Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.

abstract：:Menorrhagia affects the lives of many women. The assessment of menstrual flow is highly subjective and gauging the severity of the condition by objective assessment of menstrual blood loss is impractical. In treating menorrhagia, the primary aim should be to improve quality of life. Women are willing to undergo quite ...

journal_title：Drug safety

authors： Roy SN,Bhattacharya S

更新日期：2004-01-01 00:00:00

abstract：BACKGROUND:Pharmacists have an essential role in improving drug usage and preventing prescribing errors (PEs). PEs at the interface of care are common, sometimes leading to adverse drug events (ADEs). This was the first study to investigate, using a computerized search method, the number, types, severity, pharmacists' ...

journal_title：Drug safety

authors： Abdel-Qader DH,Harper L,Cantrill JA,Tully MP

更新日期：2010-11-01 00:00:00

abstract：BACKGROUND:Clozapine is an antipsychotic medication associated with a lower suicide rate compared with other antipsychotic agents. Clozapine is used specifically in patients for whom previous therapy was inadequate or not tolerated, and is the only antipsychotic agent associated with the development of myocarditis. OB...

journal_title：Drug safety

authors： Haas SJ,Hill R,Krum H,Liew D,Tonkin A,Demos L,Stephan K,McNeil J

更新日期：2007-01-01 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：:Transdermal devices are now marketed for the delivery of systemic medication through the skin. Advantages associated with transdermal drug delivery include avoidance of first-pass metabolism and improved patient compliance. Drugs currently available by this route include scopolamine (hyoscine), nitroglycerin (glyceryl...

journal_title：Drug safety

authors： Carmichael AJ

更新日期：1994-02-01 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：: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

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：:Although heart failure is predominantly caused by cardiovascular conditions such as hypertension, coronary heart disease and valvular heart disease, it can also be an adverse reaction induced by drug therapy. In addition, some drugs have the propensity to adversely affect haemodynamic mechanisms in patients with an al...

journal_title：Drug safety

authors： Slørdal L,Spigset O

更新日期：2006-01-01 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：:Drug-induced QT interval prolongation is now a major concern in safety pharmacology. Regulatory authorities such as the US FDA and the European Medicines Agency require in vitro testing of all drug candidates against the potential risk for QT interval prolongation prior to clinical trials. Common in vitro methods incl...

journal_title：Drug safety

authors： Meyer T,Boven KH,Günther E,Fejtl M

更新日期：2004-01-01 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：: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：:The risk of coronary events with non-steroidal anti-inflammatory drugs has been the subject of much debate since the original trial of rofecoxib raised the issue. Since then, over almost 20 years, such risks have been shown in clinical trials of long-term high-dose users, and in observational studies comparing users w...

journal_title：Drug safety

authors： Moore N

更新日期：2020-04-01 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：OBJECTIVE:During proton pump inhibitor (PPI) use, in clinical trials, headache is one of the most frequently reported adverse events (frequency 1.3 to 8.8%), while results of one observational study indicate that headache is the fifth most frequently reported adverse event (incidence densities 2.5 to 4.6 per 1000 patie...

journal_title：Drug safety

authors： Claessens AA,Heerdink ER,van Eijk JT,Lamers CB,Leufkens HG

更新日期：2002-01-01 00:00:00

abstract：INTRODUCTION:Adverse drug reactions (ADRs) are unintended reactions caused by a drug or combination of drugs taken by a patient. The current safety surveillance system relies on spontaneous reporting systems (SRSs) and more recently on observational health data; however, ADR detection may be delayed and lack geographic...

journal_title：Drug safety

authors： Li Y,Jimeno Yepes A,Xiao C

更新日期：2020-09-01 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：BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...

journal_title：Drug safety

authors： Trenque T,Maura G,Herlem E,Vallet C,Sole E,Auriche P,Drame M

更新日期：2013-07-01 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：BACKGROUND:Pioglitazone is an antidiabetic drug that belongs to the thiazolidinedione (TZD) class of insulin-sensitizing agents. Adverse events to pioglitazone of potential severity are listed in the 'special warnings and special precautions for use' section of the pioglitazone summary of product characteristics (SPC),...

journal_title：Drug safety

authors： Fogg C,Kasliwal R,Shakir SA

更新日期：2009-01-01 00:00:00

abstract：:Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is struct...

journal_title：Drug safety

authors： Adlan AM,Lip GY

更新日期：2013-02-01 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：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：:Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses...

journal_title：Drug safety

authors： Roughead EE,Pratt NL

更新日期：2015-12-01 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 article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...

journal_title：Drug safety

authors： Bergvall T,Norén GN,Lindquist M

更新日期：2019-06-01 00:00:00

abstract：:Postoperative nausea and vomiting (PONV) is an age-old problem; more so since the blooming of ambulatory or day surgery centres within the last 2 decades. The aetiology of PONV is multifactorial. The incidence of PONV is usually higher in women and children than in men. PONV not only causes patient discomfort, anxiety...

journal_title：Drug safety

authors： Sung YF

更新日期：1996-03-01 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：:The available antihyperlipidaemic drugs are generally safe and effective, and major systemic adverse effects are uncommon. However, because of their complex mechanisms of action, careful monitoring is required to identify and correct potential drug interactions. Bile acid sequestrants are the most difficult of these a...

journal_title：Drug safety

authors： Farmer JA,Gotto AM Jr

更新日期：1994-11-01 00:00:00