Use of triage strategies in the WHO signal-detection process.

abstract：BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

journal_title：Drug safety

authors： Brown BA,Torabi M

更新日期：2011-02-01 00:00:00

abstract：INTRODUCTION:Previously, an app has been developed for healthcare professionals (HCPs) and patients to report adverse drug reactions (ADRs) to national medicines agencies and to receive drug safety information. OBJECTIVE:This study aimed to assess (1) European HCPs' and patients' interest in an app for this two-way ri...

journal_title：Drug safety

authors： de Vries ST,Denig P,Lasheras Ruiz C,Houÿez F,Wong L,Sutcliffe A,Mol PGM,IMI Web-RADR Work Package 3b Consortium.

更新日期：2018-07-01 00:00:00

abstract：BACKGROUND:The detection of new drug safety signals is of growing importance with ever more new drugs becoming available and exposure to medicines increasing. The task of evaluating information relating to safety lies with national agencies and, for international data, with the World Health Organization Programme for I...

journal_title：Drug safety

authors： Lindquist M,Ståhl M,Bate A,Edwards IR,Meyboom RH

更新日期：2000-12-01 00:00:00

abstract：BACKGROUND:Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2 inhibitors where different do...

journal_title：Drug safety

authors： Stefansdottir G,De Bruin ML,Knol MJ,Grobbee DE,Leufkens HG

更新日期：2011-09-01 00:00:00

abstract：:Opioids have been accepted as appropriate treatment for acute and cancer pain, but their role in the management of chronic nonmalignant pain is the subject of much debate, mainly due to concerns about waning efficacy, the potential for neuropsychological impairment and the development of drug addiction. Controlled cli...

journal_title：Drug safety

authors： Bannwarth B

更新日期：1999-10-01 00:00:00

abstract：INTRODUCTION AND OBJECTIVE:Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is well established, wh...

journal_title：Drug safety

authors： Klein K,Scholl JH,Vermeer NS,Broekmans AW,Van Puijenbroek EP,De Bruin ML,Stolk P

更新日期：2016-02-01 00:00:00

abstract：:Betahistine is a structural analogue of histamine that is prescribed for the treatment of vestibular disorders such as Ménière's disease and the symptomatic treatment of vertigo. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. In this revi...

journal_title：Drug safety

authors： Jeck-Thole S,Wagner W

更新日期：2006-01-01 00:00:00

abstract：:Osteoporosis is a major public health problem occurring primarily among the postmenopausal population. Osteoporosis is a preventable disease, but despite several advances in its prevention, treatment of the established disease to date remains a major challenge to be managed by primary care physicians. Stabilisation of...

journal_title：Drug safety

authors： Gennari C,Nuti R,Agnusdei D,Camporeale A,Martini G

更新日期：1994-09-01 00:00:00

abstract：: ...

journal_title：Drug safety

authors： Simoons M,Seldenrijk A,Mulder H,van Roon E,Bakker R,Ruhé H

更新日期：2018-12-01 00:00:00

abstract：:The WHO World Alliance on Patient Safety is a new, all encompassing project to improve medical care. Individual patients are the focus and all countries are encouraged to develop systems in which medical error, therapeutic accidents and failures are minimised. The potential for adverse events is present at all levels ...

journal_title：Drug safety

authors： Edwards IR

更新日期：2005-01-01 00:00:00

abstract：:The last decade has seen an increase in the trend of HMG-CoA reductase inhibitor (statin) usage in the Western world, which does not come as a surprise noting that the latest American Heart Association heart and stroke statistics indicate an alarming prevalence of 80  million Americans (one in three) with one or more ...

journal_title：Drug safety

authors： Maggo SD,Kennedy MA,Clark DW

更新日期：2011-01-01 00:00:00

abstract：:Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be ...

journal_title：Drug safety

authors： Ralph Edwards I

更新日期：2017-05-01 00:00:00

abstract：:Orally administered levodopa remains the most effective symptomatic treatment for Parkinson's disease. The introduction of levodopa therapy is often delayed, however, because of the fear that it might be toxic for the remaining dopaminergic neurons, and thus accelerate the deterioration of the patient's condition. Evi...

journal_title：Drug safety

authors： Murer MG,Raisman-Vozari R,Gershanik O

更新日期：1999-11-01 00:00:00

abstract：BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...

journal_title：Drug safety

authors： Trenque T,Maura G,Herlem E,Vallet C,Sole E,Auriche P,Drame M

更新日期：2013-07-01 00:00:00

abstract：:Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety...

journal_title：Drug safety

authors： Huysentruyt K,Kjoersvik O,Dobracki P,Savage E,Mishalov E,Cherry M,Leonard E,Taylor R,Patel B,Abatemarco D

更新日期：2021-02-01 00:00:00

abstract：:Thallium poisoning seldom occurs in Spain. This article reports 5 cases of thallium poisoning, of which 4 of the patients belonged to the same family. The cases occurred in or near Granada between 1985 and 1987. The symptoms were initially gastrointestinal (vomiting, abdominal pain, gastrointestinal haemorrhage, etc.)...

