The safety and efficacy of the administration of recombinant activated factor VII in major surgery and trauma patients.

abstract：INTRODUCTION:Although anaphylaxis is a relatively common disorder, clinicians and scientists have debated on how to best define and manage this condition. The current recommendations are focused on the central role of adrenaline, but evidence in support of this therapeutic approach is modest, mainly for the lack of wel...

journal_title：Expert opinion on drug safety

authors： Cervellin G,Sanchis-Gomar F,Lippi G

更新日期：2016-06-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:Bisphosphonates are the most widely used antiresorptive agents for the treatment of osteoporosis. However, the cumulative bisphoshonate exposure and its association with atypical fragility fractures, and the optimum duration of treatment remain obscure. AREAS COVERED IN THIS REVIEW:This review ...

journal_title：Expert opinion on drug safety

authors： Charopoulos I,Orme S,Giannoudis PV

更新日期：2011-01-01 00:00:00

abstract：INTRODUCTION:Amiodarone is the most widely used antiarrhythmic agent, with demonstrated effectiveness against all the spectrum of cardiac tachyarrhythmias. The risk of adverse effects acts as a limiting factor to its utilization especially in the long term. This article systematically reviews the published evidence on ...

journal_title：Expert opinion on drug safety

authors： Santangeli P,Di Biase L,Burkhardt JD,Bai R,Mohanty P,Pump A,Natale A

更新日期：2012-03-01 00:00:00

abstract：INTRODUCTION:Hyperhidrosis affects 4.8% of the U.S. population and has been underestimated by physicians for long time despite considerable interference with quality of life. Many patients suffer from primary (idiopathic) hyperhidrosis which results from over-activity of sympathetic nerves and is restricted to specific...

journal_title：Expert opinion on drug safety

authors： Hosp C,Hamm H

更新日期：2017-09-01 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：INTRODUCTION:Alemtuzumab is a humanised anti-CD52 mAb which has recently been licensed for the treatment of relapsing multiple sclerosis in Europe. AREAS COVERED:The efficacy and safety of alemtuzumab from open label, Phase II and Phase III trials is reported. EXPERT OPINION:Alemtuzumab causes rapid and profound comp...

journal_title：Expert opinion on drug safety

authors： Willis M,Robertson NP

更新日期：2014-08-01 00:00:00

abstract：INTRODUCTION:Secondary preventative therapies are essential for patients undergoing coronary artery bypass graft (CABG) surgery to optimize perioperative and long-term outcomes. Beta-blockers are commonly used to treat patients with coronary artery disease and congestive heart failure (CHF), but their role for CABG pat...

journal_title：Expert opinion on drug safety

authors： Thaper A,Kulik A

更新日期：2018-08-01 00:00:00

abstract：BACKGROUND:Since their initial use in the 1980s, IFNs have become an essential component of the therapy for many diseases such as hepatitis and multiple sclerosis. Although they have been extremely useful in conditions that pose therapeutic challenges, complications associated with their use have been widely reported i...

journal_title：Expert opinion on drug safety

authors： Burdick LM,Somani N,Somani AK

更新日期：2009-07-01 00:00:00

abstract：INTRODUCTION:In the last couple of years, the number of patients with chronic inflammatory rheumatic diseases being treated with TNF α antagonist has increased dramatically. Adalimumab, a fully human monoclonal antibody against TNF α, is one of the most frequently administered TNF α antagonists. Yet, unresolved issues ...

journal_title：Expert opinion on drug safety

authors： Poddubnyy D,Rudwaleit M

更新日期：2011-07-01 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：: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: Rucaparib is increasingly being utilized for women with recurrent ovarian cancer both as treatment and maintenance therapy. Poly-ADP ribose polymerase (PARP) inhibitors like rucaparib are daily oral medication that exploit the DNA repair pathway. The most significant clinical benefit is in those tumors e...

journal_title：Expert opinion on drug safety

authors： Cosgrove CM,O'Malley DM

更新日期：2018-12-01 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:In the 1980s-1990s numerous studies were performed on H2-receptor antagonist inhibition of ethanol first-pass metabolism. Blood alcohol concentrations warranting possible driving under the influence citations in the United States have subsequently dropped from ≥100 mg/dL to 50 mg/dL (Utah in 2019) (30 mg/d...

journal_title：Expert opinion on drug safety

authors： Moody DE

更新日期：2018-09-01 00:00:00

abstract：:Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in ...

