abstract：:Introduction: Secukinumab is a fully human monoclonal antibody which targets and neutralizes interleukin (IL)-17A, a cytokine that plays an important role in the pathophysiology of ankylosing spondylitis (AS). Secukinumab is the first IL-17A inhibitor approved for the treatment of AS. Areas covered: This paper aimed t...

journal_title：Expert opinion on drug safety

authors： Loricera J,Galíndez-Aguirregoikoa E,Blanco R

更新日期：2021-01-20 00:00:00

abstract：:Background: This study aimed to measure the association of various H1-antihistamines (H1A) with Torsade de Pointes (TdP), and present a comprehensive overview of H1A-induced TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: All H1A-induced TdP cases (n = 406) were ...

journal_title：Expert opinion on drug safety

authors： Ali Z,Ismail M,Khan F,Sajid H

更新日期：2021-01-01 00:00:00

abstract：:Introduction: Intestinal failure-associated liver disease (IFALD) refers to hepatic dysfunction that results from prolonged parenteral nutrition (PN) use. IFALD is multifactorial in origin and remains a major cause of morbidity and mortality. Prior to 2004, IFALD was associated with mortality as high as 90% in infants...

journal_title：Expert opinion on drug safety

authors： Secor JD,Yu L,Tsikis S,Fligor S,Puder M,Gura KM

更新日期：2020-12-30 00:00:00

abstract：:Background: Erenumab has recently been approved as a pharmacological treatment for the prevention of migraine. However, the incidence estimates of adverse drug reactions (ADRs) were not consistent among studies. Consequently, pooled measures of the incidences of ADRs that accounts for inter-study heterogeneity are des...

journal_title：Expert opinion on drug safety

authors： Pellesi L,De Icco R,Alawie HY,Andersen M,Liang D,Amirguliyev S,Al-Karagholi MA,Amin FM,Sessa M

更新日期：2020-12-29 00:00:00

abstract：INTRODUCTION:During the last decade, the development of small molecule inhibitors of Janus kinases (JAKi) contributed to revolutionize the therapeutic landscape of myelofibrosis (MF). JAKi proved to be effective in controlling disease-related symptoms and splenomegaly with remarkable inter-drug variability. However, in...

journal_title：Expert opinion on drug safety

authors： Coltro G,Vannucchi AM

更新日期：2020-12-27 00:00:00

abstract：OBJECTIVES:To describe the cumulative incidences of adverse drug reactions (ADRs) associated with disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients from real-world data (RWD), using the DREAM-RA registry, and to compare these with incidence frequencies mentioned in the Summary of Pro...

journal_title：Expert opinion on drug safety

authors： Giraud EL,Jessurun NT,van Hunsel FPAM,van Puijenbroek EP,van Tubergen A,Ten Klooster PM,Vonkeman HE

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in in this population at risk of cardiovascular morbidity. ...

journal_title：Expert opinion on drug safety

authors： Luque-Ramírez M,Ortiz-Flores AE,Nattero-Chávez L,Escobar-Morreale HF

更新日期：2020-12-01 00:00:00

abstract：BACKGROUND:Critically ill patients receiving parenteral drugs are at an increased risk of exposure to various excipients administered simultaneously and at increased amounts. Hence, we carried out the present study. RESEARCH DESIGN AND METHODS:Patients admitted in the adult, pediatric, and neonatal intensive care unit...

journal_title：Expert opinion on drug safety

authors： Sridharan K,Hasan HM,Al Jufairi M,Al Daylami A,Al Ansari E,Qader AM,Pasha SAA

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:Adult onset Still disease (AOSD) is a rare systemic inflammatory condition. The clinical spectrum of this disease ranges from self-limiting forms with mild symptoms to life-threatening cases. Glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) represent the first line of therapy for AOSD, wi...

journal_title：Expert opinion on drug safety

authors： Cavalli G,Farina N,Campochiaro C,Baldissera E,Dagna L

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:ACE-inhibitors (ACEI) and diuretics are the typical first-line antihypertensive drugs with complementary mechanisms of action. The present paper is summarizing the evidence supporting the efficacy of their combination in a broad range of hypertensive patients. AREAS COVERED:This source of data is differen...

journal_title：Expert opinion on drug safety

authors： Borghi C,Soldati M,Bragagni A,Cicero AFG

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serotonin 5-HT1A agon...

journal_title：Expert opinion on drug safety

authors： Preda A,Shapiro BB

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:Approximately 40-50% of patients with cutaneous melanoma harbor point mutations in BRAF. BRAF and MEK inhibitors in combination are now a standard therapy for advanced BRAFV600-mutated melanoma. Nevertheless, survival rates with the combination are limited, highlighting the need for further therapeutic imp...

