Empirical performance of LGPS and LEOPARD: lessons for developing a risk identification and analysis system.

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：INTRODUCTION:Gastric acid-related symptoms are highly prevalent in the general population (21-40%), and more than 11% of individuals use medication for the treatment of these symptoms. The uptake of micronutrients is dependent on the gastrointestinal potential of hydrogen (pH). OBJECTIVE:We hypothesized that medicatio...

journal_title：Drug safety

authors： Huijgen NA,Goijen HJ,Twigt JM,Mulders AG,Lindemans J,Dohle GR,Laven JS,Steegers-Theunissen RP

更新日期：2017-03-01 00:00:00

abstract：:Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of certain forms of cancers, raising hopes for many patients with otherwise unresponsive tumours. While these agents are generally well tolerated, clinical experience with them has highlighted their unexpected association with serious toxic effects on...

journal_title：Drug safety

authors： Shah DR,Shah RR,Morganroth J

更新日期：2013-06-01 00:00:00

abstract：:Lipodystrophy complications, including lipoatrophy (pathological fat loss) and metabolic complications, have emerged as important long-term toxicities associated with antiretroviral therapy in the current era. The wealth of data that has accumulated over the past 6 years has now clarified the contribution of specific ...

journal_title：Drug safety

authors： Nolan D

更新日期：2005-01-01 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：:Boxed warnings-also known as "black box" warnings-can be a powerful tool in communicating drug risks to physicians and patients. The overall number of boxed warnings has grown in recent years as the US Food and Drug Administration (FDA) has approved more drugs on the basis of limited pre-marketing information and as n...

journal_title：Drug safety

authors： Yeh JS,Sarpatwari A,Kesselheim AS

更新日期：2016-08-01 00:00:00

abstract：:Impulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The ...

journal_title：Drug safety

authors： Grall-Bronnec M,Victorri-Vigneau C,Donnio Y,Leboucher J,Rousselet M,Thiabaud E,Zreika N,Derkinderen P,Challet-Bouju G

更新日期：2018-01-01 00:00:00

abstract：:Adoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] eng...

journal_title：Drug safety

authors： Wolf B,Zimmermann S,Arber C,Irving M,Trueb L,Coukos G

更新日期：2019-02-01 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：INTRODUCTION:Adverse drug reactions (ADRs) are unintended reactions caused by a drug or combination of drugs taken by a patient. The current safety surveillance system relies on spontaneous reporting systems (SRSs) and more recently on observational health data; however, ADR detection may be delayed and lack geographic...

journal_title：Drug safety

authors： Li Y,Jimeno Yepes A,Xiao C

更新日期：2020-09-01 00:00:00

abstract：:The prevalence and incidence of adverse drug interactions involving nonsteroidal anti-inflammatory drugs (NSAIDs) remains unknown. To identify those proposed drug interactions of greatest clinical significance, it is appropriate to focus on interactions between commonly used and/or commonly coprescribed drugs, interac...

journal_title：Drug safety

authors： Johnson AG,Seideman P,Day RO

更新日期：1993-02-01 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

abstract：INTRODUCTION:As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE:Our objective w...

journal_title：Drug safety

authors： Baan EJ,de Smet VA,Hoeve CE,Pacurariu AC,Sturkenboom MCJM,de Jongste JC,Janssens HM,Verhamme KMC

更新日期：2020-01-01 00:00:00

abstract：:NSAIDs are widely used to treat pain and inflammation in osteoarthritis. Their use in this indication is generally intermittent and fluctuates with the intensity of the disease. Nonetheless, success of the therapy is frequently limited by injury to the gastrointestinal mucosa and complications such as bleeding, ulcera...

journal_title：Drug safety

authors： Schmidt H,Woodcock BG,Geisslinger G

更新日期：2004-01-01 00:00:00

abstract：:Drug safety is not a matter for healthcare professionals alone. Patients are also involved, at three different levels: (i) in the behaviours patients adopt to reduce the adverse effects of the drugs; (ii) in regard to what some doctors say to their patients about drug risks; and (iii) in what the pharmaceutical indust...

journal_title：Drug safety

authors： Fainzang S

更新日期：2010-08-01 00:00:00

abstract：:The aim of this review is to analyse and summarise the literature data about the incidence of weight gain in patients exposed to atypical antipsychotics during long-term (>or=1 year) treatment regimens. Despite the clinical relevance of the topic, the vast majority of reviewed studies showed methodological limitations...

journal_title：Drug safety

authors： Gentile S

更新日期：2006-01-01 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：:Monobactams and carbapenems are 2 classes of beta-lactam antibiotics that were introduced in the 1980s. This review considers the monobactam aztreonam and the carbapenems imipenem and meropenem. Imipenem is administered together with cilastatin, which inhibits the enzymatic breakdown of imipenem in the kidney. The ant...

journal_title：Drug safety

authors： Alván G,Nord CE

更新日期：1995-05-01 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：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：: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：BACKGROUND AND PURPOSE:Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed in the elderly due to a more favorable risk profile than other antidepressants (ADs). However, SSRIs are associated with an increased risk of gastrointestinal bleeding, while evidence on the risk of hemorrhagic stroke (HS) ...

journal_title：Drug safety

authors： Schäfer W,Princk C,Kollhorst B,Schink T

更新日期：2019-09-01 00:00:00

abstract：:Since the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heteroge...

journal_title：Drug safety

authors： Förster M,Küry P,Aktas O,Warnke C,Havla J,Hohlfeld R,Mares J,Hartung HP,Kremer D

更新日期：2019-05-01 00:00:00

abstract：BACKGROUND:The detection of new drug safety signals is of growing importance with ever more new drugs becoming available and exposure to medicines increasing. The task of evaluating information relating to safety lies with national agencies and, for international data, with the World Health Organization Programme for I...

journal_title：Drug safety

authors： Lindquist M,Ståhl M,Bate A,Edwards IR,Meyboom RH

更新日期：2000-12-01 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 US FDA has issued safety alerts and required manufacturers of leukotriene-modifying agents (LTMAs), including montelukast, zafirlukast and zileuton, to include suicide and neuropsychiatric events as a precaution in the drug label. This paper reviews the existing evidence on the potential association between the LT...

journal_title：Drug safety

authors： Schumock GT,Lee TA,Joo MJ,Valuck RJ,Stayner LT,Gibbons RD

更新日期：2011-07-01 00:00:00

abstract：:Propofol (2, 6-diisopropylphenol) is a potent intravenous hypnotic agent that is widely used in adults and children for sedation and the induction and maintenance of anaesthesia. Propofol has gained popularity for its rapid onset and rapid recovery even after prolonged use, and for the neuroprotection conferred. Howev...

journal_title：Drug safety

authors： Fodale V,La Monaca E

更新日期：2008-01-01 00:00:00

abstract：:The occurrence of breast cancer during pregnancy is a rare clinical situation. However, if it is diagnosed, a multidisciplinary approach involving an obstetrician, a medical oncologist and a surgeon is needed. In this situation, breast cancer should be treated according to the same principles applied in nonpregnant pa...

journal_title：Drug safety

authors： Espié M,Cuvier C

更新日期：1998-02-01 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：:Many drug products contain excipients which perform important functions in terms of stability, solubility and identification. Excipients should not be considered as inactive ingredients, as they have been associated with a wide range of adverse reactions in some individuals. Monitoring for excipient toxicity is import...

journal_title：Drug safety

authors： Scott AW

更新日期：1990-01-01 00:00:00