The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration’s Adverse Event Reporting System

Alsuhaibani, Deemah S.; Edrees, Heba; Alshammari, Thamir M

doi:10.1016/j.jsps.2023.05.023

Cited by 3 publications

(2 citation statements)

References 28 publications

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“…Favipiravir has shown side effects such as QTC prolongation, hyperuricemia, abnormalities in liver enzymes, elevation of uric acid, total bilirubin, and liver enzymes, along with gastrointestinal disorders in clinical trials. Conversely, no adverse events were reported in the azvudine group in a clinical trial (Ren et al, 2020;Shan et al, 2020;Wu et al, 2022;Alsuhaibani et al, 2023;Batool et al, 2023). In addition,…”

Section: Figurementioning

confidence: 92%

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system

Liang,

Ma,

Wang

et al. 2023

Front. Pharmacol.

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Molnupiravir, an urgently approved drug during the Coronavirus Disease 2019 (COVID-19) pandemic, serves as the basis for our study, which relies on the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective is to extract adverse event (AE) signals associated with molnupiravir from the FAERS database, thereby providing a reference for post-marketing monitoring of adverse events. Specifically, we extracted individual case safety reports (ICSRs) from the database, focusing on cases with COVID-19 indications and molnupiravir identified as the primary suspect drug. Descriptive analysis of the extracted data was performed, followed by four disproportionality analyses using the reporting odds ratio (ROR) method. These analyses were conducted across four levels, encompassing overall data, reports by health professionals, as well as age and gender differentiations, ensuring the robustness of the analysis results. In total, 116,576 ICSRs with COVID-19 indications and 2,285 ICSRs with molnupiravir as the primary suspect were extracted. Notably, after excluding cases with unknown age or gender, a higher proportion of molnupiravir-related ICSRs were observed among individuals aged 65 years and older (70.07%) and women (54.06%). The most frequently reported adverse events and AE signals were associated with gastrointestinal disorders, as well as skin and subcutaneous tissue disorders. Moreover, individuals aged 65 years and older exhibited a higher risk of cardiac disorders, hepatobiliary disorders, renal and urinary disorders, and vascular disorders. In conclusion, this study found molnupiravir demonstrated a lower risk of serious adverse events compared to other RNA antiviral drugs like remdesivir in patients under 65 years old. However, close monitoring of its safety is still necessary for elderly patients aged 65 years and above. Further studies are warranted to continuously assess the safety profile of molnupiravir as its usage increases, especially in high risk populations.

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Section: Figurementioning

confidence: 92%

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system

Liang,

Ma,

Wang

et al. 2023

Front. Pharmacol.

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“…The four four components (cells) of the 2 × 2 tables were labeled “a,” “b,” “c,” and “d,” where “a” represents the number of reports of cases (outcome of interest) for the studied drugs, and “b” is the number of reports of non-cases (no outcome of interest, adverse events) for those drugs. Furthermore, “c” represents the number of reported cases for other medications, and “d” represents the number of reports of non-cases for all other medications ( Alsuhaibani, et al, 2023 ). Poluzzi et al (2012) provides an explanation of the mathematical equations.…”

Section: Methodsmentioning

confidence: 99%

Pancreatitis with use of new diabetic medications: a real-world data study using the post-marketing FDA adverse event reporting system (FAERS) database

Alenzi,

Alsuhaibani,

Batarfi

et al. 2024

Front. Pharmacol.