journal_title：Expert opinion on drug safety

authors： Miranda MRH,Dubey A,G S R,Charyulu RN

更新日期：2019-10-01 00:00:00

abstract：:Aerosolized delivery of a number of antimicrobial agents has been studied. Despite a theoretical soundness behind this strategy, full consideration of the potential toxicities associated with this mode of administration is imperative. Aerosolized amphotericin B, as both deoxycholate and lipid formulations, has been st...

journal_title：Expert opinion on drug safety

authors： Knechtel SA,Klepser ME

更新日期：2007-09-01 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:In patients with acromegaly, somatostatin analogs (SSA) represent the first choice medical treatment. The long-acting SSA have been found to be effective in controlling growth hormone and IGF-I levels in a high percentage of patients, resulting in an improvement in the quality of life; moreover, these pept...

journal_title：Expert opinion on drug safety

authors： Grasso LF,Auriemma RS,Pivonello R,Colao A

更新日期：2015-08-01 00:00:00

abstract：INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...

journal_title：Expert opinion on drug safety

authors： Swenson ER

更新日期：2014-04-01 00:00:00

abstract：:Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases. GlaxoSmithKline (GSK) has > 100 drugs marketed worldwide. In order to determine which database has the highest statistical power to detect safety signals in three larg...

journal_title：Expert opinion on drug safety

authors： Hammond IW,Gibbs TG,Seifert HA,Rich DS

更新日期：2007-11-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:Clopidogrel is an antiplatelet prodrug widely used in acute coronary syndromes and after intravascular stent placement. Acute or chronic use can cause bleeding, a major adverse effect, which can lead to drug discontinuation or noncompliance with therapy. AREAS COVERED IN THIS REVIEW:The mechani...

journal_title：Expert opinion on drug safety

authors： Mangalpally KK,Kleiman NS

更新日期：2011-01-01 00:00:00

abstract：INTRODUCTION:Development of new drugs in oncology may have implications for cardiovascular risk. This report describes some aspects of our growing knowledge in the area of evaluating benefit-risk and may be of direct importance to scientists working in drug discovery and development. AREAS COVERED:This report of webin...

journal_title：Expert opinion on drug safety

authors： Braddock M,Heilbraun J,Mendzelevski B

更新日期：2013-09-01 00:00:00

abstract：INTRODUCTION:Acne is a common skin condition of the pilosebaceous units that affects the young and old, ranges from moderate to severe and can be treated with an array of options. Topical retinoids are the initial treatment for acne due to their ability to treat comedones, the starting point of acne. AREAS COVERED:Taz...

journal_title：Expert opinion on drug safety

authors： Smith JA,Narahari S,Hill D,Feldman SR

更新日期：2016-01-01 00:00:00

abstract：INTRODUCTION:The management of lupus nephritis (LN) has changed significantly over the last 10 years due to emerging evidence from large randomised clinical trials that produced good quality data and guided the formulation of two key concepts: the induction of remission and the maintenance phase of immunosuppressive th...

journal_title：Expert opinion on drug safety

authors： Velo-García A,Ntatsaki E,Isenberg D

更新日期：2016-08-01 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：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：INTRODUCTION:In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes ...

journal_title：Expert opinion on drug safety

authors： Gerosa M,Meroni PL,Cimaz R

更新日期：2014-12-01 00:00:00

abstract：INTRODUCTION:Evolocumab is an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The PCSK9 inhibitors are the most significant advance in lipid therapy since ...

journal_title：Expert opinion on drug safety

authors： Roth EM

更新日期：2018-01-01 00:00:00

abstract：INTRODUCTION:Cardiovascular disease remains the major contributor to morbidity and mortality in diabetes. From the need to reduce cardiovascular risk in diabetes and to ensure that such risk is not exacerbated by drug treatments, governmental regulators and drug manufacturers have focused on clinical trials evaluating ...

journal_title：Expert opinion on drug safety

authors： Younk LM,Lamos EM,Davis SN

更新日期：2016-09-01 00:00:00

abstract：:Background: Erenumab has recently been approved as a pharmacological treatment for the prevention of migraine. However, the incidence estimates of adverse drug reactions (ADRs) were not consistent among studies. Consequently, pooled measures of the incidences of ADRs that accounts for inter-study heterogeneity are des...

journal_title：Expert opinion on drug safety

authors： Pellesi L,De Icco R,Alawie HY,Andersen M,Liang D,Amirguliyev S,Al-Karagholi MA,Amin FM,Sessa M

更新日期：2020-12-29 00:00:00