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 reported adverse events. Research, design and methods: Three databases were searched for spontaneous AERs associated with celecoxib, submitted within the past 10 years: Australian Therapeutic Goods Administration Database of Adverse Event Notifications; Canada Vigilance Adverse Reaction Online Database; and the United States Food and Drug Administration Adverse Event Reporting System Database. Analysis of the AERs focussed on the identification of gastrointestinal, cardiovascular and renal adverse events and concomitant medications suspected of potentiating adverse event risks. RESULTS:A total of 24,232 celecoxib AERs were identified. Gastrointestinal disorders were the most frequently reported adverse events at the system organ class (SOC) level in the AERs. A large number of AERs documented the use of potentially inappropriate concomitant medicines which may have increased the risk of the reported adverse events. CONCLUSIONS:The large number of reports that involved a concomitant medicine that was in contravention with prescribing guidelines indicates an increased need for efforts to support the safe prescribing of celecoxib.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Baselyous Y,De Cocinis M,Ibrahim M,Kalra A,Yacoub R,Ahmed Rdoi
10.1080/14740338.2019.1589447subject
Has Abstractpub_date
2019-03-01 00:00:00pages
153-161issue
3eissn
1474-0338issn
1744-764Xjournal_volume
18pub_type
杂志文章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
pub_type: 杂志文章
doi:10.1080/14740338.2020.1832990
更新日期:2020-12-01 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
pub_type: 杂志文章
doi:10.1517/14740338.2014.941804
更新日期:2014-09-01 00:00:00
abstract:INTRODUCTION:The management of lupus nephritis (LN) has changed significantly over the last 10 years due to emerging evidence from large randomised clinical trials that produced good quality data and guided the formulation of two key concepts: the induction of remission and the maintenance phase of immunosuppressive th...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1182496
更新日期:2016-08-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2019.1676722
更新日期:2019-12-01 00:00:00
abstract:BACKGROUND:Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES:The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS:This was a retrospective study conducted at the Departmen...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1226279
更新日期:2016-11-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2020.1830058
更新日期:2020-12-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Bisphosphonates are the most widely used antiresorptive agents for the treatment of osteoporosis. However, the cumulative bisphoshonate exposure and its association with atypical fragility fractures, and the optimum duration of treatment remain obscure. AREAS COVERED IN THIS REVIEW:This review ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2010.517192
更新日期:2011-01-01 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
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1666103
更新日期:2019-11-01 00:00:00
abstract::Bone morphogenetic proteins (BMPs) have been extensively studied since the discovery of agents within bone that could induce bone formation at ectopic sites by Urist in the 1960s. Extensive preclinical research has been carried out showing the efficacy of these products in promoting bone healing. Clinical trials are e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.1.75
更新日期:2005-01-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.2.5.495
更新日期:2003-09-01 00:00:00
abstract::An unprecedented interest in biomarker development has arisen from the increasing use of genomic information and high-throughput technologies in the field of drug development. Monitoring global cellular responses to perturbation due to disease, drug treatment or toxicity is achieved using molecular profiling methods s...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/eods.3.2.137.27344
更新日期:2004-03-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.6.713
更新日期:2007-11-01 00:00:00
abstract:INTRODUCTION:The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to di...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1341872
更新日期:2017-08-01 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
pub_type: 杂志文章,meta分析,评审
doi:10.1517/14740338.2015.1085969
更新日期:2015-10-01 00:00:00
abstract::Of the numerous topics discussed during the eighth annual meeting of the Safety Pharmacology (SP) Society the author identified the following key topics: i) the impact of hERG (human ether-à-go-go related gene) channel data on drug development, ii) safety evaluation of biological products, iii) opportunities and expec...