journal_title：Expert opinion on drug safety

authors： Indini A,Mandalà M

更新日期：2020-10-01 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: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：INTRODUCTION:Obesity is associated with an increased risk of cardiovascular morbidity and mortality. Four medications are approved by the US Food and Drug Administration (FDA) for chronic weight management when used as an adjunct to a reduced-calorie diet and increased physical activity in adults. These medications res...

journal_title：Expert opinion on drug safety

authors： Chao AM,Wadden TA,Berkowitz RI,Quigley K,Silvestry F

更新日期：2020-09-01 00:00:00

abstract：INTRODUCTION:Disease-modifying antirheumatic drugs (DMARDs) have significantly improved clinical symptoms and quality of life with reduced disease progression in many patients with rheumatoid arthritis (RA). Short-term glucocorticoid therapy is often used initially in combination with DMARDs, but some patients still ha...

journal_title：Expert opinion on drug safety

authors： Fleischmann R,Furst DE

更新日期：2020-08-01 00:00:00

abstract：INTRODUCTION:Immune checkpoint inhibitors (ICIs) have rapidly changed the treatment landscape, demonstrating dramatic clinical efficacy in various cancers. AREAS COVERED:In urothelial cancer (UC), several ICIs have been approved in platinum refractory disease and also as first-line therapy in patients that fulfill the...

journal_title：Expert opinion on drug safety

authors： Economopoulou P,Kotsantis I,Bamias A

更新日期：2020-08-01 00:00:00

abstract：:Objectives: To assess the risk of adverse events (AEs) associated with brentuximab vedotin in lymphoma patients.Methods: Articles were retrieved from PubMed, Cochrane, and Clinicaltrials Databases to identify randomized controlled trials (RCTs) comparing brentuximab vedotin with non-brentuximab vedotin in lymphoma pat...

journal_title：Expert opinion on drug safety

authors： Gao S,Zhang M,Wu K,Zhu J,He Z,Li J,Chen C,Qiu K,Yu X,Wu J

更新日期：2020-05-01 00:00:00

abstract：:Introduction: Psoriasis is a chronic inflammatory systemic disease that affects 2% of the population and is associated with an important physical and physiological burden. About 0.5-2% of psoriatic cases onset during the pediatric age range, and often it's not diagnosed until adulthood. Adalimumab is an antitumor necr...

journal_title：Expert opinion on drug safety

authors： Zangrilli A,Bavetta M,Bianchi L

更新日期：2020-04-01 00:00:00

abstract：:Introduction: Treatment for chronic pruritus ranges from use of topical formulations to newer biologic agents. Targeting treatment to the underlying etiology is key in reducing the burden of disease while avoiding systemic or adverse effects.Areas covered: This review details the effective medical treatments used in v...

journal_title：Expert opinion on drug safety

authors： Fourzali K,Yosipovitch G

更新日期：2020-04-01 00:00:00

abstract：:Introduction: Lacosamide has been used in epilepsy patients in the United States, Europe and Asia since it was approved by the FDA in 2008. Many patients have benefited from this drug as a new generation of sodium channel blocker. With the worldwide use of this drug, its adverse effects have gradually emerged, especia...

journal_title：Expert opinion on drug safety

authors： Li J,Sun M,Wang X

更新日期：2020-02-01 00:00:00

abstract：:Introduction: Botulinum toxin (BoNT) is a protein secreted by the anaerobic Gram-negative bacterium Clostridium botulinum. Among the seven known subtypes, type A is the most commonly used in women to treat diseases. It primarily blocks presynaptic release of acetylcholine at the neuromuscular junction, resulting in te...

journal_title：Expert opinion on drug safety

authors： Li W,Tang M

更新日期：2020-01-01 00:00:00

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：:Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, id...

journal_title：Expert opinion on drug safety

authors： Ashida K,Honda Y,Sanada K,Takemura Y,Sakamoto S

更新日期：2019-12-01 00:00:00

abstract：:Introduction: Patients living with schizophrenia have a marked risk of clinically significant weight gain and obesity compared to the general population. The risks have been highlighted following the introduction of second-generation antipsychotics. In turn, obesity is associated with a higher prevalence of cardiovasc...

journal_title：Expert opinion on drug safety

authors： Marteene W,Winckel K,Hollingworth S,Kisely S,Gallagher E,Hahn M,Ebdrup BH,Firth J,Siskind D

更新日期：2019-12-01 00:00:00

abstract：:Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of...

journal_title：Expert opinion on drug safety

authors： Ferraro S,Convertino I,Leonardi L,Blandizzi C,Tuccori M

更新日期：2019-12-01 00:00:00

abstract：:Introduction: The use of testosterone therapy (TTh) in men with prostate cancer (PCa) is relatively new, and controversial, due to the longstanding maxim that TTh is contraindicated in men with PCa. Scientific advances have prompted a reevaluation of the potential role for TTh in men with PCa, particularly as TTh has ...

