Improving safety reporting from randomised trials.

abstract：BACKGROUND:The availability of large-scale observational healthcare data allows for the active monitoring of safety of drugs, but research is needed to determine which statistical methods are best suited for this task. Recently, the Longitudinal Gamma Poisson Shrinker (LGPS) and Longitudinal Evaluation of Observational...

journal_title：Drug safety

authors： Schuemie MJ,Madigan D,Ryan PB

更新日期：2013-10-01 00:00:00

abstract：:Acute intoxication with inorganic fluoride disrupts numerous physiological systems. As a potent acid it acts corrosively on the skin and mucous membranes, producing severe burns. As the most electronegative element it tightly binds many cations essential to homeostasis, producing, for example, profound hypocalcaemia a...

journal_title：Drug safety

authors： McIvor ME

更新日期：1990-03-01 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：:A number of affluent countries are moving to eliminate thiomersal (thimerosal), an ethylmercury preservative, from vaccines as a precautionary measure because of concerns about the potential adverse effects of mercury in infants. The WHO advocates continued use of thiomersal-containing vaccines in developing countries...

journal_title：Drug safety

authors： Bigham M,Copes R

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：BACKGROUND:Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would m...

journal_title：Drug safety

authors： Anton C,Cox AR,Ferner RE

更新日期：2009-01-01 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：:The development of antiretroviral therapy (ART) has dramatically increased the lifespan of HIV patients but treatment is complicated by numerous adverse effects and toxicities. ART complications include neuropsychiatric, metabolic, gastrointestinal, cardiac, and numerous other toxicities, and clinicians often have to ...

journal_title：Drug safety

authors： Treisman GJ,Soudry O

更新日期：2016-10-01 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：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：:The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...

journal_title：Drug safety

authors： Bergvall T,Norén GN,Lindquist M

更新日期：2019-06-01 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: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：:While classifications into generations according to antimicrobial activity has helped clinicians incorporate the increasing number of cephalosporins into their pharmacological repertoire, adverse effects among the different agents fail to follow similar categories. In general, cephalosporins are fairly well tolerated ...

journal_title：Drug safety

authors： Thompson JW,Jacobs RF

更新日期：1993-08-01 00:00:00

abstract：OBJECTIVE:During proton pump inhibitor (PPI) use, in clinical trials, headache is one of the most frequently reported adverse events (frequency 1.3 to 8.8%), while results of one observational study indicate that headache is the fifth most frequently reported adverse event (incidence densities 2.5 to 4.6 per 1000 patie...

journal_title：Drug safety

authors： Claessens AA,Heerdink ER,van Eijk JT,Lamers CB,Leufkens HG

更新日期：2002-01-01 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：:The available antihyperlipidaemic drugs are generally safe and effective, and major systemic adverse effects are uncommon. However, because of their complex mechanisms of action, careful monitoring is required to identify and correct potential drug interactions. Bile acid sequestrants are the most difficult of these a...

journal_title：Drug safety

authors： Farmer JA,Gotto AM Jr

更新日期：1994-11-01 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：:Phytoestrogens, plant chemicals classified as isoflavones, coumestans and lignans, display estrogen-like activity because of their structural similarity to human estrogens and exhibit high affinity binding for the estrogen receptor beta. They are common components of food items such as grains, beans, fruits and nuts. ...

journal_title：Drug safety

authors： Sirtori CR

更新日期：2001-01-01 00:00:00

abstract：:Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...

journal_title：Drug safety

authors： Shah RR

更新日期：2019-02-01 00:00:00

abstract：:Blinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-n...

journal_title：Drug safety

authors： Stein A,Franklin JL,Chia VM,Arrindell D,Kormany W,Wright J,Parson M,Amouzadeh HR,Choudhry J,Joseph G

更新日期：2019-05-01 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：: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：BACKGROUND:Screening large databases of spontaneous case reports of possible adverse drug reactions (ADRs) is an established method of identifying hitherto unknown adverse effects of medicinal products; however, there is a lack of consensus concerning the value of formal statistical screening procedures in guiding such...

journal_title：Drug safety

authors： Alvarez Y,Hidalgo A,Maignen F,Slattery J

更新日期：2010-06-01 00:00:00

abstract：:The increasing incidence of Crohn's disease has lead to speculation about changes in exposures to environmental or infectious agents. Considerable attention has focused on the role of measles infection and/or vaccination in the pathogenesis of Crohn's disease and ulcerative colitis. Current evidence regarding the asso...

journal_title：Drug safety

authors： Davis RL,Bohlke K

更新日期：2001-01-01 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：BACKGROUND:At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of...

journal_title：Drug safety

authors： Mol PG,Arnardottir AH,Motola D,Vrijlandt PJ,Duijnhoven RG,Haaijer-Ruskamp FM,de Graeff PA,Denig P,Straus SM

更新日期：2013-11-01 00:00:00

abstract：:Older people in the UK receive a disproportionate amount of medication. They comprise 18% of the population but receive 45% of all prescription items. Not surprisingly they experience drug-related illnesses - in 1980, 1 in 10 admissions to acute geriatric units were wholly or partly due to adverse drug reactions. Drug...

journal_title：Drug safety

authors： Denham MJ,Barnett NL

更新日期：1998-10-01 00:00:00

abstract：:The non-vitamin K antagonist oral anticoagulants (NOACs) are used for thromboembolic prophylaxis of patients with atrial fibrillation and in the treatment as well as secondary prophylaxis of patients with venous thromboembolism. Even though NOACs have a better safety profile than vitamin K antagonists (VKAs), there wi...

journal_title：Drug safety

authors： Husted S,Verheugt FW,Comuth WJ

更新日期：2016-01-01 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