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Background: Pancreatitis is characterized by inflammation of the pancreas and significantly affects quality of life. Less than 5% of pancreatitis cases are drug-induced, but recent evidence suggests a substantial risk associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The aim of this study was to compare the risk of developing pancreatitis between those using GLP-1 RAs and those using sodium-glucose transport protein 2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors.Methods: This study was done using the FDA Adverse Event Reporting System (FAERS) database from 2019 to 2021. This database contains information from diverse submissions from healthcare providers, patients, and manufacturers. To ensure fairness and accuracy, the risk of pancreatitis associated with other hypoglycemic agents (SGLT2 inhibitors and DPP-4 inhibitors) was also investigated. Traditional and Bayesian statistical analysis methods were used to identify disproportionate statistics and included the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). A drug–adverse-event combination that met the criteria of all four indices was deemed a signal.Results: The analysis of 2,313 pancreatitis reports linked to hypoglycemic agents revealed a predominant association with GLP-1 RA (70.2%) compared to DPP-4 inhibitors (15%) and SGLT2 (14.7%). Most of these reports involved female patients (50.4%), and the highest incidence occurred in those over 50 years old (38.4%). Additionally, 17.7% of the reports were associated with serious events. The ROR was significant for the risk of pancreatitis when using DPP-4 (13.2, 95% confidence interval (CI) 11.84-14.70), while the ROR for GLP-1 was 9.65 (95% CI 9.17-10.16). The EBGM was highest with DPP-4 (12.25), followed by GLP-1 (8.64), while IC was highest with DPP-4 inhibitors (3.61). Liraglutide had the greatest association with pancreatitis among the GLP-1 RAs (ROR: 6.83, 95% CI 6.60-7.07).Conclusion: The findings show that pancreatitis has a strong link with DPP-4 inhibitors and GPL1 agonists, which pose a greater risk. Among the GLP-1 agonist medications, liraglutide has been found to have an association with pancreatitis.

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Model for predicting risk of developing drug-induced liver injury during remdesivir therapy: observational prospective open case-control study

Shevchuk,

Kryukov,

Temirbulatov

et al. 2023

Farm. farmakol. (Pâtigorsk)

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Remdesivir is a drug widely used for the etiotropic treatment of COVID-19. According to a number of studies, the incidence of adverse reactions during remdesivir therapy reaches 66%, with the most common is an increase in liver function tests.The aim of the work was to study the influence of clinical, demographic and pharmacogenetic factors on the development of drug-induced liver damage during remdesivir therapy in COVID-19 patients.Materials and methods. The study comprised 100 hospitalized patients treated with remdesivir. The patients were divided into two groups: group 1 (n=32) – remdesivir therapy, developed an increase in the level of liver transaminases; group 2 (control, n=68) – did not develop this adverse reaction. The patients in both groups underwent a pharmacogenetic study, and a retrospective analysis of medical records was performed. Based on the data obtained, the association of clinical, laboratory, pharmacological and pharmacogenetic parameters with the development of drug-induced liver damage during remdesivir therapy was studied.Results. In the group of patients with the development of drug-induced liver damage, people with a high body mass index were significantly more likely than in the control group (30.7±4.2 kg/m2 in group 1 vs. 27.3±5.5 kg/m2 in group 2, p=0.003), with a history of diabetes mellitus (odds ratio (OR)=2.647, 95% confidence interval (CI)=1.092–6.414, χ2=4.785, p=0.029), with higher levels of ferritin in the blood (724.03±432.27 and 553.19±358.48 mg/mol, respectively, p=0.040), receiving therapy with angiotensin-converting enzyme inhibitors (OR=5.440, 95% CI=2.160–13.699, χ2=14.027, p=0.000), statins (OR=3.148, 95% CI=1.307–7.581, χ2=6.795, p=0.009), and also being heterozygous for the polymorphic marker rs776746 of the CYP3A5 gene (OR=3.961, 95% CI=1.343–11.686, χ2=6.772, p=0.009).Conclusion. A high body mass index, a history of diabetes mellitus, high levels of ferritin in the blood, concomitant therapy with angiotensin-converting enzyme inhibitors and statins, as well as a carriage of the AG genotype for the polymorphic marker rs776746 of the CYP3A5 gene increase the likelihood of developing drug-induced liver damage during remdesivir therapy. In this regard, it is necessary to consider these factors when prescribing remdesivir therapy, conduct a more careful monitoring of clinical and laboratory indicators of liver damage, and develop personalized approaches to the treatment of COVID-19 patients.

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The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration’s Adverse Event Reporting System

Cited by 3 publications

References 28 publications

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system

Pancreatitis with use of new diabetic medications: a real-world data study using the post-marketing FDA adverse event reporting system (FAERS) database

Model for predicting risk of developing drug-induced liver injury during remdesivir therapy: observational prospective open case-control study

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