Age at First Rotavirus Vaccination and Risk of Intussusception in Infants: A Public Health Modeling Analysis.

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：:Intranasal corticosteroids and intranasal antihistamines are efficacious topical therapies in the treatment of allergic rhinitis. This review addresses their relative roles in the management of this disease, focusing on their safety and tolerability profiles. The intranasal route of administration delivers drug direct...

journal_title：Drug safety

authors： Salib RJ,Howarth PH

更新日期：2003-01-01 00:00:00

abstract：INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT...

journal_title：Drug safety

authors： Ding X,Li Q,Li P,Zhang T,Cui B,Ji G,Lu X,Zhang F

更新日期：2019-07-01 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：: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：BACKGROUND:Fatal venous thromboembolism (VTE) is a rare complication of combined oral contraceptive (COC) treatment. This study aims to determine incidences of fatal VTE in relation to the type of COC and the percentage of cases reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). A further aim i...

journal_title：Drug safety

authors： Hedenmalm K,Samuelsson E

更新日期：2005-01-01 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：:In the US, adverse drug reactions (ADRs) rank between the fourth to sixth leading cause of death, ahead of pneumonia and diabetes mellitus. An important reason for the high incidence of serious and fatal ADRs is that the existing drug development paradigms do not generate adequate information on the mechanistic source...

journal_title：Drug safety

authors： Ozdemir V,Shear NH,Kalow W

更新日期：2001-01-01 00:00:00

abstract：BACKGROUND:Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombi...

journal_title：Drug safety

authors： Hamilton T,Menter A,Caro I,Compton P,Sobell J,Papp KA

更新日期：2008-01-01 00:00:00

abstract：:Most antiviral drugs are nucleoside analogues with potential teratogenic, embryotoxic, carcinogenic and antiproliferative activities. They must be administered with caution during pregnancy, because some are known teratogens (e.g. amantadine) and a similar propensity cannot be entirely excluded for others (e.g. aciclo...

journal_title：Drug safety

authors： Morris DJ

更新日期：1994-04-01 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：: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：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：:Several anticancer drugs have been associated with cardiac toxicity, especially the anthracyclines and trastuzumab. The pathogenesis of anthracycline-associated toxicity has been well described, whereas the mechanism of trastuzumab-associated toxicity is unknown. Although routine cardiac imaging studies (e.g. echocard...

journal_title：Drug safety

authors： Sparano JA,Brown DL,Wolff AC

更新日期：2002-01-01 00:00:00

abstract：INTRODUCTION:Previously, an app has been developed for healthcare professionals (HCPs) and patients to report adverse drug reactions (ADRs) to national medicines agencies and to receive drug safety information. OBJECTIVE:This study aimed to assess (1) European HCPs' and patients' interest in an app for this two-way ri...

journal_title：Drug safety

authors： de Vries ST,Denig P,Lasheras Ruiz C,Houÿez F,Wong L,Sutcliffe A,Mol PGM,IMI Web-RADR Work Package 3b Consortium.

更新日期：2018-07-01 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：: ...

journal_title：Drug safety

authors： Simoons M,Seldenrijk A,Mulder H,van Roon E,Bakker R,Ruhé H

更新日期：2018-12-01 00:00:00

abstract：BACKGROUND:The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and the...

journal_title：Drug safety

authors： Sevene E,Mariano A,Mehta U,Machai M,Dodoo A,Vilardell D,Patel S,Barnes K,Carné X

更新日期：2008-01-01 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：:In general, the selective estrogen receptor modulators (SERMs) currently indicated for the treatment and prevention of breast cancer, i.e. tamoxifen and toremifene, are fairly well tolerated. However, tamoxifen has been shown to induce hepatocellular carcinomas in rats, but not in humans, and can increase the risk of ...

journal_title：Drug safety

authors： Curtis MG

更新日期：2001-01-01 00:00:00

abstract：INTRODUCTION:Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacist...

journal_title：Drug safety

authors： Barnes J,Butler R

更新日期：2020-11-01 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：OBJECTIVES:A prescription event monitoring (PEM) postmarketing surveillance study was carried out to examine the safety of zafirlukast as used in general practice in England. METHODS:Exposure data were obtained from the first National Health Service (NHS) prescription dispensed for patients whose prescription details ...

journal_title：Drug safety

authors： Twaites BR,Wilton LV,Shakir SA

更新日期：2007-01-01 00:00:00

abstract：:Although inhaled and intranasal corticosteroids are first-line therapy for asthma and allergic rhinitis, there has recently been an increasing awareness of their propensity to produce systemic adverse effects. The availability of more potent and lipophilic corticosteroids and new chlorofluorocarbon (CFC)-free formulat...

journal_title：Drug safety

authors： Lipworth BJ,Jackson CM

更新日期：2000-07-01 00:00:00

abstract：:The development of in vitro models is advancing rapidly, with the application of cell culture methods as an alternative to animals in toxicological screening; non-cellular systems are also being used. Any screening test, whether for detecting irritants, carcinogens or teratogens should be well validated against known ...

journal_title：Drug safety

authors： Anderson D

更新日期：1990-01-01 00:00:00

abstract：:Cholinesterase inhibitors are currently the most established treatment strategy in Alzheimer's disease. The treatment effect appears mainly to be symptomatic. Effects on progression of the disease following long term treatment, and possible neuroprotective effects, have been investigated. Delay until nursing home plac...

journal_title：Drug safety

authors： Nordberg A,Svensson AL

更新日期：1998-12-01 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：: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：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：BACKGROUND:Potential severe liver injury is identified in clinical trials by ALT >3 × upper limits of normal (ULN) and total bilirubin >2 × ULN, and termed 'Hy's Law' by the US FDA. However, there is limited evidence or validation of these thresholds in clinical trial populations. Using liver chemistry data from clinic...

journal_title：Drug safety

authors： Lin X,Parks D,Painter J,Hunt CM,Stirnadel-Farrant HA,Cheng J,Menius A,Lee K

更新日期：2012-10-01 00:00:00