Signal generation in the New Zealand Intensive Medicines Monitoring Programme: a combined clinical and statistical approach.

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：BACKGROUND:Case reports have related the use of HMG-CoA reductase inhibitors ('statins') to Parkinson's disease (PD). Paradoxically, however, statins may have potentially beneficial effects on neurodegenerative diseases due to their anti-inflammatory properties. OBJECTIVE:To explore the risk of the development of PD i...

journal_title：Drug safety

authors： Becker C,Jick SS,Meier CR

更新日期：2008-01-01 00:00:00

abstract：:The last decade has seen an increase in the trend of HMG-CoA reductase inhibitor (statin) usage in the Western world, which does not come as a surprise noting that the latest American Heart Association heart and stroke statistics indicate an alarming prevalence of 80  million Americans (one in three) with one or more ...

journal_title：Drug safety

authors： Maggo SD,Kennedy MA,Clark DW

更新日期：2011-01-01 00:00:00

abstract：OBJECTIVE:Minocycline is an antibacterial drug used in the treatment of acne. Concern has been expressed over the possibility of severe adverse reactions to minocycline, including hepatitis. This study set out to identify and characterise reported cases of hepatotoxicity associated with the use of minocycline. METHODS...

journal_title：Drug safety

authors： Lawrenson RA,Seaman HE,Sundström A,Williams TJ,Farmer RD

更新日期：2000-10-01 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：BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

journal_title：Drug safety

authors： Brown BA,Torabi M

更新日期：2011-02-01 00:00:00

abstract：:Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescrib...

journal_title：Drug safety

authors： Stanulović V,Venegoni M,Edwards B

更新日期：2013-03-01 00:00:00

abstract：:A spectrum of adverse drug reactions that are caused by the combined action of drugs and viruses has been described: ampicillin rash in acute infectious mononucleosis; Reye's syndrome; hypersensitivity reactions to sulphonamides in patients with HIV infection; drug-induced agranulocytosis; paracetamol (acetaminophen) ...

journal_title：Drug safety

authors： Levy M

更新日期：1997-01-01 00:00:00

abstract：:Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

journal_title：Drug safety

authors： Fox AM,Rieder MJ

更新日期：1993-07-01 00:00:00

abstract：:All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The eight available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure-lowering effects have been demonstrated whe...

journal_title：Drug safety

authors： Abraham HM,White CM,White WB

更新日期：2015-01-01 00:00:00

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：: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：:There are 2 isoenzymes of cyclo-oxygenase (COX). There is a constitutive enzyme COX-1 which has a wide tissue distribution. In addition there is an inducible enzyme COX-2 which has a restricted tissue distribution. The inducible enzyme COX-2 is responsible for the generation of prostaglandins at sites of tissue inflam...

journal_title：Drug safety

authors： Richardson C,Emery P

更新日期：1996-10-01 00:00:00

abstract：:Bisphosphonates are the primary pharmacological agents used for the management of osteoporosis and hypercalcaemia of malignant bone disease. The efficacy of these agents in these two conditions has been demonstrated in many well designed trials published over the past 2 decades. The variety of bisphosphonates currentl...

journal_title：Drug safety

authors： Bobba RS,Beattie K,Parkinson B,Kumbhare D,Adachi JD

更新日期：2006-01-01 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：:Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about s...

journal_title：Drug safety

authors： DeFrank JT,McCormack L,West SL,Lefebvre C,Burrus O

更新日期：2019-10-01 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：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：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：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：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：:Cutaneous adverse drug reactions are a frequent occurrence and have been reported in more than 2% of hospitalised patients. Among the most commonly involved drugs are sulphonamides, penicillins, anticonvulsants and non-steroidal anti-inflammatory drugs. Two groups of mechanisms are involved in the pathogenesis of drug...

journal_title：Drug safety

authors： Raviglione MC,Pablos-Mendez A,Battan R

更新日期：1990-01-01 00:00:00

abstract：:Betahistine is a structural analogue of histamine that is prescribed for the treatment of vestibular disorders such as Ménière's disease and the symptomatic treatment of vertigo. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. In this revi...

journal_title：Drug safety

authors： Jeck-Thole S,Wagner W

更新日期：2006-01-01 00:00:00

abstract：:Drug-induced torsade de pointes is a rare life-threatening adverse drug reaction (ADR) which is strongly influenced by gender. Drugs that prolong cardiac repolarisation include antiarrhythmics, gastrokinetics, antipsychotics, antihistamines and antibacterials. Such drugs share the potential to block cardiac voltage-ga...

journal_title：Drug safety

authors： Drici MD,Clément N

更新日期：2001-01-01 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：:There is clear experimental evidence that antibiotics increase the bioavailability of endotoxin from Gram-negative bacteria. In this review, data for 2 variables, level of endotoxin and level of bacteria, at the time point closest to 2 hours post-antibiotic exposure were abstracted as a change from baseline readings f...

journal_title：Drug safety

authors： Hurley JC

更新日期：1995-03-01 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: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：: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：: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