Possible effects of excipients used in the parenteral drugs administered in critically ill adults, children, and neonates.

abstract：:Introduction: Clozapine remains the most effective antipsychotic for treatment-refractory schizophrenia. However, ~40% of the patients respond insufficiently to clozapine. Clozapine's effects, both beneficial and adverse, have been proposed to be partially attributable to its main metabolite, N-desmethylclozapine (NDM...

journal_title：Expert opinion on drug safety

authors： Costa-Dookhan KA,Agarwal SM,Chintoh A,Tran VN,Stogios N,Ebdrup BH,Sockalingam S,Rajji TK,Remington GJ,Siskind D,Hahn MK

更新日期：2020-01-01 00:00:00

abstract：:Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases. GlaxoSmithKline (GSK) has > 100 drugs marketed worldwide. In order to determine which database has the highest statistical power to detect safety signals in three larg...

journal_title：Expert opinion on drug safety

authors： Hammond IW,Gibbs TG,Seifert HA,Rich DS

更新日期：2007-11-01 00:00:00

abstract：:Folic acid supplementation has drawn much attention in recent years for the prevention of Alzheimer's disease and cognitive decline. In this review, the authors describe how current evidence does not support the use of folic acid supplements to protect against cognitive decline. Although a few studies suggest that fol...

journal_title：Expert opinion on drug safety

authors： Schneider JA,Tangney CC,Morris MC

更新日期：2006-07-01 00:00:00

abstract：INTRODUCTION:In the 1980s-1990s numerous studies were performed on H2-receptor antagonist inhibition of ethanol first-pass metabolism. Blood alcohol concentrations warranting possible driving under the influence citations in the United States have subsequently dropped from ≥100 mg/dL to 50 mg/dL (Utah in 2019) (30 mg/d...

journal_title：Expert opinion on drug safety

authors： Moody DE

更新日期：2018-09-01 00:00:00

abstract：INTRODUCTION:Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED:Pembrolizumab was appr...

journal_title：Expert opinion on drug safety

authors： Mishima S,Kawazoe A,Shitara K

更新日期：2020-09-01 00:00:00

abstract：OBJECTIVE:Attention deficit hyperactivity disorder (ADHD) is the most common psychiatric childhood disorder. The most commonly used drugs in the treatment of ADHD are methylphenidate (MPH) and atomoxetine (ATX); the former of the two is prescribed in USA more than it is in Western Europe. Some of the most important saf...

journal_title：Expert opinion on drug safety

authors： Capuano A,Scavone C,Rafaniello C,Arcieri R,Rossi F,Panei P

更新日期：2014-09-01 00:00:00

abstract：:Medication-induced oesophageal distress and injury have become increasingly common conditions. First, smooth muscle relaxants may worsen or produce symptoms of pre-existing gastro-oesophageal reflux disease; notable examples include certain calcium antagonists (nifedipine), nitrates, sildenafil, nicotine, theophylline...

journal_title：Expert opinion on drug safety

authors： Petersen KU,Jaspersen D

更新日期：2003-09-01 00:00:00

abstract：BACKGROUND:This meta-analysis has been conducted to determine the risk of elevated transaminases associated with immune checkpoint inhibitors use in patients with cancer. METHODS:Studies eligible for our analysis included randomized Phase II and III trials of patients with cancer on ipilimumab, nivolumab, pembrolizuma...

journal_title：Expert opinion on drug safety

authors： Abdel-Rahman O,ElHalawani H,Fouad M

更新日期：2015-10-01 00:00:00

abstract：INTRODUCTION:Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumor. Its action is mediated by its affinity to somatostatin receptors, especially sst2 and ...

journal_title：Expert opinion on drug safety

authors： Godara A,Siddiqui NS,Byrne MM,Saif MW

更新日期：2019-01-01 00:00:00

abstract：:The epidemiology, natural history and efficacy of treatment for chronic hepatitis C in children are presented. An increase in the number of vertical infections of this etiology is suggested. In children, especially in those vertically infected, spontaneous elimination of hepatitis C virus (HCV) is observed more often ...

