Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrénées region (PharmacoMIP) network 2-year pilot study.

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:Controversy exists about an association between angiotensin-converting-enzyme inhibitors (ACEIs), angiotensin-receptor blockers (ARBs), and thiazides (TZs) and the risk of malignant melanoma (MM), and non-melanoma skin cancer-basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). OBJECTIVE:The aim ...

journal_title：Drug safety

authors： Nardone B,Majewski S,Kim AS,Kiguradze T,Martinez-Escala EM,Friedland R,Amin A,Laumann AE,Edwards BJ,Rademaker AW,Martini MC,West DP

更新日期：2017-03-01 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：: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：:Epilepsy is one of the most common neurological disorders. Even though existing antiepileptic drugs can render 80% of newly diagnosed patients seizure free, a significant number of patients have chronic intractable epilepsy causing disability with considerable socioeconomic implications. There is, therefore, a need fo...

journal_title：Drug safety

authors： Patsalos PN,Sander JW

更新日期：1994-07-01 00:00:00

abstract：INTRODUCTION AND OBJECTIVE:Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is well established, wh...

journal_title：Drug safety

authors： Klein K,Scholl JH,Vermeer NS,Broekmans AW,Van Puijenbroek EP,De Bruin ML,Stolk P

更新日期：2016-02-01 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：: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：:Epidural analgesia for caesarean section is increasingly used and is gradually replacing general anaesthesia. Hypotension is one of the main risks: preloading of the maternal circulation is used to prevent maternal hypotension and its consequences. For this, various colloid and crystalloid solutions are used. We repor...

journal_title：Drug safety

authors： Barbier P,Jonville AP,Autret E,Coureau C

更新日期：1992-01-01 00:00:00

abstract：INTRODUCTION:The prevalence of polymorphisms among the metabolising enzymes and pharmacodynamic receptors relevant for the thiazolidinediones differs by ethnic group, a factor that may modify risk of adverse drug events. OBJECTIVE:The aim of the study was to determine if the risk of oedema or heart failure associated ...

journal_title：Drug safety

authors： Roughead EE,Chan EW,Choi NK,Kimura M,Kimura T,Kubota K,Lai EC,Man KK,Nguyen TA,Ooba N,Park BJ,Sato T,Shin JY,Wang T,Griffiths J,Wong IC,Yang YH,Pratt NL

更新日期：2015-09-01 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：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：:Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proac...

journal_title：Drug safety

authors： Hartford CG,Petchel KS,Mickail H,Perez-Gutthann S,McHale M,Grana JM,Marquez P

更新日期：2006-01-01 00:00:00

abstract：:The clinician prescribing beta-blockers for his or her patients is faced with an often difficult situation. There are many beta-blockers, each with its own pharmacological profile. Patients are often taking multiple medications, thus increasing the risk of both anticipated and unexpected drug interactions. Reports of ...

journal_title：Drug safety

authors： Blaufarb I,Pfeifer TM,Frishman WH

更新日期：1995-12-01 00:00:00

abstract：:The mitochondrial respiratory chain (MRC) and ATP synthase (complex V) play an essential role in cellular energy production by the process of oxidative phosphorylation. In addition to inborn errors of metabolism, as well as secondary causes from disease pathophysiology, an impairment of oxidative phosphorylation can r...

journal_title：Drug safety

authors： Hargreaves IP,Al Shahrani M,Wainwright L,Heales SJ

更新日期：2016-07-01 00:00:00

abstract：BACKGROUND AND OBJECTIVE:Many drugs that are used to treat children are either not licensed for use in paediatric patients (unlicensed) or prescribed outside the terms of the product licence (off label). The incidence of adverse drug reactions (ADRs) associated with the use of such drugs is yet to be established. This ...

journal_title：Drug safety

authors： Neubert A,Dormann H,Weiss J,Egger T,Criegee-Rieck M,Rascher W,Brune K,Hinz B

更新日期：2004-01-01 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：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：: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：:Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...

journal_title：Drug safety

authors： Burgess E,Muruve D

更新日期：1992-07-01 00:00:00

abstract：BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...

journal_title：Drug safety

authors： Layton D,Souverein PC,Heerdink ER,Shakir SA,Egberts AC

更新日期：2008-01-01 00:00:00

abstract：:Since 2008, the direct-acting oral anticoagulants (DOACs) have expanded the therapeutic options of cardiovascular diseases with recognized clinical and epidemiological impact, such as non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE), and also in the preventive setting of orthopedic surgical pat...

journal_title：Drug safety

authors： Raschi E,Bianchin M,Ageno W,De Ponti R,De Ponti F

更新日期：2016-12-01 00:00:00

abstract：:Complex interactions exist amongst the various components of the neuroendocrine system in order to maintain homeostasis, energy balance and reproductive function. These components include the hypothalamus-pituitary- adrenal and -gonadal axes, the renin-angiotensin-aldosterone system, the sympathetic nervous system and...

journal_title：Drug safety

authors： Ma RC,Kong AP,Chan N,Tong PC,Chan JC

更新日期：2007-01-01 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：: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：BACKGROUND:Medication-related adverse events (MRAEs) form a large proportion of all adverse events in hospitalized patients and are associated with considerable preventable harm. Detailed information on harm related to drugs administered during hospitalization is scarce. Knowledge of the nature and preventability of MR...

journal_title：Drug safety

authors： Hoonhout LH,de Bruijne MC,Wagner C,Asscheman H,van der Wal G,van Tulder MW

更新日期：2010-10-01 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：:With the introduction of several new anticonvulsant drugs into clinical practice in recent years, renewed attention has been paid to treatment-emergent effects, especially behavioural syndromes. In this review, the more severe psychiatric syndromes that may be associated with anticonvulsants are discussed, especially ...

journal_title：Drug safety

authors： Trimble MR

更新日期：1996-09-01 00:00:00

abstract：INTRODUCTION:Evaluation of risk minimization (RM) actions is an emerging area of regulatory science, often without tools to rapidly and systematically assess their effectiveness. PURPOSE:The aim of this study was to evaluate whether chronographs, typically used for rapid signal detection in observational longitudinal ...

journal_title：Drug safety

authors： Sobel RE,Blackwell W,Fram DM,Bate A

更新日期：2019-11-01 00:00:00

abstract：:Clinical and pathophysiological differences between Japanese and Caucasian patients are observed in many aspects of heart disease. Indeed, data derived from studies in one population cannot be automatically extrapolated to the other. The therapeutic goal of heart failure has recently been aimed at improving mortality ...

journal_title：Drug safety

authors： Sasayama S

更新日期：2004-01-01 00:00:00