Potentially inappropriate concomitant medicine use with the selective COX-2 inhibitor celecoxib: Analysis and comparison of spontaneous adverse event reports from Australia, Canada and the USA.

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 Saf

authors

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

doi

10.1080/14740338.2019.1589447

subject

Has Abstract

pub_date

2019-03-01 00:00:00

pages

153-161

issue

3

eissn

1474-0338

issn

1744-764X

journal_volume

18

pub_type

杂志文章
  • A safety evaluation of aripiprazole in the treatment of schizophrenia.

    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

    authors: Preda A,Shapiro BB

    更新日期:2020-12-01 00:00:00

  • Atomoxetine in the treatment of attention deficit hyperactivity disorder and suicidal ideation.

    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

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

    更新日期:2014-09-01 00:00:00

  • The safety of pharmacological treatment options for lupus nephritis.

    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

    authors: Velo-García A,Ntatsaki E,Isenberg D

    更新日期:2016-08-01 00:00:00

  • The safety and effectiveness of vonoprazan-based Helicobacter pylori eradication therapy; a prospective post-marketing surveillance.

    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

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

    更新日期:2019-12-01 00:00:00

  • Efficacy and safety of infliximab in psoriatic patients over the age of 65.

    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

    authors: Chiricozzi A,Pavlidis A,Dattola A,Bianchi L,Chimenti MS,Fida M,Saraceno R

    更新日期:2016-11-01 00:00:00

  • Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients.

    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

    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

  • Fracture risk associated with chronic use of bisphosphonates: evidence today.

    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

    authors: Charopoulos I,Orme S,Giannoudis PV

    更新日期:2011-01-01 00:00:00

  • Safety of testosterone therapy in men with prostate cancer.

    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

    authors: Morgentaler A,Caliber M

    更新日期:2019-11-01 00:00:00

  • Application of bone morphogenetic proteins in orthopaedic practice: their efficacy and side effects.

    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

    authors: Harwood PJ,Giannoudis PV

    更新日期:2005-01-01 00:00:00

  • Medication-induced oesophageal disorders.

    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

    authors: Petersen KU,Jaspersen D

    更新日期:2003-09-01 00:00:00

  • Molecular profiling approaches for identifying novel biomarkers.

    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

    authors: Bailey WJ,Ulrich R

    更新日期:2004-03-01 00:00:00

  • Database size and power to detect safety signals in pharmacovigilance.

    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

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

    更新日期:2007-11-01 00:00:00

  • The risks associated with prenatal antidepressant exposure: time for a precision medicine approach.

    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

    authors: Pedersen LH

    更新日期:2017-08-01 00:00:00

  • Risk of elevated transaminases in cancer patients treated with immune checkpoint inhibitors: a meta-analysis.

    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

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

    更新日期:2015-10-01 00:00:00

  • Safety Pharmacology Society: 8th annual meeting.

    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

    authors: Cavero I,Safety Pharmacology Society.

    更新日期:2009-03-01 00:00:00

  • Monitoring self-medication.

    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

    authors: Hughes CM

    更新日期:2003-01-01 00:00:00

  • Safety of epidural steroid injections.

    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

    authors: Schneider B,Zheng P,Mattie R,Kennedy DJ

    更新日期:2016-08-01 00:00:00

  • A drug safety evaluation of mogamulizumab for the treatment of cutaneous T-Cell lymphoma.

    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

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

    更新日期:2019-09-01 00:00:00

  • Do we need to worry about mycophenolate overdose?

    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

    authors: Filler G,Ferrand A

    更新日期:2014-05-01 00:00:00

  • The risks of warfarin use in the elderly.

    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

    authors: Bereznicki LR,Peterson GM,Jackson SL,Jeffrey EC

    更新日期:2006-05-01 00:00:00

  • Typical toxic components in traditional Chinese medicine.

    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

    authors: Lv W,Piao JH,Jiang JG

    更新日期:2012-11-01 00:00:00

  • Safety considerations when prescribing immunosuppression medication to pregnant women.

    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

    authors: Gerosa M,Meroni PL,Cimaz R

    更新日期:2014-12-01 00:00:00

  • Oral hypoglycemic agents for gestational diabetes mellitus?

    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

    authors: Maymone AC,Baillargeon JP,Ménard J,Ardilouze JL

    更新日期:2011-03-01 00:00:00

  • The inhibition of first-pass metabolism of ethanol by H2-receptor antagonists: a tabulated review.

    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

    authors: Moody DE

    更新日期:2018-09-01 00:00:00

  • Using pharmacokinetic/pharmacodynamic modelling in safety pharmacology to better define safety margins: a regional workshop of the Safety Pharmacology Society.

    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

    authors: Cavero I

    更新日期:2007-07-01 00:00:00

  • Safety of carbonic anhydrase inhibitors.

    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

    authors: Swenson ER

    更新日期:2014-04-01 00:00:00

  • Methotrexate pulmonary toxicity.

    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

    authors: Lateef O,Shakoor N,Balk RA

    更新日期:2005-07-01 00:00:00

  • A safety evaluation of guselkumab for the treatment of psoriasis.

    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

    authors: Galluzzo M,D'Adamio S,Campione E,Bianchi L,Talamonti M

    更新日期:2018-07-01 00:00:00

  • Drugs with anticholinergic properties: a current perspective on use and safety.

    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

    authors: Gerretsen P,Pollock BG

    更新日期:2011-09-01 00:00:00

  • Neuropsychiatric side effects of efavirenz therapy.

    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

    authors: Arendt G,de Nocker D,von Giesen HJ,Nolting T

    更新日期:2007-03-01 00:00:00