Serious events with infliximab in patients with inflammatory bowel disease: a 9-year cohort study in the Netherlands.

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：INTRODUCTION:The prevalence of polymorphisms among the metabolising enzymes and pharmacodynamic receptors relevant for the thiazolidinediones differs by ethnic group, a factor that may modify risk of adverse drug events. OBJECTIVE:The aim of the study was to determine if the risk of oedema or heart failure associated ...

journal_title：Drug safety

authors： Roughead EE,Chan EW,Choi NK,Kimura M,Kimura T,Kubota K,Lai EC,Man KK,Nguyen TA,Ooba N,Park BJ,Sato T,Shin JY,Wang T,Griffiths J,Wong IC,Yang YH,Pratt NL

更新日期：2015-09-01 00:00:00

abstract：INTRODUCTION:New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received fr...

journal_title：Drug safety

authors： Banovac M,Candore G,Slattery J,Houÿez F,Haerry D,Genov G,Arlett P

更新日期：2017-07-01 00:00:00

abstract：:To estimate the frequency of adverse effects associated with the use of the transdermal nicotine patch, we abstracted and analysed data from 47 reports of 35 clinical trials. The meta-analysis presented here represents a synthesis of data from 41 groups of nicotine patch recipients totalling 5501 patients, and 33 grou...

journal_title：Drug safety

authors： Greenland S,Satterfield MH,Lanes SF

更新日期：1998-04-01 00:00:00

abstract：INTRODUCTION:Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE:We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS:...

journal_title：Drug safety

authors： Witges K,Shafer LA,Zarychanski R,Abou-Setta AM,Rabbani R,Dingwall O,Bernstein CN

更新日期：2020-12-01 00:00:00

abstract：:Data from basic science and clinical studies suggest that hydroxyurea (hydroxycarbamide)-based regimens are effective treatment options for patients with HIV at various stages of disease. In vitro studies of HIV-infected lymphocytes have shown that hydroxyurea: (i) inhibits viral DNA synthesis; (ii) synergistically in...

journal_title：Drug safety

authors： Lisziewicz J,Foli A,Wainberg M,Lori F

更新日期：2003-01-01 00:00:00

abstract：BACKGROUND:Drug-drug interactions (DDIs) are a well known risk factor for adverse drug reactions. HMG-CoA reductase inhibitors ('statins') are a cornerstone in the treatment of dyslipidaemia and patients with dyslipidaemia are concomitantly treated with a variety of additional drugs. Since DDIs are associated with adve...

journal_title：Drug safety

authors： Rätz Bravo AE,Tchambaz L,Krähenbühl-Melcher A,Hess L,Schlienger RG,Krähenbühl S

更新日期：2005-01-01 00:00:00

abstract：BACKGROUND:The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and the...

journal_title：Drug safety

authors： Sevene E,Mariano A,Mehta U,Machai M,Dodoo A,Vilardell D,Patel S,Barnes K,Carné X

更新日期：2008-01-01 00:00:00

abstract：BACKGROUND:Individual case reports of suspected harm from medicines are fundamental for signal detection in postmarketing surveillance. Their effective analysis requires reliable data and one challenge is report duplication. These are multiple unlinked records describing the same suspected adverse drug reaction (ADR) i...

journal_title：Drug safety

authors： Tregunno PM,Fink DB,Fernandez-Fernandez C,Lázaro-Bengoa E,Norén GN

更新日期：2014-04-01 00:00:00

abstract：:The term 'benefit-risk ratio' is often used as a general term linked to the use of a medicine. To balance risk and benefit is, however, a very complex exercise. For most medicines the benefits are limited to a few indications and for an individual patient there is usually only a single benefit sought but the potential...

journal_title：Drug safety

authors： Edwards R,Wiholm BE,Martinez C

更新日期：1996-07-01 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: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：:This review evaluates the benefits and potential health risks of the currently used drugs that are approved for the pharmacological treatment of obesity. Analysis of several long term clinical trials indicates that all of these drugs are efficient in reducing excess bodyweight, and that the majority of them allow the ...

journal_title：Drug safety

authors： Kolanowski J

更新日期：1999-02-01 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：: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：:Benzodiazepine drugs have been shown to suppress respiratory function in patients with chronic obstructive pulmonary disease (COPD). We designed a placebo-controlled crossover study to compare the effects of a new benzodiazepine, estazolam ('ProSom'), with those of flurazepam ('Dalmane') on cardiopulmonary function in...

journal_title：Drug safety

authors： Cohn MA,Morris DD,Juan D

更新日期：1992-03-01 00:00:00

abstract：:The prognosis is generally poor for patients who experience a cardiac arrest. The most common causes of sudden cardiac arrest are massive pulmonary embolism (PE) and acute myocardial infarction (MI). While thrombolysis is a first-line treatment option in massive PE and acute MI, cardiopulmonary resuscitation (CPR) has...

journal_title：Drug safety

authors： Spöhr F,Böttiger BW

更新日期：2003-01-01 00:00:00

abstract：:Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of certain forms of cancers, raising hopes for many patients with otherwise unresponsive tumours. While these agents are generally well tolerated, clinical experience with them has highlighted their unexpected association with serious toxic effects on...

journal_title：Drug safety

authors： Shah DR,Shah RR,Morganroth J

更新日期：2013-06-01 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：:Although inhaled and intranasal corticosteroids are first-line therapy for asthma and allergic rhinitis, there has recently been an increasing awareness of their propensity to produce systemic adverse effects. The availability of more potent and lipophilic corticosteroids and new chlorofluorocarbon (CFC)-free formulat...

journal_title：Drug safety

authors： Lipworth BJ,Jackson CM

更新日期：2000-07-01 00:00:00

abstract：:Impulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The ...

journal_title：Drug safety

authors： Grall-Bronnec M,Victorri-Vigneau C,Donnio Y,Leboucher J,Rousselet M,Thiabaud E,Zreika N,Derkinderen P,Challet-Bouju G

更新日期：2018-01-01 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：:Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescrib...

journal_title：Drug safety

authors： Stanulović V,Venegoni M,Edwards B

更新日期：2013-03-01 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：:Eosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including...

journal_title：Drug safety

authors： Jackson DJ,Korn S,Mathur SK,Barker P,Meka VG,Martin UJ,Zangrilli JG

更新日期：2020-05-01 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：:The present review outlines the clinical relevance of pharmacokinetic drug interactions within the HMG-CoA reductase inhibitor class. These interactions can result in markedly increased or decreased plasma concentrations of some drugs within this class. However, the relationship between altered plasma concentrations a...

journal_title：Drug safety

authors： Martin J,Krum H

更新日期：2003-01-01 00:00:00

abstract：:Iodinated contrast media (CM) are an integral part of modern diagnostic medicine. Although these agents are considered to be relatively safe, adverse effects in the form of allergy-like reactions occur in a significant number of exposed patients. These reactions may be divided into immediate and delayed responses. Imm...

journal_title：Drug safety

authors： Meth MJ,Maibach HI

更新日期：2006-01-01 00:00:00

abstract：:Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proac...

journal_title：Drug safety

authors： Hartford CG,Petchel KS,Mickail H,Perez-Gutthann S,McHale M,Grana JM,Marquez P

更新日期：2006-01-01 00:00:00

abstract：:Adverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at ...

journal_title：Drug safety

authors： van Eekeren R,Rolfes L,Koster AS,Magro L,Parthasarathi G,Al Ramimmy H,Schutte T,Tanaka D,van Puijenbroek E,Härmark L

更新日期：2018-11-01 00:00:00