Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System.

abstract：:Current key challenges and controversies encountered in the identification of potentially hepatotoxic drugs and the assessment of drug-induced liver injury (DILI) are covered in this article. There is substantial debate over the classification of DILI itself, including the definition and validity of terms such as 'int...

journal_title：Drug safety

authors： Corsini A,Ganey P,Ju C,Kaplowitz N,Pessayre D,Roth R,Watkins PB,Albassam M,Liu B,Stancic S,Suter L,Bortolini M

更新日期：2012-12-01 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：: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：: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：:The new generation fluoroquinolones -- sparfloxacin, levofloxacin, grepafloxacin and trovafloxacin -- have been designed to respond to the clinical need for extended antimicrobial cover in the face of increasing global microbial resistance. Their main focus is in the treatment of respiratory infections, particularly t...

journal_title：Drug safety

authors： Lode H

更新日期：1999-08-01 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：:Insomnia is a heterogeneous, highly prevalent condition that is associated with a high level of psychiatric, physical, social and economic morbidity. The treatment of insomnia involves pharmacological and non-pharmacological interventions. The mainstay of pharmacological treatment of insomnia has been the benzodiazepi...

journal_title：Drug safety

authors： Barbera J,Shapiro C

更新日期：2005-01-01 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：:Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. ...

journal_title：Drug safety

authors： Patras de Campaigno E,Kebir I,Montastruc JL,Rueter M,Maret D,Lapeyre-Mestre M,Sallerin B,Despas F

更新日期：2018-08-01 00:00:00

abstract：:Current antiretroviral therapy has lead to longer survival in patients infected with HIV, but it is also associated with new and important problems. Body fat redistribution and metabolic abnormalities, the so-called lipodystrophy syndrome, are among the most prevalent and worrisome ones. While an increasing number of ...

journal_title：Drug safety

authors： Martínez E,Garcia-Viejo MA,Blanch L,Gatell JM

更新日期：2001-01-01 00:00:00

abstract：:Pharmacotherapy in pregnant women is often necessary to treat chronic or relapsing depression or anxiety disorders. Studies that have evaluated the safety of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy have not shown an enhanced risk of major congenital malformations and these results may have c...

journal_title：Drug safety

authors： Nordeng H,Spigset O

更新日期：2005-07-01 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：BACKGROUND:For many regularly used drugs, evidence for safe use in pregnancy has not been established. Despite this, international studies have identified high levels of drug prescribing among pregnant women. OBJECTIVE:To investigate the patterns of prescribing of drugs to women who gave birth in Tayside, Scotland, in...

journal_title：Drug safety

authors： Irvine L,Flynn RW,Libby G,Crombie IK,Evans JM

更新日期：2010-07-01 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：:The treatment of type 2 diabetes mellitus remains controversial. Since most patients are overweight or obese, regimens based on dietary modification and increased physical exercise are logical and safe treatment approaches. However, the long term impact of these interventions is frequently disappointing and pharmacoth...

journal_title：Drug safety

authors： Evans A,Krentz AJ

更新日期：1999-07-01 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：: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：INTRODUCTION:An often key component to coordinating surveillance activities across distributed networks is the design and implementation of a common data model (CDM). The purpose of this study was to evaluate two drug safety surveillance CDMs from an ecosystem perspective to better understand how differences in CDMs an...

journal_title：Drug safety

authors： Xu Y,Zhou X,Suehs BT,Hartzema AG,Kahn MG,Moride Y,Sauer BC,Liu Q,Moll K,Pasquale MK,Nair VP,Bate A

更新日期：2015-08-01 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：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：:The treatment of Lennox-Gastaut syndrome has been improved for some patients by the introduction of adjunctive therapy with newer anticonvulsants such as lamotrigine and topiramate and the availability of vagal nerve stimulation and the re-emergence of the use of the ketogenic diet in recent years. The place of standa...

journal_title：Drug safety

authors： Schmidt D,Bourgeois B

更新日期：2000-06-01 00:00:00

abstract：BACKGROUND:There are no head-to-head randomized controlled trials comparing different direct oral anticoagulants (DOACs). Thus, we systematically reviewed and meta-analyzed observational studies assessing the comparative effectiveness and safety of DOACs for stroke prevention in patients with atrial fibrillation (AF). ...

journal_title：Drug safety

authors： Douros A,Durand M,Doyle CM,Yoon S,Reynier P,Filion KB

更新日期：2019-10-01 00:00:00

abstract：:The electrocardiographic effects of ebastine and its active metabolite, carebastine, have been studied alone and in relevant drug-interaction studies in various patient populations. The overall cardiac tolerability of ebastine is excellent. In ebastine dose-ranging studies in adults and children, there were no meaning...

journal_title：Drug safety

authors： Moss AJ,Morganroth J

更新日期：1999-01-01 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 risks and adverse effects of the low dose, new generation progestogen combined oral contraceptives (COCs) are much lower than original studies involving pills containing 50 micrograms estrogen. The main effects are those on the cardiovascular system, lipid and glucose metabolism and cancer. Any effect of the COC o...

journal_title：Drug safety

authors： Bagshaw S

更新日期：1995-02-01 00:00:00

abstract：OBJECTIVES:Difficulty sleeping is a recognised tobacco withdrawal symptom, but sleep problems, like application site reactions, are commonly reported as adverse reactions to transdermal nicotine therapy. However, no studies have examined potential predictive factors associated with the occurrence of expected adverse ex...

journal_title：Drug safety

authors： Gourlay SG,Forbes A,Marriner T,McNeil JJ

更新日期：1999-06-01 00:00:00

abstract：:Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...

journal_title：Drug safety

authors： Inokuma Y

更新日期：2017-06-01 00:00:00

abstract：:The biochemistry of vitamin K metabolism and the role of vitamin K-dependent gamma-carboxylation of the vitamin K-dependent coagulation factors are now well understood. Likewise, there is a clear understanding of the role of oral anticoagulants in the inhibition of these coagulation factors. However, the effect of ora...

journal_title：Drug safety

authors： Pineo GF,Hull RD

更新日期：1993-10-01 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：:Thallium poisoning seldom occurs in Spain. This article reports 5 cases of thallium poisoning, of which 4 of the patients belonged to the same family. The cases occurred in or near Granada between 1985 and 1987. The symptoms were initially gastrointestinal (vomiting, abdominal pain, gastrointestinal haemorrhage, etc.)...

journal_title：Drug safety

authors： Villanueva E,Hernandez-Cueto C,Lachica E,Rodrigo MD,Ramos V

更新日期：1990-09-01 00:00:00