journal_title：Expert opinion on drug safety

authors： Pawlowska M

更新日期：2015-03-01 00:00:00

abstract：:The problem of counterfeit drugs is increasingly becoming a top priority of drug regulatory agencies, licit pharmaceutical manufacturers and healthcare professionals, and is of rising concern among consumers. A review of the current literature reveals that counterfeiting is no longer isolated in developing nations, bu...

journal_title：Expert opinion on drug safety

authors： Wertheimer AI,Santella TM

更新日期：2005-07-01 00:00:00

abstract：:Worldwide, women comprise > 50% of all people living with HIV and the vast majority of these women are of childbearing age. In fact, a significant proportion of these women are identified as HIV-infected during pregnancy. Preventing perinatal transmission has been one of the greatest prevention successes of the HIV ep...

journal_title：Expert opinion on drug safety

authors： Nurutdinova D,Overton ET

更新日期：2009-11-01 00:00:00

abstract：INTRODUCTION:Hydroxychloroquine (HCQ) is an alkalinizing lysosomatropic drug that accumulates in lysosomes where it inhibits some important functions by increasing the pH. HCQ has proved to be effective in a number of autoimmune diseases including systemic lupus erythematosus (SLE). Areas covered: In this review the me...

journal_title：Expert opinion on drug safety

authors： Ponticelli C,Moroni G

更新日期：2017-03-01 00:00:00

abstract：:Most available antimalarial drugs induce cardiac side effects. These side effects include various mild heart rate changes (amodiaquine) to excessive prolongation of the QT interval (halofantrine) which may lead to lethal arrhythmias such as Torsade de Pointes (TdP). The cellular mechanism of such events during antimal...

journal_title：Expert opinion on drug safety

authors： Traebert M,Dumotier B

更新日期：2005-05-01 00:00:00

abstract：INTRODUCTION:Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical appli...

journal_title：Expert opinion on drug safety

authors： Geng R,Song L,Li J,Zhao L

更新日期：2018-11-01 00:00:00

abstract：INTRODUCTION:The Annual Meeting of the Safety Pharmacology (SP) Society is a yearly event designed to keep attendees abreast of how to best identify and mitigate organ function liabilities of candidate drugs selected for clinical assessment. AREAS COVERED:Heart rate (HR) and blood pressure (BP) effects of candidate dr...

journal_title：Expert opinion on drug safety

authors： Cavero I

更新日期：2015-06-01 00:00:00

abstract：INTRODUCTION:Albiglutide is a marketed long acting GLP-1 receptor agonist (GLP-1 RA) administered by weekly injection. It has significantly less gastrointestinal side effects than other GLP-1 RAs in current use but does not improve HbA1c or promote weight loss to the same extent as competitor agents such as liraglutide...

journal_title：Expert opinion on drug safety

authors： Rendell MS

更新日期：2017-09-01 00:00:00

abstract：INTRODUCTION:Secondary preventative therapies are essential for patients undergoing coronary artery bypass graft (CABG) surgery to optimize perioperative and long-term outcomes. Beta-blockers are commonly used to treat patients with coronary artery disease and congestive heart failure (CHF), but their role for CABG pat...

journal_title：Expert opinion on drug safety

authors： Thaper A,Kulik A

更新日期：2018-08-01 00:00:00

abstract：INTRODUCTION:Although antidepressant (AD) monotherapy is recommended first-line for major depressive disorder (MDD), AD + AD co-treatment is common. AREAS COVERED:We conducted the first systematic review searching PubMed/MEDLINE/PsycInfo/Embase from database inception until 1 June 2015 for acute randomized trials in ≥...

journal_title：Expert opinion on drug safety

authors： Galling B,Calsina Ferrer A,Abi Zeid Daou M,Sangroula D,Hagi K,Correll CU

更新日期：2015-10-01 00:00:00

abstract：INTRODUCTION:Trabectedin gained the approval by the European Medicines Agency (EMA) in 2007 for the treatment of patients affected by soft-tissue sarcomas (STS). Its safety and activity profiles have been assessed in many clinical trials as well as in standard clinical practice for > 10 years. AREAS COVERED:This artic...

