Intentional rechallenge: does the benefit outweigh the risk?

abstract：:Cytokines are now commonly used in the treatment of many conditions, especially cancer, haematological malignancies and chronic viral hepatitis. With some of these cytokines, clinical induction and/or exacerbation of autoimmune manifestations have been observed. This has been the case with interferon-alpha and interfe...

journal_title：Drug safety

authors： Miossec P

更新日期：1997-08-01 00:00:00

abstract：:The prevalence of pain is high in multimorbid patients and they can experience a multitude of painful conditions. The changes in physiology and homeostasis associated with multimorbidity and increasing age and the immature metabolism of neonates all increase the risk of toxicity from analgesics. Altered pharmacokineti...

journal_title：Drug safety

authors： Wilder-Smith CH

更新日期：1998-06-01 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：:Cholinesterase inhibitors are currently the most established treatment strategy in Alzheimer's disease. The treatment effect appears mainly to be symptomatic. Effects on progression of the disease following long term treatment, and possible neuroprotective effects, have been investigated. Delay until nursing home plac...

journal_title：Drug safety

authors： Nordberg A,Svensson AL

更新日期：1998-12-01 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：: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：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：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：:Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancom...

journal_title：Drug safety

authors： Mohammadi M,Jahangard-Rafsanjani Z,Sarayani A,Hadjibabaei M,Taghizadeh-Ghehi M

更新日期：2017-01-01 00:00:00

abstract：:Transdermal devices are now marketed for the delivery of systemic medication through the skin. Advantages associated with transdermal drug delivery include avoidance of first-pass metabolism and improved patient compliance. Drugs currently available by this route include scopolamine (hyoscine), nitroglycerin (glyceryl...

journal_title：Drug safety

authors： Carmichael AJ

更新日期：1994-02-01 00:00:00

abstract：:Randomised clinical trials offer a unique opportunity for capturing safety information under a controlled setting that minimises biases in the comparison of different therapeutic options. Nevertheless, empirical evidence across diverse medical fields suggests that the reporting of safety information in clinical trials...

journal_title：Drug safety

authors： Ioannidis JP,Lau J

更新日期：2002-01-01 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 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：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：:Drug-induced QT interval prolongation is now a major concern in safety pharmacology. Regulatory authorities such as the US FDA and the European Medicines Agency require in vitro testing of all drug candidates against the potential risk for QT interval prolongation prior to clinical trials. Common in vitro methods incl...

journal_title：Drug safety

authors： Meyer T,Boven KH,Günther E,Fejtl M

更新日期：2004-01-01 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：: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：:Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety...

journal_title：Drug safety

authors： Huysentruyt K,Kjoersvik O,Dobracki P,Savage E,Mishalov E,Cherry M,Leonard E,Taylor R,Patel B,Abatemarco D

更新日期：2021-02-01 00:00:00

abstract：: ...

journal_title：Drug safety

authors： Simoons M,Seldenrijk A,Mulder H,van Roon E,Bakker R,Ruhé H

更新日期：2018-12-01 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：:Complex interactions exist amongst the various components of the neuroendocrine system in order to maintain homeostasis, energy balance and reproductive function. These components include the hypothalamus-pituitary- adrenal and -gonadal axes, the renin-angiotensin-aldosterone system, the sympathetic nervous system and...

journal_title：Drug safety

authors： Ma RC,Kong AP,Chan N,Tong PC,Chan JC

更新日期：2007-01-01 00:00:00

abstract：:The use of triple regimens, often called highly active antiretroviral therapy (HAART), generally involving 2 nucleoside analogues and an HIV protease inhibitor, have been endorsed as the standard of care for persons with HIV initiating therapy by a number of sets of international guidelines. The widespread availabilit...

journal_title：Drug safety

authors： Moyle GJ,Gazzard BG

更新日期：1999-04-01 00:00:00

abstract：BACKGROUND:Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis r...

journal_title：Drug safety

authors： Fischer MA,Lilly CM,Churchill WW,Baden LR,Avorn J

更新日期：2004-01-01 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：:With the introduction of several new anticonvulsant drugs into clinical practice in recent years, renewed attention has been paid to treatment-emergent effects, especially behavioural syndromes. In this review, the more severe psychiatric syndromes that may be associated with anticonvulsants are discussed, especially ...

journal_title：Drug safety

authors： Trimble MR

更新日期：1996-09-01 00:00:00

abstract：:There are 2 isoenzymes of cyclo-oxygenase (COX). There is a constitutive enzyme COX-1 which has a wide tissue distribution. In addition there is an inducible enzyme COX-2 which has a restricted tissue distribution. The inducible enzyme COX-2 is responsible for the generation of prostaglandins at sites of tissue inflam...

journal_title：Drug safety

authors： Richardson C,Emery P

更新日期：1996-10-01 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：: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：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: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