Risk perception and communication in sub-Saharan Africa.

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：: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：:In the US, adverse drug reactions (ADRs) rank between the fourth to sixth leading cause of death, ahead of pneumonia and diabetes mellitus. An important reason for the high incidence of serious and fatal ADRs is that the existing drug development paradigms do not generate adequate information on the mechanistic source...

journal_title：Drug safety

authors： Ozdemir V,Shear NH,Kalow W

更新日期：2001-01-01 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：: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：:Concomitant use of antacid preparations with other medications is common. The potential for antacid-drug interactions is dependent upon the chemistry and physical properties of the antacid preparation. The intragastric release of free aluminum and magnesium ions has potent effects on gastrointestinal function and on d...

journal_title：Drug safety

authors： Sadowski DC

更新日期：1994-12-01 00:00:00

abstract：:Although travellers' diarrhoea can sometimes be associated with postinfectious complications, the condition is typically self-limiting. The infectious-diarrhoea guidelines subcommittees of the Infectious Disease Society of America and the American College of Gastroenterology recommend empirical antibacterial therapy f...

journal_title：Drug safety

authors： Ericsson CD

更新日期：2006-01-01 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：INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT...

journal_title：Drug safety

authors： Ding X,Li Q,Li P,Zhang T,Cui B,Ji G,Lu X,Zhang F

更新日期：2019-07-01 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: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：INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...

journal_title：Drug safety

authors： Yung CF,Chong CY,Thoon KC

更新日期：2016-08-01 00:00:00

abstract：INTRODUCTION:The Bradford Hill criteria are a widely used, useful tool for the assessment of biomedical causation. We have examined their application to pharmacovigilance using the example of cisapride-induced QTc interval prolongation/arrhythmia. METHODS:A literature search was conducted using MEDLINE, EMBASE, Reacti...

journal_title：Drug safety

authors： Perrio M,Voss S,Shakir SA

更新日期：2007-01-01 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：: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：: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: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：:It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstra...

journal_title：Drug safety

authors： Hou Y,Li X,Wu G,Ye X

更新日期：2016-11-01 00:00:00

abstract：:Narcolepsy is a life-long central nervous system (CNS) syndrome characterised by excessive sleepiness, cataplexy, sleep paralysis, hypnagogic hallucinations and disturbed night-time sleep. Unsuccessfully treated narcolepsy confers increased risks on patients and on society due to the patient's increased chance of beco...

journal_title：Drug safety

authors： Mitler MM,Hayduk R

更新日期：2002-01-01 00:00:00

abstract：:Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed to women of child-bearing age. Three case series highlight the possibility of a link between NSAIDs and reversible infertility. The pharmacological target of NSAIDs is cyclo-oxygenase (COX), which catalyses the first rate-limiting step in the prod...

journal_title：Drug safety

authors： Stone S,Khamashta MA,Nelson-Piercy C

更新日期：2002-01-01 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：: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：:Although heart failure is predominantly caused by cardiovascular conditions such as hypertension, coronary heart disease and valvular heart disease, it can also be an adverse reaction induced by drug therapy. In addition, some drugs have the propensity to adversely affect haemodynamic mechanisms in patients with an al...

journal_title：Drug safety

authors： Slørdal L,Spigset O

更新日期：2006-01-01 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：:The complications of failure, neural injury and local anaesthetic toxicity are common to all regional anaesthesia techniques, and individual techniques are associated with specific complications. All potential candidates for regional anaesthesia should be thoroughly evaluated and informed of potential complications. I...

journal_title：Drug safety

authors： Faccenda KA,Finucane BT

更新日期：2001-01-01 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：:Several recent case control studies have shown an excess rate of venous thromboembolism in women using third generation progestogen-containing combined contraceptive pills compared to second generation combined contraceptive pills. This excess is about 1 in 10,000 women per year of use. It is likely that second and th...

journal_title：Drug safety

authors： Roke C

更新日期：1997-02-01 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：: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：: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