All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study.

abstract：BACKGROUND:Examination of clinical data routinely recorded in general practice provides significant opportunities for identifying and quantifying medicine-related adverse events not captured by spontaneous adverse reaction reporting systems. Robust pharmacovigilance methods for detecting and monitoring adverse events d...

journal_title：Drug safety

authors： Tomlin A,Reith D,Dovey S,Tilyard M

更新日期：2012-09-01 00:00:00

abstract：:Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Include...

journal_title：Drug safety

authors： Bouvy JC,De Bruin ML,Koopmanschap MA

更新日期：2015-05-01 00:00:00

abstract：BACKGROUND AND OBJECTIVE:Rosuvastatin is a lipid-lowering drug, the newest of a class of drugs called HMG-CoA reductase inhibitors, or 'statins', launched in the UK in March 2003. Our objective was to monitor the post-marketing safety of this drug, prescribed in primary care in England, using prescription-event monitor...

journal_title：Drug safety

authors： Kasliwal R,Wilton LV,Cornelius V,Aurich-Barrera B,Shakir SA

更新日期：2007-01-01 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：:Postoperative nausea and vomiting (PONV) is an age-old problem; more so since the blooming of ambulatory or day surgery centres within the last 2 decades. The aetiology of PONV is multifactorial. The incidence of PONV is usually higher in women and children than in men. PONV not only causes patient discomfort, anxiety...

journal_title：Drug safety

authors： Sung YF

更新日期：1996-03-01 00:00:00

abstract：:Linezolid is an oxazolidinone, a new class of antibacterial with a unique mechanism of action, namely inhibition of the formation of a functional 70S initiation complex in the 50S bacterial ribosomal subunit. Linezolid is highly active against multidrug-resistant Gram-positive cocci, including meticillin-resistant Sta...

journal_title：Drug safety

authors： Falagas ME,Vardakas KZ

更新日期：2008-01-01 00:00:00

abstract：INTRODUCTION:Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication e...

journal_title：Drug safety

authors： Schipperus M,Kaiafa G,Taylor L,Wetten S,Kreuzbauer G,Boshier A,Seesaghur A

更新日期：2019-01-01 00:00:00

abstract：:The electrocardiographic effects of ebastine and its active metabolite, carebastine, have been studied alone and in relevant drug-interaction studies in various patient populations. The overall cardiac tolerability of ebastine is excellent. In ebastine dose-ranging studies in adults and children, there were no meaning...

journal_title：Drug safety

authors： Moss AJ,Morganroth J

更新日期：1999-01-01 00:00:00

abstract：:Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards...

journal_title：Drug safety

authors： De Backer TL,Vander Stichele RH,Van Bortel LM

更新日期：2009-01-01 00:00:00

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：OBJECTIVE:Minocycline is an antibacterial drug used in the treatment of acne. Concern has been expressed over the possibility of severe adverse reactions to minocycline, including hepatitis. This study set out to identify and characterise reported cases of hepatotoxicity associated with the use of minocycline. METHODS...

journal_title：Drug safety

authors： Lawrenson RA,Seaman HE,Sundström A,Williams TJ,Farmer RD

更新日期：2000-10-01 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:Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. OBJECTIVE:The aim of the study was to characterize ADRs reported to the WHO-ADR database, ...

journal_title：Drug safety

authors： Aagaard L,Strandell J,Melskens L,Petersen PS,Holme Hansen E

更新日期：2012-12-01 00:00:00

abstract：:Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is struct...

journal_title：Drug safety

authors： Adlan AM,Lip GY

更新日期：2013-02-01 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：BACKGROUND:Several efforts are under way to develop and test methods for prospective drug safety monitoring using large, electronic claims databases. Prospective monitoring systems must incorporate signalling algorithms and techniques to mitigate confounding in order to minimize false positive and false negative signal...

journal_title：Drug safety

authors： Wahl PM,Gagne JJ,Wasser TE,Eisenberg DF,Rodgers JK,Daniel GW,Wilson M,Schneeweiss S,Rassen JA,Patrick AR,Avorn J,Bohn RL

更新日期：2012-05-01 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：:Blinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-n...

journal_title：Drug safety

authors： Stein A,Franklin JL,Chia VM,Arrindell D,Kormany W,Wright J,Parson M,Amouzadeh HR,Choudhry J,Joseph G

