Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system

Frontiers in Public Health, Journal Year: 2022, Volume and Issue: 10

Published: Oct. 20, 2022

Background Semaglutide was approved for treatment of type 2 diabetes mellitus (T2DM) and chronic weight management in obesity or overweight adults. However, real-world data regarding its long-term gastrointestinal safety tolerability large sample population are incomplete. We evaluated semaglutide-associated signals by mining the FDA pharmacovigilance database. Methods Reporting odds ratio (ROR) employed to quantify semaglutide-related adverse events (AEs) from 2018 2022. Serious non-serious cases were compared Mann-Whitney U test Chi-squared (χ ) test, prioritized using a rating scale. Results identified 5,442 AEs, with 45 detected, ranging ROR 025 1.01 (hypoaesthesia oral) 42.03 (eructation), among which 17 AEs as new unexpected signals. Patient age ( p < 0.001) body = 0.006) rather than sex 0.251) might be associated an increased risk severity. Notably, association between semaglutide disorders remained when stratified age, weight, reporter type. One strong, 22 moderate weak clinical priority defined. The median time-to-onset (TTO) strong signal 23 days, while weak, they 6 7 respectively. All disproportionality had early failure features, suggesting that occurrence gradually decreased over time. Conclusion Our study provided deeper broader understanding semaglutide's profiles, would help healthcare professionals mitigate practice.

Language: Английский

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Feline Infectious Peritonitis: European Advisory Board on Cat Diseases Guidelines

Viruses, Journal Year: 2023, Volume and Issue: 15(9), P. 1847 - 1847

Published: Aug. 31, 2023

Feline coronavirus (FCoV) is a ubiquitous RNA virus of cats, which transmitted faeco-orally. In these guidelines, the European Advisory Board on Cat Diseases (ABCD) presents comprehensive review feline infectious peritonitis (FIP). FCoV primarily an enteric and most infections do not cause clinical signs, or result in only enteritis, but small proportion FCoV-infected cats develop FIP. The pathology FIP comprises perivascular phlebitis that can affect any organ. Cats under two years old are frequently affected by Most present with fever, anorexia, weight loss; many have effusions, some ocular and/or neurological signs. Making diagnosis complex ABCD Diagnostic Approach Tools available to aid veterinarians. Sampling effusion, when present, for cytology, biochemistry, antigen detection very useful diagnostically. absence fine-needle aspirates from organs cytology helpful. Definitive usually requires histopathology detection. Antiviral treatments now enable recovery cases this previously fatal disease; nucleoside analogues (e.g., oral GS-441524) effective, although they all countries.

Language: Английский

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Remdesivir: A Review in COVID-19

Drugs, Journal Year: 2023, Volume and Issue: 83(13), P. 1215 - 1237

Published: Aug. 17, 2023

Remdesivir (Veklury®), a nucleotide analogue prodrug with broad-spectrum antiviral activity, is approved for the treatment of coronavirus disease 2019 (COVID-19), illness caused by severe acute respiratory syndrome 2 infection. Unlike some antivirals, remdesivir has low potential drug-drug interactions. In pivotal ACTT-1 trial in hospitalized patients COVID-19, daily intravenous infusions significantly reduced time to recovery relative placebo. Subsequent trials provided additional support efficacy moderate or greater benefit seen minimal oxygen requirements at baseline. Clinical also demonstrated other patient populations, including outpatients high risk progression as well paediatric patients. terms mortality, results were equivocal. However, appeared have small mortality who not already being ventilated was generally tolerated clinical trials, but pharmacovigilance data found an increased hepatic, renal and cardiovascular adverse drug reactions real-world setting. conclusion, represents useful option particularly those require supplemental oxygen. Coronavirus (COVID-19) first reported China quickly spread around world. The symptoms COVID-19 can vary from person person, people having no others becoming very unwell. Most treat their home, may be admitted hospital and/or treated specialized medications such (Veklury®). medicine that reduce amount virus causes COVID-19. It given once day, usually 5–10 days, infusion. been shown improve children adolescents. death are before they start treatment. A 3-day course effective whose age underlying health puts them severely ill. tolerated. Therefore, especially

