Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

abstract：:In October of 2003, the FDA issued a public health warning stating that preliminary evidence showed selective serotonin re-uptake inhibitors (SSRIs) and related antidepressants might be associated with excess reports of suicidality. In 2004, the FDA convened a committee of neuropsychiatric and pediatric subcommittee m...

journal_title：Expert opinion on drug safety

authors： Gören JL

更新日期：2008-05-01 00:00:00

abstract：:NSAIDs are used extensively worldwide at a cost of billions of dollars annu-ally. Adverse side effects, especially in the gastrointestinal (GI) tract, are uncommon but cause a substantial burden of illness because of the volume of use. Important upper GI complications include dyspepsia, gastric erosions and peptic ulc...

journal_title：Expert opinion on drug safety

authors： Peng S,Duggan A

更新日期：2005-03-01 00:00:00

abstract：INTRODUCTION:Reslizumab, a humanized mAb against IL-5, reduces the number of eosinophils in the blood and lungs. Based on efficacy and safety data from pivotal RCTs, reslizumab had been approved for use as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adults who have a history of ex...

journal_title：Expert opinion on drug safety

authors： Cazzola M,Matera MG,Levi-Schaffer F,Rogliani P

更新日期：2018-04-01 00:00:00

abstract：INTRODUCTION:In 1998, high-dose interleukin-2 (IL-2) was the first immunotherapy approved for the treatment of metastatic melanoma based on durable objective responses documented in a subset of patients but widespread utilization was limited by significant toxicity. Advances in targeted therapy and the emergence of T c...

journal_title：Expert opinion on drug safety

authors： Marabondo S,Kaufman HL

更新日期：2017-12-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:Atorvastatin is the most widely used statin administered in a variety of settings, including primary and secondary prevention of cardiovascular events, in the elderly, in patients with chronic kidney disease and in diabetic patients. Therefore, the safety and tolerability of atorvastatin is of p...

journal_title：Expert opinion on drug safety

authors： Athyros VG,Tziomalos K,Karagiannis A,Mikhailidis DP

更新日期：2010-07-01 00:00:00

abstract：:Introduction: Patients living with schizophrenia have a marked risk of clinically significant weight gain and obesity compared to the general population. The risks have been highlighted following the introduction of second-generation antipsychotics. In turn, obesity is associated with a higher prevalence of cardiovasc...

journal_title：Expert opinion on drug safety

authors： Marteene W,Winckel K,Hollingworth S,Kisely S,Gallagher E,Hahn M,Ebdrup BH,Firth J,Siskind D

更新日期：2019-12-01 00:00:00

abstract：OBJECTIVE:Higher vancomycin concentrations are thought necessary for treatment of deep-seated methicillin-resistant Staphylococcus aureus (MRSA) infection, yet this may result in greater risk of nephrotoxicity. We evaluated the relationship of serum vancomycin trough concentration with clinical outcomes and nephrotoxic...

journal_title：Expert opinion on drug safety

authors： Hermsen ED,Hanson M,Sankaranarayanan J,Stoner JA,Florescu MC,Rupp ME

更新日期：2010-01-01 00:00:00

abstract：INTRODUCTION:Nephrotoxicity is generally considered as the most clinically significant adverse reaction of amphotericin B, and has been reported in up to 80% of amphotericin B recipients during the first 2 weeks of treatment. Numerous experimental and clinical investigations have been performed over the past 4 decades,...

journal_title：Expert opinion on drug safety

authors： Karimzadeh I,Farsaei S,Khalili H,Dashti-Khavidaki S

更新日期：2012-11-01 00:00:00

abstract：:Osteonecrosis of the jaw is a new disease, partly caused by bisphosphonates. It is commonly assumed that the bisphosphonates somehow cause cell death (osteocyte necrosis) within the jawbone, which makes it prone to chronic infection. In this article, an alternative pathogenetic theory is suggested, based on the normal...

journal_title：Expert opinion on drug safety

authors： Aspenberg P

更新日期：2006-11-01 00:00:00

abstract：OBJECTIVE:The aim of this study is to evaluate the safety of cephalosporins, based on utilization and adverse drug events (ADEs). METHODS:This is a retrospective study using data on cephalosporins, obtained from Yangtze River hospital drug information and the Wuhan adverse drug reactions monitoring center database, fr...