更新日期：2019-05-01 00:00:00

abstract：INTRODUCTION:Evaluation of risk minimization (RM) actions is an emerging area of regulatory science, often without tools to rapidly and systematically assess their effectiveness. PURPOSE:The aim of this study was to evaluate whether chronographs, typically used for rapid signal detection in observational longitudinal ...

journal_title：Drug safety

authors： Sobel RE,Blackwell W,Fram DM,Bate A

更新日期：2019-11-01 00:00:00

abstract：OBJECTIVES:Difficulty sleeping is a recognised tobacco withdrawal symptom, but sleep problems, like application site reactions, are commonly reported as adverse reactions to transdermal nicotine therapy. However, no studies have examined potential predictive factors associated with the occurrence of expected adverse ex...

journal_title：Drug safety

authors： Gourlay SG,Forbes A,Marriner T,McNeil JJ

更新日期：1999-06-01 00:00:00

abstract：OBJECTIVES:A prescription event monitoring (PEM) postmarketing surveillance study was carried out to examine the safety of zafirlukast as used in general practice in England. METHODS:Exposure data were obtained from the first National Health Service (NHS) prescription dispensed for patients whose prescription details ...

journal_title：Drug safety

authors： Twaites BR,Wilton LV,Shakir SA

更新日期：2007-01-01 00:00:00

abstract：:Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses...

journal_title：Drug safety

authors： Roughead EE,Pratt NL

更新日期：2015-12-01 00:00:00

abstract：BACKGROUND:Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death. METHOD:The UK General Pract...

journal_title：Drug safety

authors： McCarthy S,Cranswick N,Potts L,Taylor E,Wong IC

更新日期：2009-01-01 00:00:00

abstract：:It is a major clinical and public health problem that there is no clear strategy as to how we best make use of information obtained when pregnant women take drugs. For this reason, some pregnant women are not treated as they should be and some are given drugs they should not use. We suggest a monitoring system that co...

journal_title：Drug safety

authors： Olsen J,Czeizel A,Sørensen HT,Nielsen GL,de Jong van den Berg LT,Irgens LM,Olesen C,Pedersen L,Larsen H,Lie RT,de Vries CS,Bergman U

更新日期：2002-01-01 00:00:00

abstract：:The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize scientific evidence more efficiently. This discovery and synthesis process would be greatly accelerated through access to a common framework that brings all relevant information sources together within a standardized structure. ...

journal_title：Drug safety

authors： Boyce RD,Ryan PB,Norén GN,Schuemie MJ,Reich C,Duke J,Tatonetti NP,Trifirò G,Harpaz R,Overhage JM,Hartzema AG,Khayter M,Voss EA,Lambert CG,Huser V,Dumontier M

更新日期：2014-08-01 00:00:00

abstract：BACKGROUND:Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. OBJECTIVE:The aim of the study was to explore the...

journal_title：Drug safety

authors： Pariente A,Avillach P,Salvo F,Thiessard F,Miremont-Salamé G,Fourrier-Reglat A,Haramburu F,Bégaud B,Moore N,Association Française des Centres Régionaux de Pharmacovigilance (CRPV).

更新日期：2012-10-01 00:00:00

abstract：:The treatment of Lennox-Gastaut syndrome has been improved for some patients by the introduction of adjunctive therapy with newer anticonvulsants such as lamotrigine and topiramate and the availability of vagal nerve stimulation and the re-emergence of the use of the ketogenic diet in recent years. The place of standa...

journal_title：Drug safety

authors： Schmidt D,Bourgeois B

更新日期：2000-06-01 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：:The introduction of MedDRA, the Medical Dictionary for Regulatory Activities, as a standardised terminology may have a major impact on the performance of risk management. Thus, MedDRA is likely to have an important effect on the analysis of clinical trial safety data. Review of the most commonly used terms in clinical...

journal_title：Drug safety

authors： Brown EG

更新日期：2004-01-01 00:00:00

abstract：BACKGROUND:Researchers using observational data to understand drug effects must make a number of analytic design choices that suit the characteristics of the data and the subject of the study. Review of the published literature suggests that there is a lack of consistency even when addressing the same research question...

journal_title：Drug safety

authors： Stang PE,Ryan PB,Overhage JM,Schuemie MJ,Hartzema AG,Welebob E

更新日期：2013-10-01 00:00:00