Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK.

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：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：INTRODUCTION:The case-population approach compares exposure among cases to that of their source population. By using aggregated data to estimate the denominator, this approach can provide a real-time estimate of an association that could be particularly valuable to explore urgent vaccine safety concerns and to generate...

journal_title：Drug safety

authors： Théophile H,Moore N,Robinson P,Bégaud B,Pariente A

更新日期：2016-12-01 00:00:00

abstract：:Stroke is a very common medical emergency that, until recently, had no specific treatment. Following the results of several major trials (including 2 'mega-trials'), aspirin (acetylsalicylic acid) can be recommended for the majority of patients with acute ischaemic stroke. While the benefit of aspirin is only modest, ...

journal_title：Drug safety

authors： Lindley RI

更新日期：1998-11-01 00:00:00

abstract：:The main goal of pharmacological research in the field of topical corticosteroids (TCs) is to dissociate efficacy and adverse effects as much as possible. The optimal use of TCs, i.e. the careful evaluation of the benefit/risk ratio, depends on: (i) the chemical structure of the TC; (ii) the type of vehicle; (iii) the...

journal_title：Drug safety

authors： Mori M,Pimpinelli N,Giannotti B

更新日期：1994-05-01 00:00:00

abstract：INTRODUCTION:Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. OBJECTIVES:The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and altern...

journal_title：Drug safety

authors： Webster RK,Weinman J,Rubin GJ

更新日期：2017-08-01 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：: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:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

journal_title：Drug safety

authors： Ramaswamy K,Kozma CM,Nasrallah H

更新日期：2007-01-01 00:00:00

abstract：INTRODUCTION:Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current pra...

journal_title：Drug safety

authors： Webster RK,Rubin GJ

更新日期：2020-10-01 00:00:00

abstract：:Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. ...

journal_title：Drug safety

authors： Patras de Campaigno E,Kebir I,Montastruc JL,Rueter M,Maret D,Lapeyre-Mestre M,Sallerin B,Despas F

更新日期：2018-08-01 00:00:00

abstract：INTRODUCTION:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....

journal_title：Drug safety

authors： Schutte T,Tichelaar J,Reumerman MO,van Eekeren R,Rolfes L,van Puijenbroek EP,Richir MC,van Agtmael MA

更新日期：2017-05-01 00:00:00

abstract：INTRODUCTION:Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence...

journal_title：Drug safety

authors： Belleudi V,Trotta F,Addis A,Ingrasciotta Y,Ientile V,Tari M,Gini R,Pastorello M,Scondotto S,Cananzi P,Traversa G,Davoli M,Trifirò G,Italian Biosimilar Network (ItaBioNet).

更新日期：2019-12-01 00:00:00

abstract：:The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy...

journal_title：Drug safety

authors： Yamaoka K

更新日期：2016-09-01 00:00:00

abstract：BACKGROUND AND PURPOSE:Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed in the elderly due to a more favorable risk profile than other antidepressants (ADs). However, SSRIs are associated with an increased risk of gastrointestinal bleeding, while evidence on the risk of hemorrhagic stroke (HS) ...

journal_title：Drug safety

authors： Schäfer W,Princk C,Kollhorst B,Schink T

更新日期：2019-09-01 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：:In the original publication of the article, the trend line for non-EEA cases in figure 4 is incorrect. In this correction, the original Fig. 4 (Fig. 1) and the correct Fig. 4 (Fig. 2) are published. ...

journal_title：Drug safety

authors： Newbould V,Le Meur S,Goedecke T,Kurz X

更新日期：2018-12-01 00:00:00

abstract：:Drug-induced torsade de pointes is a rare life-threatening adverse drug reaction (ADR) which is strongly influenced by gender. Drugs that prolong cardiac repolarisation include antiarrhythmics, gastrokinetics, antipsychotics, antihistamines and antibacterials. Such drugs share the potential to block cardiac voltage-ga...

journal_title：Drug safety

authors： Drici MD,Clément N

更新日期：2001-01-01 00:00:00

abstract：:Cutaneous adverse drug reactions are a frequent occurrence and have been reported in more than 2% of hospitalised patients. Among the most commonly involved drugs are sulphonamides, penicillins, anticonvulsants and non-steroidal anti-inflammatory drugs. Two groups of mechanisms are involved in the pathogenesis of drug...

journal_title：Drug safety

authors： Raviglione MC,Pablos-Mendez A,Battan R

更新日期：1990-01-01 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：:Intranasal corticosteroids and intranasal antihistamines are efficacious topical therapies in the treatment of allergic rhinitis. This review addresses their relative roles in the management of this disease, focusing on their safety and tolerability profiles. The intranasal route of administration delivers drug direct...

journal_title：Drug safety

authors： Salib RJ,Howarth PH

更新日期：2003-01-01 00:00:00

abstract：BACKGROUND:Over-the-counter analgesics (OTCAs), principally paracetamol (acetaminophen)-containing compounds and NSAIDs, are commonly used medications. Guidelines for the use of these agents in patients with chronic liver disease (CLD) are not available, despite the possibility that such patients may be more susceptibl...

journal_title：Drug safety

authors： Rossi S,Assis DN,Awsare M,Brunner M,Skole K,Rai J,Andrel J,Herrine SK,Reddy RK,Navarro VJ

更新日期：2008-01-01 00:00:00

abstract：INTRODUCTION:Gastric acid-related symptoms are highly prevalent in the general population (21-40%), and more than 11% of individuals use medication for the treatment of these symptoms. The uptake of micronutrients is dependent on the gastrointestinal potential of hydrogen (pH). OBJECTIVE:We hypothesized that medicatio...

journal_title：Drug safety

authors： Huijgen NA,Goijen HJ,Twigt JM,Mulders AG,Lindemans J,Dohle GR,Laven JS,Steegers-Theunissen RP

更新日期：2017-03-01 00:00:00

abstract：BACKGROUND AND OBJECTIVE:Many drugs that are used to treat children are either not licensed for use in paediatric patients (unlicensed) or prescribed outside the terms of the product licence (off label). The incidence of adverse drug reactions (ADRs) associated with the use of such drugs is yet to be established. This ...

journal_title：Drug safety

authors： Neubert A,Dormann H,Weiss J,Egger T,Criegee-Rieck M,Rascher W,Brune K,Hinz B

更新日期：2004-01-01 00:00:00

abstract：:In general, the selective estrogen receptor modulators (SERMs) currently indicated for the treatment and prevention of breast cancer, i.e. tamoxifen and toremifene, are fairly well tolerated. However, tamoxifen has been shown to induce hepatocellular carcinomas in rats, but not in humans, and can increase the risk of ...

journal_title：Drug safety

authors： Curtis MG

更新日期：2001-01-01 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：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：:Methylphenidate is the most widely use psychotropic medication in children in the US. It is both well tolerated and efficacious in the treatment of attention deficit hyperactivity disorder, and is associated with few serious adverse effects. However, the abuse of methylphenidate for the purpose of experiencing a 'high...

journal_title：Drug safety

authors： Rappley MD

更新日期：1997-09-01 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：:Most antiviral drugs are nucleoside analogues with potential teratogenic, embryotoxic, carcinogenic and antiproliferative activities. They must be administered with caution during pregnancy, because some are known teratogens (e.g. amantadine) and a similar propensity cannot be entirely excluded for others (e.g. aciclo...

journal_title：Drug safety

authors： Morris DJ

更新日期：1994-04-01 00:00:00