journal_title：Expert opinion on drug safety

authors： Ren X,Liu D,Ding N,Huang K,Xiong Y,Du G,Zeng F

更新日期：2012-09-01 00:00:00

abstract：:The use of warfarin in the elderly, particularly for stroke prevention in chronic atrial fibrillation, is steadily increasing. Although the benefits of warfarin are greatest in the elderly, so are the risk of adverse outcomes and the difficulties of anticoagulant management. Clinical systems need to improve to counter...

journal_title：Expert opinion on drug safety

authors： Bereznicki LR,Peterson GM,Jackson SL,Jeffrey EC

更新日期：2006-05-01 00:00:00

abstract：:Introduction: Clozapine remains the most effective antipsychotic for treatment-refractory schizophrenia. However, ~40% of the patients respond insufficiently to clozapine. Clozapine's effects, both beneficial and adverse, have been proposed to be partially attributable to its main metabolite, N-desmethylclozapine (NDM...

journal_title：Expert opinion on drug safety

authors： Costa-Dookhan KA,Agarwal SM,Chintoh A,Tran VN,Stogios N,Ebdrup BH,Sockalingam S,Rajji TK,Remington GJ,Siskind D,Hahn MK

更新日期：2020-01-01 00:00:00

abstract：:Methadone is an interesting analgesic for multiple reasons. The unique properties of the agent, low cost and widespread availability have led to increases in methadone prescribing. Despite advantages, methadone is challenging to work with, particularly in patients with high opioid requirements. Recent concerns regardi...

journal_title：Expert opinion on drug safety

authors： Swegle JM,Wensel DD

更新日期：2008-01-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:HIV-infection has become a chronic disease in paediatric patients with the potential for long-term survival and exposure to antiretroviral (ARV) therapies for 2 decades longer than HIV-infected adults. On the other hand, the administration of ARV to HIV-infected pregnant women has greatly increa...

journal_title：Expert opinion on drug safety

authors： Viganò A,Cerini C,Pattarino G,Fasan S,Zuccotti GV

更新日期：2010-05-01 00:00:00

abstract：INTRODUCTION:Approximately 40-50% of patients with cutaneous melanoma harbor point mutations in BRAF. BRAF and MEK inhibitors in combination are now a standard therapy for advanced BRAFV600-mutated melanoma. Nevertheless, survival rates with the combination are limited, highlighting the need for further therapeutic imp...

journal_title：Expert opinion on drug safety

authors： Indini A,Mandalà M

更新日期：2020-10-01 00:00:00

abstract：:Folic acid supplementation has drawn much attention in recent years for the prevention of Alzheimer's disease and cognitive decline. In this review, the authors describe how current evidence does not support the use of folic acid supplements to protect against cognitive decline. Although a few studies suggest that fol...

journal_title：Expert opinion on drug safety

authors： Schneider JA,Tangney CC,Morris MC

更新日期：2006-07-01 00:00:00

abstract：INTRODUCTION:Patients with end-stage renal disease (ESRD) are considered at higher risk of influenza-related complications and are listed worldwide among the subjects for whom yearly influenza vaccination is strongly recommended. However, influenza vaccination coverage of patients with ESRD is significantly lower than ...

journal_title：Expert opinion on drug safety

authors： Principi N,Esposito S,ESCMID Vaccine Study Group (EVASG).

更新日期：2015-08-01 00:00:00

abstract：INTRODUCTION:Pharmacologic vitreolysis is a strategy used to treat anomalous posterior vitreous detachment, by weakening vitreoretinal adhesion with an intravitreal drug. Pharmacologic vitreolysis facilitates surgery, and abnormalities of the vitreoretinal interface including vitreomacular traction (VMT) and early stag...

journal_title：Expert opinion on drug safety

authors： Morescalchi F,Gambicorti E,Duse S,Costagliola C,Semeraro F

更新日期：2016-09-01 00:00:00

abstract：INTRODUCTION:Cardiac injury is one of the most impairing side effects of anticancer treatment. The extension of the range of available drugs, the use of combination regimens and the association with radiation therapy have improved life expectancy; however, they have also caused a rising typology of cardiac toxicities, ...

journal_title：Expert opinion on drug safety

authors： Minoia C,Giannoccaro M,Iacobazzi A,Santini D,Silvestris N,Fioretti A,Oliva S,Guarini A

更新日期：2012-09-01 00:00:00

abstract：:This review examines current knowledge regarding the safety of probiotic bacteria in man. Tighter and more comprehensive standards and regulations will be developed as probiotic therapy moves from a limited number of products used in the food industry, into more defined therapeutic categories and more complex organism...