journal_title:Expert opinion on drug safety
pub_type:
doi:10.1517/14740330902760360
更新日期:2009-03-01 00:00:00
abstract::Self-medication, using non-prescription drugs, is beneficial to patients, healthcare professionals, the pharmaceutical industry and governments. Although many non-prescription medications are effective, misuse and abuse of these products can arise. Monitoring of specific populations and products, in addition to data r...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.2.1.1
更新日期:2003-01-01 00:00:00
abstract:INTRODUCTION:Epidural steroid injections (ESI) are a commonly utilized treatment for cervical and lumbar radicular pain. All medical procedures and medications carry an inherent level of risk, that must be balanced with the effectiveness of the treatment to determine the risk to benefit ratio for a patient. AREAS COVE...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1184246
更新日期:2016-08-01 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
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1643837
更新日期:2019-09-01 00:00:00
abstract:INTRODUCTION:To discuss the significance of the recent observational case series from the Swiss Toxicological Information Centre (STIC). Mycophenolic acid (MPA) and its prodrug mycophenolate mofetil are immunosuppressive agents that are frequently prescribed in renal transplant recipients, and their safety profiles mus...
journal_title:Expert opinion on drug safety
pub_type: 评论,社论
doi:10.1517/14740338.2014.905540
更新日期:2014-05-01 00:00:00
abstract::The use of warfarin in the elderly, particularly for stroke prevention in chronic atrial fibrillation, is steadily increasing. Although the benefits of warfarin are greatest in the elderly, so are the risk of adverse outcomes and the difficulties of anticoagulant management. Clinical systems need to improve to counter...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.3.417
更新日期:2006-05-01 00:00:00
abstract:INTRODUCTION:Traditional Chinese medicine (TCM) is widely used around the world. However, with its wide use has been the identification of a number of toxicological issues that have severely restricted its use in clinical treatment. The identification of these toxic substances within TCM has become somewhat of a hot to...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.726610
更新日期:2012-11-01 00:00:00
abstract:INTRODUCTION:In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951326
更新日期:2014-12-01 00:00:00
abstract:INTRODUCTION:Gestational diabetes mellitus (GDM), the most frequent medical complication of pregnancy, is associated with several adverse outcomes over the short- and long-term for both mother and offspring. Standard treatment for GDM consists of insulin injections. Oral hypoglycemic agents (OHAs), on the other hand, a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.521740
更新日期:2011-03-01 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
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1512969
更新日期:2018-09-01 00:00:00
abstract::This meeting was convened to encourage the incorporation of empirical and mechanism-based pharmacokinetic/pharmacodynamic (PK/PD) modelling into safety pharmacology to improve the predictability of nonclinical investigations for human outcomes. These technologies make use of mathematical expressions relating measured ...
journal_title:Expert opinion on drug safety
pub_type:
doi:10.1517/14740338.6.4.465
更新日期:2007-07-01 00:00:00
abstract:INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.897328
更新日期:2014-04-01 00:00:00
abstract::Methotrexate is a commonly prescribed antineoplastic and immune modulating compound that has gained wide acceptance in the management of rheumatoid arthritis, psoriasis, sarcoidosis and a number of neoplastic disorders. Although generally considered safe and easy to use, methotrexate has been associated with a number ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.4.723
更新日期:2005-07-01 00:00:00
abstract:INTRODUCTION:Guselkumab is a fully human monoclonal IgG1λ antibody for the treatment of plaque psoriasis that inhibits interleukin (IL)-23p19 subunit, reducing the proliferation of type 17 helper T (Th-17) cells and thus production of Th-17-derived pro-inflammatory cytokines, especially IL-17 and IL-22. Areas covered: ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1488963
更新日期:2018-07-01 00:00:00
abstract:INTRODUCTION:Many commonly used drugs have primary or secondary anticholinergic effects contributing to adverse outcomes ranging from mild-to-severe to potentially lethal. Anticholinergic adverse effects frequently occur with medications prescribed with other intended mechanisms of action, including antihistamines, ant...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.579899
更新日期:2011-09-01 00:00:00
abstract::The non-nucleoside analogue inhibitor of the reverse transcriptase, efavirenz (EFV), has become commonly used in highly active antiretroviral combination therapy in the treatment of HIV infection. Although being effective in suppressing plasma viral load, neuropsychiatric side effects have been reported in individuals...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.2.147
更新日期:2007-03-01 00:00:00