Topical corticosteroids and unwanted local effects. Improving the benefit/risk ratio.

abstract：:This 'Erice Call for Change' is a report from a group of experts, patients and patient representatives who met in Erice in September 2019 following previous similar meetings after the original Erice Declaration (1996). The aim of the meeting was to discuss the challenge of causal complexity and individual variation in...

journal_title：Drug safety

authors： Rocca E,Anjum RL

更新日期：2020-06-01 00:00:00

abstract：INTRODUCTION:There are few studies assessing how data on adverse drug events from consumers on social media compare with other sources. AIM:The aim of this study was to assess the consistency of adverse event data of statin medications from social media as compared with other sources. METHODS:We collected data on the...

journal_title：Drug safety

authors： Golder S,Smith K,O'Connor K,Gross R,Hennessy S,Gonzalez-Hernandez G

更新日期：2021-02-01 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：:Drug eruptions are among the most common adverse drug reactions, affecting approximately 3% of hospitalised patients. Although the rate of severe cutaneous adverse reactions to medications is low, these reactions can affect anyone who takes medication, and can result in death or disability. Two general patterns can be...

journal_title：Drug safety

authors： Valeyrie-Allanore L,Sassolas B,Roujeau JC

更新日期：2007-01-01 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：:Several anticancer drugs have been associated with cardiac toxicity, especially the anthracyclines and trastuzumab. The pathogenesis of anthracycline-associated toxicity has been well described, whereas the mechanism of trastuzumab-associated toxicity is unknown. Although routine cardiac imaging studies (e.g. echocard...

journal_title：Drug safety

authors： Sparano JA,Brown DL,Wolff AC

更新日期：2002-01-01 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：: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：: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：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：: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：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：INTRODUCTION:Adverse event (AE) under-reporting has been a recurrent issue raised during health authorities Good Clinical Practices (GCP) inspections and audits. Moreover, safety under-reporting poses a risk to patient safety and data integrity. The current clinical Quality Assurance (QA) practices used to detect AE un...

journal_title：Drug safety

authors： Ménard T,Barmaz Y,Koneswarakantha B,Bowling R,Popko L

更新日期：2019-09-01 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：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

abstract：INTRODUCTION:Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacist...

journal_title：Drug safety

authors： Barnes J,Butler R

更新日期：2020-11-01 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：:Clinical and pathophysiological differences between Japanese and Caucasian patients are observed in many aspects of heart disease. Indeed, data derived from studies in one population cannot be automatically extrapolated to the other. The therapeutic goal of heart failure has recently been aimed at improving mortality ...

journal_title：Drug safety

authors： Sasayama S

更新日期：2004-01-01 00:00:00

abstract：:Gastroesophageal reflux is one of the most common reasons for referrals to paediatricians or paediatric gastroenterologists. Gastric acid-buffering agents, mucosal surface barriers and gastric anti-secretory agents are the main groups of medications currently used for treating gastroesophageal reflux disease (GERD) in...

journal_title：Drug safety

authors： Kierkus J,Oracz G,Korczowski B,Szymanska E,Wiernicka A,Woynarowski M

更新日期：2014-05-01 00:00:00

abstract：INTRODUCTION:Pharmacovigilance includes analysis of large databases of information on drugs and events using algorithms that detect disproportional frequencies of associations. In order to test such algorithms, attempts have been made to provide canonical reference lists of so-called 'positive controls' and 'negative c...

journal_title：Drug safety

authors： Hauben M,Aronson JK,Ferner RE

更新日期：2016-05-01 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：: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：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：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：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：:As the variety and range of pharmaceutical agents available to the medical profession continues to expand, one unavoidable effect will be an increase in drug-induced disease, including cardiovascular disorders. However, given the high rates of cardiovascular disease and prevalence of recognised cardiovascular risk fac...

journal_title：Drug safety

authors： Murphy CA,Dargie HJ

更新日期：2007-01-01 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：:Anaemia is common in patients with haematological malignancy, occurring in the majority of patients with malignant disease who are treated with chemotherapy. Most patients will have their anaemia attributed to the cytokine-mediated anaemia of chronic disease. Many of these patients with anaemia will be symptomatic wit...

journal_title：Drug safety

authors： Littlewood TJ

更新日期：2002-01-01 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：:Epilepsy is one of the most common neurological disorders. Even though existing antiepileptic drugs can render 80% of newly diagnosed patients seizure free, a significant number of patients have chronic intractable epilepsy causing disability with considerable socioeconomic implications. There is, therefore, a need fo...

journal_title：Drug safety

authors： Patsalos PN,Sander JW

更新日期：1994-07-01 00:00:00