Hepatic Safety Profile of Atomoxetine and Methylphenidate in Patients with ADHD: Disproportionality Analysis Using EudraVigilance Database Data [PDF]
PharmaceuticalsBackground: Hepatotoxicity induced by atomoxetine (ATX) and methylphenidate (MPH) when used to treat ADHD is a rare but potentially serious complication.
Raffaella Di Napoli +6 more
doaj +3 more sources
Pharmaceutics, 2023 Risankizumab is a selective, humanized immunoglobulin G1 (IgG1) monoclonal anti-body directed against interleukin (IL)-23 protein. The therapeutic indication of risankizumab is moderate-to-severe plaque psoriasis and psoriatic arthritis.
Fabrizio Calapai +6 more
doaj +2 more sources
COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature [PDF]
International Journal of Cardiology: Heart & Vasculature, 2023 Background: Myocarditis secondary to Coronavirus Disease 2019 (COVID-19) vaccination has been reported in the literature. Objective: This study aimed to characterize the reported cases of myocarditis after COVID-19 vaccination based on age, gender, doses,
Vikash Jaiswal +13 more
doaj +3 more sources
Gender and age variations in neuropsychiatric adverse events of cetirizine and levocetirizine: a disproportionality analysis of ICSRs from FAERS and EudraVigilance data [PDF]
Frontiers in PharmacologyBackgroundThis study analyzed neuropsychiatric adverse drug events (ADEs) associated with cetirizine and levocetirizine using data from the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases to inform safer clinical use for different
Tingting Yang +9 more
doaj +2 more sources
Higher disease reactivation risk in women after fingolimod withdrawal [PDF]
Acta Neuropathologica CommunicationsBackground Disease reactivation following cessation of sphingosine 1-phosphate receptor modulators (S1PRM) occurs in ~ 10% of multiple sclerosis (MS) patients.
Marine Massy +12 more
doaj +2 more sources
Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis [PDF]
Virology JournalBackground Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) has demonstrated strong efficacy and favorable tolerability as a first-line HIV treatment.
Yuxin Xie +8 more
doaj +2 more sources
Therapeutic Advances in Drug Safety, 2019 Different strategies have been studied to allow a better characterization of the safety profile of orphan drugs soon after their approval. At the end of the development phases only few data are available because of the small number of subjects exposed to
Marco Sardella
exaly +2 more sources
Neuroleptic malignant syndrome associated with second-generation antipsychotics (SGA): An analysis of reported cases in eudravigilance database, 2017-2020 [PDF]
European Psychiatry, 2021 Introduction Antipsychotic drugs are the cornerstone of the pharmacological treatment of psychotic disorders; however, even with Second-generation antipsychotics (SGA), adverse effects continue to be extremely accentuated and the treatment ...
A. Torres +6 more
doaj +2 more sources
LifeBackground: The coronavirus disease 2019 (COVID-19) pandemic presented a new challenge in modern medicine: the development of vaccines was followed by massive population vaccinations.
Jan Romantowski +4 more
doaj +2 more sources
Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database
Clinical Epidemiology and Global HealthBackground: Tirzepatide has demonstrated superior efficacy in glycemic control and weight reduction compared to existing GLP-1 receptor agonists. However, its safety profile remains to be fully elucidated in real-world settings.
Atul Khurana +7 more
doaj +2 more sources