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：:Current key challenges and controversies encountered in the identification of potentially hepatotoxic drugs and the assessment of drug-induced liver injury (DILI) are covered in this article. There is substantial debate over the classification of DILI itself, including the definition and validity of terms such as 'int...

journal_title：Drug safety

authors： Corsini A,Ganey P,Ju C,Kaplowitz N,Pessayre D,Roth R,Watkins PB,Albassam M,Liu B,Stancic S,Suter L,Bortolini M

更新日期：2012-12-01 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：:In this narrative review, a brief summary of theoretical approaches to risk perception is followed by an analysis of some of the special factors influencing risk perception and risk communication in sub-Saharan Africa. Examples of recent and emergent local medicines and vaccine controversies in several countries are g...

journal_title：Drug safety

authors： Dodoo A,Hugman B

更新日期：2012-11-01 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：BACKGROUND:Potential severe liver injury is identified in clinical trials by ALT >3 × upper limits of normal (ULN) and total bilirubin >2 × ULN, and termed 'Hy's Law' by the US FDA. However, there is limited evidence or validation of these thresholds in clinical trial populations. Using liver chemistry data from clinic...

journal_title：Drug safety

authors： Lin X,Parks D,Painter J,Hunt CM,Stirnadel-Farrant HA,Cheng J,Menius A,Lee K

更新日期：2012-10-01 00:00:00

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：BACKGROUND:Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. OBJECTIVE:The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic prep...

journal_title：Drug safety

authors： Bar-Oz B,Weber-Schoendorfer C,Berlin M,Clementi M,Di Gianantonio E,de Vries L,De Santis M,Merlob P,Stahl B,Eleftheriou G,Maňáková E,Hubičková-Heringová L,Youngster I,Berkovitch M

更新日期：2012-07-01 00:00:00

abstract：BACKGROUND:Eosinophilic pneumonia (EP) has been noted in association with daptomycin use. The product labelling was recently updated to include EP in the Warnings and Precautions and Post-Marketing Experience sections. OBJECTIVE:The objective of this study was to analyse adverse event (AE) reports submitted to the US ...

journal_title：Drug safety

authors： Kim PW,Sorbello AF,Wassel RT,Pham TM,Tonning JM,Nambiar S

更新日期：2012-06-01 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：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：BACKGROUND:The case-population approach or population-based case-cohort approach is derived from the case-control design and consists of comparing past exposure to a given risk factor in subjects presenting a given disease or symptom (cases) with the exposure rate to this factor in the whole cohort or in the source pop...

journal_title：Drug safety

authors： Théophile H,Laporte JR,Moore N,Martin KL,Bégaud B

更新日期：2011-10-01 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：:The US FDA has issued safety alerts and required manufacturers of leukotriene-modifying agents (LTMAs), including montelukast, zafirlukast and zileuton, to include suicide and neuropsychiatric events as a precaution in the drug label. This paper reviews the existing evidence on the potential association between the LT...

journal_title：Drug safety

authors： Schumock GT,Lee TA,Joo MJ,Valuck RJ,Stayner LT,Gibbons RD

更新日期：2011-07-01 00:00:00

abstract：:Quinolones are a class of antibacterial agents for the treatment of several infectious diseases (e.g. urinary and respiratory tract infections). They are used worldwide due to their broad spectrum of activity, high bioavailability and good safety profile. The safety profile varies from quinolone to quinolone. The aim ...

journal_title：Drug safety

authors： Tomé AM,Filipe A

更新日期：2011-06-01 00:00:00

abstract：:The generation of autoantibodies and autoimmune diseases such as systemic lupus erythematosus has been associated with the use of certain drugs in humans. Early reports suggested that procainamide and hydralazine were associated with the highest risk of developing lupus, quinidine with a moderate risk and all other dr...

journal_title：Drug safety

authors： Chang C,Gershwin ME

更新日期：2011-05-01 00:00:00

abstract：:Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of...

journal_title：Drug safety

authors： Ebbers HC,Mantel-Teeuwisse AK,Moors EH,Schellekens H,Leufkens HG

更新日期：2011-04-01 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：: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：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:Pharmacists have an essential role in improving drug usage and preventing prescribing errors (PEs). PEs at the interface of care are common, sometimes leading to adverse drug events (ADEs). This was the first study to investigate, using a computerized search method, the number, types, severity, pharmacists' ...

journal_title：Drug safety

authors： Abdel-Qader DH,Harper L,Cantrill JA,Tully MP

更新日期：2010-11-01 00:00:00

abstract：BACKGROUND:Medication-related adverse events (MRAEs) form a large proportion of all adverse events in hospitalized patients and are associated with considerable preventable harm. Detailed information on harm related to drugs administered during hospitalization is scarce. Knowledge of the nature and preventability of MR...

journal_title：Drug safety

authors： Hoonhout LH,de Bruijne MC,Wagner C,Asscheman H,van der Wal G,van Tulder MW

更新日期：2010-10-01 00:00:00

abstract：BACKGROUND:In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. OBJECTIVE:To compare patient characteristics, suspected ...

journal_title：Drug safety

authors： McLernon DJ,Bond CM,Hannaford PC,Watson MC,Lee AJ,Hazell L,Avery A,Yellow Card Collaboration.