Language: Английский

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Remdesivir-induced severe hypoglycemia in an elderly man without diabetes: a case report

Journal of Pharmaceutical Health Care and Sciences, Journal Year: 2025, Volume and Issue: 11(1)

Published: Jan. 27, 2025

Language: Английский

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Retrospective study and outcome of 307 cats with feline infectious peritonitis treated with legally sourced veterinary compounded preparations of remdesivir and GS-441524 (2020–2022)

Journal of Feline Medicine and Surgery, Journal Year: 2023, Volume and Issue: 25(9)

Published: Sept. 1, 2023

Objectives Feline infectious peritonitis (FIP) is a serious disease that arises due to feline coronavirus infection. The nucleoside analogues remdesivir and GS-441524 can be effective in its treatment, but most studies have used unregulated products of unknown composition. aim the present study was describe treatment FIP using legally sourced veterinary-prescribed regulated veterinary compounded containing known amounts (injectable) or (oral tablets). Methods Cats were recruited via email advice services, product sales contacts publicity. excluded if they deemed unlikely FIP, not treated exclusively with products, there lack cat and/or (including response) data. Extensive data collected. Results Among 307 cats recruited, predominant type commonly abdominal effusive (49.5%) then neurological (14.3%). Three protocols used; alone (33.9%), followed by (55.7%) (10.4%). median (range) initial period duration longest follow-up time point after starting 84 (1–330) days 248 (1–814) days, respectively. common side effect injection pain (in 47.8% those given subcutaneous remdesivir). Of cats, 33 (10.8%) relapsed, 15 (45.5%) during 18 (54.5%) period. At completion period, 84.4% alive. achieving complete response within 30 significantly more likely alive at end than did not. Conclusions relevance Legally either sequentially, very this group cats. Variable precluded statistical comparison regimens.

Language: Английский

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COVID-19-associated AKI

Current Opinion in Critical Care, Journal Year: 2022, Volume and Issue: 28(6), P. 630 - 637

Published: Oct. 3, 2022

Purpose of review While it is now widely established acute kidney injury (AKI) a common and important complication coronavirus disease (COVID-19) disease, there marked variability in its reported incidence outcomes. This narrative provides mid-2022 summary the latest epidemiological evidence on AKI COVID-19. Recent findings Large observational studies meta-analyses report an 28–34% all inpatients 46–77% intensive care unit (ICU). The more severe requiring renal replacement therapy (RRT) ICU appears to have declined over time, data from England Wales RRT use 26% at start pandemic 14% 2022. majority survivors apparently recover their function by hospital discharge; however, these individuals appear remain increased risk future AKI, estimated glomerular filtration rate (eGFR) decline chronic disease. Importantly even absence overt significant proportion COVID-19 hospitalisation had reduced eGFR follow-up. Summary summarises epidemiology, factors, outcomes treatment COVID-19-associated across global pandemic. In particular long-term impact health uncertain requires further characterisation.

Language: Английский

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A real-world disproportionality analysis of Rucaparib: Post-marketing Pharmacovigilance Data

BMC Cancer, Journal Year: 2023, Volume and Issue: 23(1)

Published: Aug. 11, 2023

Rucaparib has been approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. However, long-term safety rucaparib in large sample population was unknown. The presented study aimed to evaluate rucaparib-associated adverse events (AEs) according real-world pharmacovigilance database.Disproportionality analysis conducted assess association between and its AEs. Data were collected from international database US FDA Adverse Event Reporting System (FAERS) January 2017 June 2022. characteristics rucaparib-related AEs, onset time further analyzed.A total 9,296,694 AE reports recorded FAERS during period, among which 7,087 associated rucaparib. About 135 signals 15 system organ class (SOCs) identified. most common AEs included anaemia, thrombocytopenia, nausea, vomiting, fatigue, blood creatinine increase, alanine aminotransferase aspartate listed label Of note, 21 new unexpected significant that off-label also found our study, such as preferred term (PTs) intestinal obstruction, gastrooesophageal reflux disease, iron decreased, dehydration, hypersomnia. median 12 days (interquartile range [IQR] 1-62 days), had early failure types.Our demonstrated potential rucaparib, studies expected confirm results.

