical and clinical evidence available. Finally, we further performed pharmacovigilance analysis to validate several drug-tissue toxicities via data mining adverse event reporting data, and we identified several new drug-induced side effects without labeling in Food and Drug Administration (FDA) drug instructions. Overall, this study provides forceful approaches to assess potential side effects on COVID-19 drugs, which will be helpful for their safe use in clinical practice and promoting the discovery of antiviral therapeutics against SARS-CoV-2.

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An overview of the safety assessment of medicines currently used in the COVID-19 disease treatment

Cited by 45 publications

References 63 publications

Cardiac Adverse Events With Remdesivir in COVID-19 Infection

Cardiac Adverse Events With Remdesivir in COVID-19 Infection

The role of androgens in COVID-19

Comprehensive assessment of side effects in COVID-19 drug pipeline from a network perspective

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