Adverse effects of coumarin anticoagulants.

abstract：BACKGROUND:An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospi...

journal_title：Drug safety

authors： Manzoli L,De Vito C,Marzuillo C,Boccia A,Villari P

更新日期：2012-03-01 00:00:00

abstract：BACKGROUND:Individual case reports of suspected harm from medicines are fundamental for signal detection in postmarketing surveillance. Their effective analysis requires reliable data and one challenge is report duplication. These are multiple unlinked records describing the same suspected adverse drug reaction (ADR) i...

journal_title：Drug safety

authors： Tregunno PM,Fink DB,Fernandez-Fernandez C,Lázaro-Bengoa E,Norén GN

更新日期：2014-04-01 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：:Severe skin adverse drug reactions can result in death, but the rate of such events is fortunately low. The incidences of Stevens-Johnson syndrome and toxic epidermal necrolysis range from 1.2 to 6 per million per year and 0.4 to 1.2 per million per year, respectively. Stevens-Johnson syndrome is fatal in about 5% and...

journal_title：Drug safety

authors： Wolkenstein P,Revuz J

更新日期：1995-07-01 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：INTRODUCTION:Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE:Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psyc...

journal_title：Drug safety

authors： Thai-Cuarto D,O'Brien CF,Jimenez R,Liang GS,Burke J

更新日期：2018-04-01 00:00:00

abstract：INTRODUCTION:While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. AIM:The aim of this study was to describe the landscape of technolo...

journal_title：Drug safety

authors： Straub L,Gagne JJ,Maro JC,Nguyen MD,Beaulieu N,Brown JS,Kennedy A,Johnson M,Wright A,Zhou L,Wang SV

更新日期：2019-09-01 00:00:00

abstract：:The New Zealand Intensive Medicines Monitoring Programme (IMMP) undertakes prospective observational cohort studies on selected new drugs in the early postmarketing period using prescription-event monitoring (PEM) methodology with the purpose of identifying signals of previously unrecognised ADRs and establishing risk...

journal_title：Drug safety

authors： Coulter DM

更新日期：2002-01-01 00:00:00

abstract：BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

journal_title：Drug safety

authors： Ramaswamy K,Kozma CM,Nasrallah H

更新日期：2007-01-01 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: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：INTRODUCTION:Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE:We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS:...

journal_title：Drug safety

authors： Witges K,Shafer LA,Zarychanski R,Abou-Setta AM,Rabbani R,Dingwall O,Bernstein CN

更新日期：2020-12-01 00:00:00

abstract：BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...

journal_title：Drug safety

authors： Bailey S,Singh A,Azadian R,Huber P,Blum M

更新日期：2010-02-01 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：:Osteoporosis is the most frequent metabolic condition experienced by elderly individuals. It is characterised by a low bone mass and microarchitectural deterioration of bone tissue leading to an increase in bone fragility and susceptibility to fracture. Osteoporosis constitutes a significant financial burden for healt...

journal_title：Drug safety

authors： Devogelaer JP

更新日期：1998-08-01 00:00:00

abstract：INTRODUCTION:Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication e...

journal_title：Drug safety

authors： Schipperus M,Kaiafa G,Taylor L,Wetten S,Kreuzbauer G,Boshier A,Seesaghur A

更新日期：2019-01-01 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: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：: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：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：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：: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：: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：: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：:Orally administered levodopa remains the most effective symptomatic treatment for Parkinson's disease. The introduction of levodopa therapy is often delayed, however, because of the fear that it might be toxic for the remaining dopaminergic neurons, and thus accelerate the deterioration of the patient's condition. Evi...

journal_title：Drug safety

authors： Murer MG,Raisman-Vozari R,Gershanik O

更新日期：1999-11-01 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：:Data from basic science and clinical studies suggest that hydroxyurea (hydroxycarbamide)-based regimens are effective treatment options for patients with HIV at various stages of disease. In vitro studies of HIV-infected lymphocytes have shown that hydroxyurea: (i) inhibits viral DNA synthesis; (ii) synergistically in...

journal_title：Drug safety

authors： Lisziewicz J,Foli A,Wainberg M,Lori F

更新日期：2003-01-01 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：: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：:Cytokines are now commonly used in the treatment of many conditions, especially cancer, haematological malignancies and chronic viral hepatitis. With some of these cytokines, clinical induction and/or exacerbation of autoimmune manifestations have been observed. This has been the case with interferon-alpha and interfe...

journal_title：Drug safety

authors： Miossec P

更新日期：1997-08-01 00:00:00