Assessment of Self-Administration of Romiplostim in Patients with Immune Thrombocytopenic Purpura after Receipt of Home Administration Training Materials: a Cross-Sectional Study.

abstract：:Adverse drug effects are manifold and heterogenous. Many situations may hamper the signalling (i.e. the detection of early warning signs) of adverse effects and new signals often differ from previous experiences. Signals have qualitative and quantitative aspects. Different categories of adverse effects need different ...

journal_title：Drug safety

authors： Meyboom RH,Egberts AC,Edwards IR,Hekster YA,de Koning FH,Gribnau FW

更新日期：1997-06-01 00:00:00

abstract：:Absolute and functional iron deficiency is the most common cause of epoetin (recombinant human erythropoietin) hyporesponsiveness in renal failure patients. Diagnostic procedures for determining iron deficiency include measurement of serum iron levels, serum ferritin levels, saturation of transferrin and percentage of...

journal_title：Drug safety

authors： Sunder-Plassmann G,Hörl WH

更新日期：1997-10-01 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：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：: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：INTRODUCTION:Theoretically, benzodiazepines (BZDs) can narrow the iridocorneal angle and induce acute angle-closure glaucoma (AACG). However, little evidence exists regarding this association. OBJECTIVE:The objective of this study was to assess whether the use of BZDs is associated with the risk of AACG. METHODS:We c...

journal_title：Drug safety

authors： Kim WJ,Li J,Oh IS,Song I,Lee E,Namkoong K,Shin JY

更新日期：2020-06-01 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：:Cirrhosis encompasses a range of pathophysiological changes that may alter drug disposition. Drugs that are dependent primarily on the liver for their systemic clearance are more likely to be subject to reduced elimination and subsequent accumulation. Drug accumulation may lead to excessive plasma drug concentrations ...

journal_title：Drug safety

authors： Westphal JF,Brogard JM

更新日期：1997-07-01 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：BACKGROUND:Acute liver failure is idiopathic and drug-related in, respectively, around 50 and 15 % of children. Population-based, epidemiologic data about the pattern of disease manifestation and incidence of less severe acute liver injury, either idiopathic or potentially drug-attributed are limited in children and ad...

journal_title：Drug safety

authors： Ferrajolo C,Verhamme KM,Trifirò G,'t Jong GW,Giaquinto C,Picelli G,Oteri A,de Bie S,Valkhoff VE,Schuemie MJ,Mazzaglia G,Cricelli C,Rossi F,Capuano A,Sturkenboom MC

更新日期：2013-10-01 00:00:00

abstract：BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...

journal_title：Drug safety

authors： de Vries HS,van Oijen MG,de Jong DJ

更新日期：2008-01-01 00:00:00

abstract：BACKGROUND:It has been shown that the abrupt cessation of treatment with beta-adrenoceptor antagonists (beta-blockers) increases the risk of myocardial infarction in patients with hypertension. As beta-blockers differ in their pharmacokinetic and pharmacodynamic properties, this risk of discontinuation might also diffe...

journal_title：Drug safety

authors： Teichert M,de Smet PA,Hofman A,Witteman JC,Stricker BH

更新日期：2007-01-01 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：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：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：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：:Recent evidence from animal studies has raised the possibility that immunisation by vaccines can influence the pathogenesis of type I (insulin-dependent) diabetes mellitus. In non-obese diabetic mice and biobreeding rats, complete Freund's adjuvant and bacillus Calmette-Guérin (BCG) vaccine have successfully been used...

journal_title：Drug safety

authors： Hiltunen M,Lönnrot M,Hyöty H

更新日期：1999-03-01 00:00:00

abstract：INTRODUCTION:One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to pai...

journal_title：Drug safety

authors： Min J,Osborne V,Kowalski A,Prosperi M

更新日期：2018-03-01 00:00:00

abstract：BACKGROUND:Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. OBJECTIVE:The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic prep...

journal_title：Drug safety

authors： Bar-Oz B,Weber-Schoendorfer C,Berlin M,Clementi M,Di Gianantonio E,de Vries L,De Santis M,Merlob P,Stahl B,Eleftheriou G,Maňáková E,Hubičková-Heringová L,Youngster I,Berkovitch M

更新日期：2012-07-01 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：: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：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：BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...

journal_title：Drug safety

authors： Bailey S,Singh A,Azadian R,Huber P,Blum M

更新日期：2010-02-01 00:00:00

abstract：: ...

journal_title：Drug safety

authors： Kawada T

更新日期：2018-06-01 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 August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the un...

journal_title：Drug safety

authors： Baksh SN,Gellad WF,Alexander GC

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：: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：BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...

journal_title：Drug safety

authors： Johannesen L,Garnett C,Malik M

更新日期：2014-03-01 00:00:00

abstract：:An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. Since 1998, Bayesian Confidence Propagation Neural Network (BCPNN) data mining has been in routine use for screening of the WHO adverse reaction database, Vigibas...

journal_title：Drug safety

authors： Lindquist M

更新日期：2007-01-01 00:00:00