journal_title：Drug safety

authors： Villanueva E,Hernandez-Cueto C,Lachica E,Rodrigo MD,Ramos V

更新日期：1990-09-01 00:00:00

abstract：:The development of in vitro models is advancing rapidly, with the application of cell culture methods as an alternative to animals in toxicological screening; non-cellular systems are also being used. Any screening test, whether for detecting irritants, carcinogens or teratogens should be well validated against known ...

journal_title：Drug safety

authors： Anderson D

更新日期：1990-01-01 00:00:00

abstract：BACKGROUND:Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis r...

journal_title：Drug safety

authors： Fischer MA,Lilly CM,Churchill WW,Baden LR,Avorn J

更新日期：2004-01-01 00:00:00

abstract：:A spectrum of adverse drug reactions that are caused by the combined action of drugs and viruses has been described: ampicillin rash in acute infectious mononucleosis; Reye's syndrome; hypersensitivity reactions to sulphonamides in patients with HIV infection; drug-induced agranulocytosis; paracetamol (acetaminophen) ...

journal_title：Drug safety

authors： Levy M

更新日期：1997-01-01 00:00:00

abstract：BACKGROUND:In November 2009, a vaccination campaign against Influenza A (H1N1) was started in the Netherlands. The accelerated registration procedure of the vaccines used in this campaign and the use of these vaccines on a large scale indicated a need for real-time safety monitoring. OBJECTIVE:To describe the processi...

journal_title：Drug safety

authors： van Puijenbroek EP,Broos N,van Grootheest K

更新日期：2010-12-01 00:00:00

abstract：BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...

journal_title：Drug safety

authors： Johannesen L,Garnett C,Malik M

更新日期：2014-03-01 00:00:00

abstract：INTRODUCTION:The Bradford Hill criteria are a widely used, useful tool for the assessment of biomedical causation. We have examined their application to pharmacovigilance using the example of cisapride-induced QTc interval prolongation/arrhythmia. METHODS:A literature search was conducted using MEDLINE, EMBASE, Reacti...

journal_title：Drug safety

authors： Perrio M,Voss S,Shakir SA

更新日期：2007-01-01 00:00:00

abstract：:Zopiclone is a cyclopyrrolone hypnosedative that is chemically unrelated to the benzodiazepines but nevertheless potentiates gamma-aminobutyric acid-mediated neuronal inhibition, and has demonstrated proven efficacy and good tolerability in the treatment of insomnia over 15 years of use. Zopiclone is indicated for sho...

journal_title：Drug safety

authors： Hajak G

更新日期：1999-12-01 00:00:00

abstract：BACKGROUND:Hepatic dysfunction, manifested as liver enzyme elevations, occurs frequently in patients who are treated with interferon, however, data for patients with multiple sclerosis are limited. OBJECTIVE:To retrospectively assess the safety profile of interferon-beta-1a therapy with respect to liver function durin...

journal_title：Drug safety

authors： Francis GS,Grumser Y,Alteri E,Micaleff A,O'Brien F,Alsop J,Stam Moraga M,Kaplowitz N

更新日期：2003-01-01 00:00:00

abstract：BACKGROUND:An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospi...

journal_title：Drug safety

authors： Manzoli L,De Vito C,Marzuillo C,Boccia A,Villari P

更新日期：2012-03-01 00:00:00

abstract：INTRODUCTION:An often key component to coordinating surveillance activities across distributed networks is the design and implementation of a common data model (CDM). The purpose of this study was to evaluate two drug safety surveillance CDMs from an ecosystem perspective to better understand how differences in CDMs an...

journal_title：Drug safety

authors： Xu Y,Zhou X,Suehs BT,Hartzema AG,Kahn MG,Moride Y,Sauer BC,Liu Q,Moll K,Pasquale MK,Nair VP,Bate A

更新日期：2015-08-01 00:00:00

abstract：:Concomitant use of antacid preparations with other medications is common. The potential for antacid-drug interactions is dependent upon the chemistry and physical properties of the antacid preparation. The intragastric release of free aluminum and magnesium ions has potent effects on gastrointestinal function and on d...

journal_title：Drug safety

authors： Sadowski DC

更新日期：1994-12-01 00:00:00

abstract：BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...

journal_title：Drug safety

authors： de Vries HS,van Oijen MG,de Jong DJ

更新日期：2008-01-01 00:00:00

abstract：:Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...

journal_title：Drug safety

authors： Burgess E,Muruve D

更新日期：1992-07-01 00:00:00

abstract：BACKGROUND:A number of published studies compare adverse event rates for drugs on the basis of reports in the US FDA Adverse Event Reporting System (AERS). While the AERS data have the advantage of timely availability and a large capture population, the database is subject to many significant biases, and lacks complete...

journal_title：Drug safety

authors： Hochberg AM,Pearson RK,O'Hara DJ,Reisinger SJ

更新日期：2009-01-01 00:00:00