更新日期：2010-09-01 00:00:00

abstract：:Drug safety is not a matter for healthcare professionals alone. Patients are also involved, at three different levels: (i) in the behaviours patients adopt to reduce the adverse effects of the drugs; (ii) in regard to what some doctors say to their patients about drug risks; and (iii) in what the pharmaceutical indust...

journal_title：Drug safety

authors： Fainzang S

更新日期：2010-08-01 00:00:00

abstract：BACKGROUND:For many regularly used drugs, evidence for safe use in pregnancy has not been established. Despite this, international studies have identified high levels of drug prescribing among pregnant women. OBJECTIVE:To investigate the patterns of prescribing of drugs to women who gave birth in Tayside, Scotland, in...

journal_title：Drug safety

authors： Irvine L,Flynn RW,Libby G,Crombie IK,Evans JM

更新日期：2010-07-01 00:00:00

abstract：BACKGROUND:Screening large databases of spontaneous case reports of possible adverse drug reactions (ADRs) is an established method of identifying hitherto unknown adverse effects of medicinal products; however, there is a lack of consensus concerning the value of formal statistical screening procedures in guiding such...

journal_title：Drug safety

authors： Alvarez Y,Hidalgo A,Maignen F,Slattery J

更新日期：2010-06-01 00:00:00

abstract：BACKGROUND:Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. OBJECTIVE:The aim of this pilot study was to assess the e...

journal_title：Drug safety

authors： Gony M,Badie K,Sommet A,Jacquot J,Baudrin D,Gauthier P,Montastruc JL,Bagheri H

更新日期：2010-05-01 00:00:00

abstract：:After 2002, an association between stroke and antipsychotic use was reported in clinical trials and large database studies. This review considers previous quantitative reviews, newly published clinical trials, and recent observational cohort and case-control studies, and focuses on the clinical significance of the ris...

journal_title：Drug safety

authors： Sacchetti E,Turrina C,Valsecchi P

更新日期：2010-04-01 00:00:00

abstract：BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...

journal_title：Drug safety

authors： Bailey S,Singh A,Azadian R,Huber P,Blum M

更新日期：2010-02-01 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

abstract：BACKGROUND:While cases of amyotrophic lateral sclerosis (ALS) or ALS-like conditions have arisen in apparent association with HMG-CoA reductase inhibitors ('statins') and/or other lipid-lowering drugs (collectively termed 'statins' in this paper for brevity), additional information is needed to understand whether the c...

journal_title：Drug safety

authors： Golomb BA,Kwon EK,Koperski S,Evans MA

更新日期：2009-01-01 00:00:00

abstract：BACKGROUND:Pioglitazone is an antidiabetic drug that belongs to the thiazolidinedione (TZD) class of insulin-sensitizing agents. Adverse events to pioglitazone of potential severity are listed in the 'special warnings and special precautions for use' section of the pioglitazone summary of product characteristics (SPC),...

journal_title：Drug safety

authors： Fogg C,Kasliwal R,Shakir SA

更新日期：2009-01-01 00:00:00

abstract：BACKGROUND:Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would m...

journal_title：Drug safety

authors： Anton C,Cox AR,Ferner RE

更新日期：2009-01-01 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: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：BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...

journal_title：Drug safety

authors： Layton D,Souverein PC,Heerdink ER,Shakir SA,Egberts AC

更新日期：2008-01-01 00:00:00

abstract：:Propofol (2, 6-diisopropylphenol) is a potent intravenous hypnotic agent that is widely used in adults and children for sedation and the induction and maintenance of anaesthesia. Propofol has gained popularity for its rapid onset and rapid recovery even after prolonged use, and for the neuroprotection conferred. Howev...

journal_title：Drug safety

authors： Fodale V,La Monaca E

更新日期：2008-01-01 00:00:00

abstract：:Antiplatelet therapy is universally recommended for the prevention of recurrent events in patients with noncardioembolic ischaemic stroke or transient ischaemic attack (TIA), acute and chronic coronary artery disease, or peripheral arterial disease. However, choosing which antiplatelet agents to use in these situation...

journal_title：Drug safety

authors： Ruland S

更新日期：2008-01-01 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：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