journal_title：Expert opinion on drug safety

authors： Martin-Liberal J,Judson I

更新日期：2013-11-01 00:00:00

abstract：INTRODUCTION:The antimalarial drug hydroxychloroquine (HCQ) is widely used to treat various rheumatic diseases. Many autoimmune diseases occur in women of child-bearing age who may become pregnant while on therapy, which raises concerns regarding the teratogenicity of HCQ and its effect on the outcome of the pregnancy....

journal_title：Expert opinion on drug safety

authors： Abarientos C,Sperber K,Shapiro DL,Aronow WS,Chao CP,Ash JY

更新日期：2011-09-01 00:00:00

abstract：INTRODUCTION:Hepatitis C virus is a hepatotropic virus that generally leads to chronic hepatitis and various harmful sequelae. The lone standard of treatment has been pegylated interferon and ribavirin, which produces a modest response and many side effects. However, a new era of management was declared with the introd...

journal_title：Expert opinion on drug safety

authors： El Kassas M,Elbaz T,Hafez E,Esmat G

更新日期：2016-12-01 00:00:00

abstract：:Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in ...

journal_title：Expert opinion on drug safety

authors： Miranda MRH,Dubey A,G S R,Charyulu RN

更新日期：2019-10-01 00:00:00

abstract：INTRODUCTION:In the last couple of years, the number of patients with chronic inflammatory rheumatic diseases being treated with TNF α antagonist has increased dramatically. Adalimumab, a fully human monoclonal antibody against TNF α, is one of the most frequently administered TNF α antagonists. Yet, unresolved issues ...

journal_title：Expert opinion on drug safety

authors： Poddubnyy D,Rudwaleit M

更新日期：2011-07-01 00:00:00

abstract：OBJECTIVE:To review long-term safety data from the rollover study ETV-901, focusing on adverse events (AEs) with a potential nucleos(t)ide association. METHODS:The open-label study ETV-901 (AI463901) assessed the safety of entecavir in chronic hepatitis B patients who received entecavir, lamivudine or adefovir monothe...

journal_title：Expert opinion on drug safety

authors： Manns MP,Akarca US,Chang TT,Sievert W,Yoon SK,Tsai N,Min A,Pangerl A,Beebe S,Yu M,Wongcharatrawee S

更新日期：2012-05-01 00:00:00

abstract：OBJECTIVES:Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying wheth...

journal_title：Expert opinion on drug safety

authors： Magro L,Arzenton E,Moretti U,Sottosanti L,Potenza S,Leone R

更新日期：2016-12-01 00:00:00

abstract：INTRODUCTION:Clozapine was first introduced as an antipsychotic in the 1970's but a cluster of deaths, later linked to the drug's risk of agranulocytosis, led to its withdrawal in most countries. However, work in the 1980's established its unique efficacy in treatment resistant schizophrenia (TRS), which constitutes as...

journal_title：Expert opinion on drug safety

authors： Remington G,Lee J,Agid O,Takeuchi H,Foussias G,Hahn M,Fervaha G,Burton L,Powell V

更新日期：2016-09-01 00:00:00

abstract：INTRODUCTION:Patients with end-stage renal disease (ESRD) are considered at higher risk of influenza-related complications and are listed worldwide among the subjects for whom yearly influenza vaccination is strongly recommended. However, influenza vaccination coverage of patients with ESRD is significantly lower than ...

journal_title：Expert opinion on drug safety

authors： Principi N,Esposito S,ESCMID Vaccine Study Group (EVASG).

更新日期：2015-08-01 00:00:00

abstract：INTRODUCTION:Since calcitonin gene-related peptide (CGRP) plays an important role in the pathophysiology of migraine via the activation of the trigeminovascular system, the newest prophylactic treatments directly block CGRP or its receptor. However, the safety of these novel antimigraine drugs is not yet sufficiently e...

journal_title：Expert opinion on drug safety

authors： Rivera-Mancilla E,Villalón CM,MaassenVanDenBrink A

更新日期：2020-10-01 00:00:00

abstract：INTRODUCTION:Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor (IL-2R). When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later, basiliximab saturates the alpha chain of IL-2R for 4 weeks. AREAS COVERED:This review eval...

journal_title：Expert opinion on drug safety

authors： Ponticelli C

更新日期：2014-03-01 00:00:00