How Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial

Laine, Loren; Goldkind, Lawrence; Curtis, Sean; Connors, Laurine; Zhang, Yanqiong; Cannon, Christopher

doi:10.1038/ajg.2008.149

Cited by 109 publications

(59 citation statements)

References 14 publications

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“…Picture adapted from Roth and Ganey [2010] with references [Boelsterli, 2003;Franceschi et al 2000;Banks et al 1995;Rikans and Moore, 1988]. Therapeutic Advances in Drug Safety 1 (2) and resolve with cessation of therapy [Laine et al 2009]. Symptomatic reporting was the major cause for identification of injury while monitoring was responsible for only 18% of injury being identified [Banks et al 1995].…”

Section: Pharmacokinetic Changesmentioning

confidence: 99%

Drug-induced liver injury in older adults

Mitchell

Hilmer

2010

Therapeutic Advances in Drug Safety

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Drug-induced liver injury (DILI) is an important cause of hospitalisation and of medication deregistration. In old age, susceptibility to DILI is affected by changes in physiology and increased interindividual variability, compounded by an increased prevalence of disease and the frailty syndrome. While dose-related or predictable DILI reactions are often detected in preclinical trials, the occurrence of rare hypersensitivity or idiosyncratic reactions cannot be reliably predicted from preclinical studies or even by clinical trials. The limited participation of older adults in clinical trials means that the susceptibility of this population to DILI is largely unknown. Vigilance during clinical trials and postmarketing surveillance must be universally practised. A systematic approach should be taken to determine not only which medicines are hepatotoxic and should be removed from the market, but also the hepatotoxicity risks from marketed drugs to consumers with different characteristics, many of whom are older people.

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Section: Pharmacokinetic Changesmentioning

confidence: 99%

Drug-induced liver injury in older adults

Mitchell

Hilmer

2010

Therapeutic Advances in Drug Safety

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“…Causality assessment of ADRs may be undertaken by clinicians, academics, the pharmaceutical industry and regulators, and in different settings, including clinical trials. [188][189][190][191] At an individual level, health-care providers assess causality informally when dealing with ADRs in patients to make decisions regarding future therapy. Many regulatory authorities assess spontaneous ADR reports, 189,191 where causality assessment can help in signal detection and risk-benefit decisions regarding medicines, 192,193 using formal CATs to aid in this process.…”

Section: Introductionmentioning

confidence: 99%

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Smyth

Peak

Turner

et al. 2014

Programme Grants for Applied Research

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AimsTo comprehensively investigate the incidence, nature and risk factors of adverse drug reactions (ADRs) in a hospital-based population of children, with rigorous assessment of causality, severity and avoidability, and to assess the consequent impact on children and families. We aimed to improve the assessment of ADRs by development of new tools to assess causality and avoidability, and to minimise the impact on families by developing better strategies for communication.Review methodsTwo prospective observational studies, each over 1 year, were conducted to assess ADRs in children associated with admission to hospital, and those occurring in children who were in hospital for longer than 48 hours. We conducted a comprehensive systematic review of ADRs in children. We used the findings from these studies to develop and validate tools to assess causality and avoidability of ADRs, and conducted interviews with parents and children who had experienced ADRs, using these findings to develop a leaflet for parents to inform a communication strategy about ADRs.ResultsThe estimated incidence of ADRs detected in children on admission to hospital was 2.9% [95% confidence interval (CI) 2.5% to 3.3%]. Of the reactions, 22.1% (95% CI 17% to 28%) were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44 out of 249 (17.7%) of ADRs, the remainder originating from hospital. A total of 120 out of 249 (48.2%) reactions resulted from treatment for malignancies. Off-label and/or unlicensed (OLUL) medicines were more likely to be implicated in an ADR than authorised medicines [relative risk (RR) 1.67, 95% CI 1.38 to 2.02;p < 0.001]. When medicines used for the treatment of oncology patients were excluded, OLUL medicines were not more likely to be implicated in an ADR than authorised medicines (RR 1.03, 95% CI 0.72 to 1.48;p = 0.830). For children who had been in hospital for > 48 hours, the overall incidence of definite and probable ADRs based on all admissions was 15.9% (95% CI 15.0 to 16.8). Opiate analgesic drugs and drugs used in general anaesthesia (GA) accounted for > 50% of all drugs implicated in ADRs. The odds ratio of an OLUL drug being implicated in an ADR compared with an authorised drug was 2.25 (95% CI 1.95 to 2.59;p < 0.001). Risk factors identified were exposure to a GA, age, oncology treatment and number of medicines. The systematic review estimated that the incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children [pooled estimate of 2.9% (95% CI 2.6% to 3.1%)] and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. New tools to assess causality and avoidability of ADRs have been developed and validated. Many parents described being dissatisfied with clinician communication about ADRs, whereas parents of children with cancer emphasised confidence in clinician management of ADRs and the way clinicians communicated about medicines. The accounts of children and young people largely reflected parents’ accounts. Clinicians described using all of the features of communication that parents wanted to see, but made active decisions about when and what to communicate to families about suspected ADRs, which meant that communication may not always match families’ needs and expectations. We developed a leaflet to assist clinicians in communicating ADRs to parents.ConclusionThe Adverse Drug Reactions In Children (ADRIC) programme has provided the most comprehensive assessment, to date, of the size and nature of ADRs in children presenting to, and cared for in, hospital, and the outputs that have resulted will improve the management and understanding of ADRs in children and adults within the NHS. Recommendations for future research: assess the values that parents and children place on the use of different medicines and the risks that they will find acceptable within these contexts; focusing on high-risk drugs identified in ADRIC, determine the optimum drug dose for children through the development of a gold standard practice for the extrapolation of adult drug doses, alongside targeted pharmacokinetic/pharmacodynamic studies; assess the research and clinical applications of the Liverpool Causality Assessment Tool and the Liverpool Avoidability Assessment Tool; evaluate, in more detail, morbidities associated with anaesthesia and surgery in children, including follow-up in the community and in the home setting and an assessment of the most appropriate treatment regimens to prevent pain, vomiting and other postoperative complications; further evaluate strategies for communication with families, children and young people about ADRs; and quantify ADRs in other settings, for example critical care and neonatology.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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“…Достоинствами мелоксикама являются практически отсутствие гепатотоксического осложнения и редкое раз-витие аллергических реакций, что подтверждается дан-ными американских коллег [18,19].…”

Section: ревматологияunclassified

Reasonable Therapy of Pain Syndromes of Diseases of T H E Musculoskeletal System

Denisov¹

2017

Med. sov.

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Статья посвящена возможностям применения современных нестероидных противовоспалительных препаратов при забо-леваниях опорно-двигательного аппарата. Представлен обзор исследований клинической эффективности и безопасности мелоксикама у пациентов ревматологического профиля.Ключевые слова: остеоартроз, ревматоидный артрит, болевой синдром, нестероидные противовоспалительные препа-раты, мелоксикам. L.N. DENISOV, MD, Nasonova Research Institute of Reumatology, Moscow REASONABLE THERAPY OF PAIN SYNDROMES OF DISEASES OF THE MUSCULOSKELETAL SYSTEMThe article concentrates on the possibilities of using modern non-steroidal anti-inflammatory drugs to treat diseases of the musculoskeletal system. It presents the review of studies of clinical efficacy and safety of meloxicam in patients with rheumatologic profile.

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How Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial

Cited by 109 publications

References 14 publications

Drug-induced liver injury in older adults

Drug-induced liver injury in older adults

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Reasonable Therapy of Pain Syndromes of Diseases of T H E Musculoskeletal System

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