journal_title：Expert opinion on drug safety

authors： Henriksson A,Borody T,Clancy R

更新日期：2005-11-01 00:00:00

abstract：BACKGROUND:The nasal cavity is a vulnerable zone which may be damaged by vascular disorders. We systematically assessed the frequency and severity of nasal cavity alterations during bevacizumab treatment, to determine its clinical relevance and factors contributing to its onset. PATIENTS AND METHODS:We conducted a hos...

journal_title：Expert opinion on drug safety

authors： D'Amico M,Pagano M,Pasa A,Puntoni M,Clavarezza M,Gennari A,Gozza A,Zanardi S,Defferrari C,Provinciali N,Campazzi E,Campora S,Paleari L,Marra D,Petrera M,DeCensi A

更新日期：2014-11-01 00:00:00

abstract：:An unprecedented interest in biomarker development has arisen from the increasing use of genomic information and high-throughput technologies in the field of drug development. Monitoring global cellular responses to perturbation due to disease, drug treatment or toxicity is achieved using molecular profiling methods s...

journal_title：Expert opinion on drug safety

authors： Bailey WJ,Ulrich R

更新日期：2004-03-01 00:00:00

abstract：INTRODUCTION:Conventional systemic therapies for psoriasis are associated with serious toxicities that can limit long-term use. In recent years, biological therapies have offered the possibility of long-term therapy with improved safety and efficacy for the treatment of psoriasis. Biological therapies can be classified...

journal_title：Expert opinion on drug safety

authors： Talamonti M,Spallone G,Di Stefani A,Costanzo A,Chimenti S

更新日期：2011-03-01 00:00:00

abstract：INTRODUCTION:Hyperphosphatemia is common in the late stages of chronic kidney disease (CKD) and is associated with elevated parathormone levels, abnormal bone mineralization, extraosseous calcification and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help...

journal_title：Expert opinion on drug safety

authors： Locatelli F,Del Vecchio L,Violo L,Pontoriero G

更新日期：2014-05-01 00:00:00

abstract：INTRODUCTION:Clozapine was first introduced as an antipsychotic in the 1970's but a cluster of deaths, later linked to the drug's risk of agranulocytosis, led to its withdrawal in most countries. However, work in the 1980's established its unique efficacy in treatment resistant schizophrenia (TRS), which constitutes as...

journal_title：Expert opinion on drug safety

authors： Remington G,Lee J,Agid O,Takeuchi H,Foussias G,Hahn M,Fervaha G,Burton L,Powell V

更新日期：2016-09-01 00:00:00

abstract：INTRODUCTION:Dolutegravir (DGV) is the newest integrase inhibitor approved for the treatment of HIV-1 infection in both treatment-naive and experienced adults and adolescents. This article reviews the safety of DGV for the treatment of HIV-1 infection. AREAS COVERED:The PubMed database was searched using the keywords ...

journal_title：Expert opinion on drug safety

authors： Keeshin SW,Feinberg J

更新日期：2015-01-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:Trastuzumab has become a mainstay in the treatment of women with human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer in the metastatic and adjuvant settings. Although trastuzumab is generally well tolerated, cardiac toxicity has emerged as a rare but potentially serious ...

journal_title：Expert opinion on drug safety

authors： Chien AJ,Rugo HS

更新日期：2010-03-01 00:00:00

abstract：INTRODUCTION:The approval of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, and ledipasvir (LDV), a NS5A inhibitor, marked a new chapter in IFN and ribavirin-free treatment of hepatitis C virus (HCV). This drug reduces adverse events associated with IFN therapy. AREAS COVERED:The purpose of this pa...

journal_title：Expert opinion on drug safety

authors： Fazel Y,Lam B,Golabi P,Younossi Z

更新日期：2015-08-01 00:00:00

abstract：INTRODUCTION:The introduction of pneumococcal conjugate vaccines (PCVs) in the routine immunization program has resulted in a significant decline in invasive pneumococcal diseases (IPD) around the world. Preterm infants are a special group at a high risk of invasive infection by encapsulated bacteria. However, their sl...

journal_title：Expert opinion on drug safety

authors： López-Sanguos C,Rivero Calle I,Rodriguez Tenreiro C,Raguindin PF,Martinón-Torres F

更新日期：2019-04-01 00:00:00

abstract：INTRODUCTION:The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in in this population at risk of cardiovascular morbidity. ...

journal_title：Expert opinion on drug safety

authors： Luque-Ramírez M,Ortiz-Flores AE,Nattero-Chávez L,Escobar-Morreale HF

更新日期：2020-12-01 00:00:00