Language: Английский

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Exploring the top 30 drugs associated with drug-induced constipation based on the FDA adverse event reporting system

Frontiers in Pharmacology, Journal Year: 2024, Volume and Issue: 15

Published: Sept. 2, 2024

Objective This project aims to identify the top 30 drugs most commonly associated with constipation and their signal values within FDA Adverse Event Reporting System database. Methods We extracted adverse drug events (ADEs) related from FAERS database spanning January 1, 2004, September 30, 2023. compiled frequently reported based on frequency of events. employed detection methodologies ascertain whether these elicited significant signals, including reporting odds ratio, proportional multi-item gamma Poisson shrinker, information component given by Bayesian confidence propagation neural network. Furthermore, we conducted a time-to-onset (TTO) analysis for generating signals using medians, quartiles, Weibull shape parameter test. Results total 50, 659, 288 ADEs, among which 169,897 (0.34%) were constipation. selected ranked drugs. The highest ranking was lenalidomide (7,730 cases, 4.55%), prevalent class being antineoplastic immunomodulating agents. Signal performed drugs, risk identified 26 them. Among 22 exhibited consistent those listed FDA-approved labels. However, four (orlistat, nintedanib, palbociclib, dimethyl fumarate) presented an unexpected Ranked values, sevelamer carbonate emerged as strongest [reporting ratio (95% CI): 115.51 (110.14, 121.15); PRR (χ 2 ): 83.78 (191,709.73); EBGM (EB05): 82.63 (79.4); IC (IC025): 6.37 (4.70)]. A TTO that generated revealing all early failure type. median orlistat 3 days, shortest while clozapine 1,065 longest Conclusion Our study provides list potentially drug-induced (DIC). could inform clinicians about some alternative medications consider when managing secondary causes or caring patients prone DIC, thereby reducing incidence mortality DIC.

Language: Английский

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Host-targeted antivirals against SARS-CoV-2 in clinical development - prospect or disappointment?

Antiviral Research, Journal Year: 2025, Volume and Issue: 235, P. 106101 - 106101

Published: Feb. 7, 2025

The global response to the COVID-19 pandemic, caused by novel SARS-CoV-2 virus, has seen an unprecedented increase in development of antiviral therapies. Traditional strategies have primarily focused on direct-acting antivirals (DAAs), which specifically target viral components. In recent years, increasing attention was given alternative approach aiming exploit host cellular pathways or immune responses inhibit replication, led so-called host-targeted (HTAs). emergence and promoted a boost this field. Numerous HTAs been tested demonstrated their potential against through vitro vivo studies. However, striking contrast, only limited number successfully progressed advanced clinical trial phases (2-4), even less entered practice. This review aims explore current landscape targeting that reached phase 2-4 trials. Additionally, it will challenges faced gaining regulatory approval market availability.

Language: Английский

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Gabapentinoids related psychiatric disorders: an analysis based on the FAERS database from 2004 to 2023

Expert Opinion on Drug Safety, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 9

Published: Jan. 3, 2025

Background Gabapentinoids, including gabapentin and pregabalin, are commonly used for neuropathic pain but have safety concerns. This study analyzed U.S. Food Drug Administration's (FDA) Adverse Event Reporting System (FAERS) data to assess risks of psychiatric disorders as adverse effects.

Language: Английский

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