journal_title：Expert opinion on drug safety

authors： Morgentaler A,Caliber M

更新日期：2019-11-01 00:00:00

abstract：:Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporti...

journal_title：Expert opinion on drug safety

authors： Carnovale C,Mazhar F,Arzenton E,Moretti U,Pozzi M,Mosini G,Leoni O,Scatigna M,Clementi E,Radice S

更新日期：2019-11-01 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: Cutaneous T-cell lymphomas (CTCL) are rare non-Hodgkin lymphomas of skin-homing T-cells that initially or mainly manifest cutaneously. Treatment of CTCL is challenging given the disease states' varying presentation and prognosis. Systemic treatment options often lack comparative evidence and have relativ...

journal_title：Expert opinion on drug safety

authors： Afifi S,Mohamed S,Zhao J,Foss F

更新日期：2019-09-01 00:00:00

abstract：INTRODUCTION:Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different ...

journal_title：Expert opinion on drug safety

authors： Bassetti M,Peghin M,Castaldo N,Giacobbe DR

更新日期：2019-08-01 00:00:00

abstract：INTRODUCTION:Oral antidiabetic medications are important in many type 2 diabetes care plans. AREAS COVERED:The article summarizes the cardiovascular and renal safety data for DPP-4 inhibitors and SGLT-2 inhibitors and specific safety data particular to each class. EXPERT OPINION:DPP-4 and SGLT-2 inhibitors provide un...

journal_title：Expert opinion on drug safety

authors： Lamos EM,Hedrington M,Davis SN

更新日期：2019-08-01 00:00:00

abstract：INTRODUCTION:Cardiovascular (CV) diseases are the leading cause of death and disability in the developed countries. Lipid-lowering therapy is a cornerstone of the CV risk modification strategy. The first line treatment for hyperlipidemia is statins, which decrease low-density lipoprotein cholesterol (LDL-C) by 30-50% a...

journal_title：Expert opinion on drug safety

authors： Strilchuk L,Fogacci F,Cicero AF

更新日期：2019-07-01 00:00:00

abstract：:Objectives: Bullous pemphigoid, an autoimmune dermatological disease, may be associated with the use of a relatively new anti-cancer drug class, PD-1 inhibitors, which includes pembrolizumab and nivolumab. This paper analyzes the signals between PD-1 inhibitors and bullous pemphigoid based upon the reported real-world...

journal_title：Expert opinion on drug safety

authors： Aggarwal P

更新日期：2019-07-01 00:00:00

abstract：:Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database. Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or...

journal_title：Expert opinion on drug safety

authors： Wei R,Jia LL,Yu YC,Nie XL,Song ZY,Fan DF,Xie YF,Peng XX,Zhao ZG,Wang XL

更新日期：2019-05-01 00:00:00

abstract：INTRODUCTION:The introduction of pneumococcal conjugate vaccines (PCVs) in the routine immunization program has resulted in a significant decline in invasive pneumococcal diseases (IPD) around the world. Preterm infants are a special group at a high risk of invasive infection by encapsulated bacteria. However, their sl...

journal_title：Expert opinion on drug safety

authors： López-Sanguos C,Rivero Calle I,Rodriguez Tenreiro C,Raguindin PF,Martinón-Torres F

更新日期：2019-04-01 00:00:00

abstract：BACKGROUND:To perform an international comparison and analysis of celecoxib spontaneous adverse event reports (AERs) from Canada, Australia and the United States, focusing on gastrointestinal, renal and cardiovascular events. This study also examined concomitant medicines use which may have potentiated the risk of the ...

journal_title：Expert opinion on drug safety

authors： Baselyous Y,De Cocinis M,Ibrahim M,Kalra A,Yacoub R,Ahmed R

更新日期：2019-03-01 00:00:00

abstract：INTRODUCTION:Unintended harm from prescribing errors remains a prevalent concern in healthcare leading to significant morbidity and mortality around the world. Prescribers face new challenges to their practice in modern times such as increasingly complex health-care systems, an aging population with increasing multimor...

journal_title：Expert opinion on drug safety

authors： Coleman JJ

更新日期：2019-02-01 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：:Introduction: Rucaparib is increasingly being utilized for women with recurrent ovarian cancer both as treatment and maintenance therapy. Poly-ADP ribose polymerase (PARP) inhibitors like rucaparib are daily oral medication that exploit the DNA repair pathway. The most significant clinical benefit is in those tumors e...

journal_title：Expert opinion on drug safety

authors： Cosgrove CM,O'Malley DM

更新日期：2018-12-01 00:00:00