Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety.

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: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:Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different ...

journal_title：Expert opinion on drug safety

authors： Bassetti M,Peghin M,Castaldo N,Giacobbe DR

更新日期：2019-08-01 00:00:00

abstract：BACKGROUND:This meta-analysis has been conducted to determine the risk of elevated transaminases associated with immune checkpoint inhibitors use in patients with cancer. METHODS:Studies eligible for our analysis included randomized Phase II and III trials of patients with cancer on ipilimumab, nivolumab, pembrolizuma...

journal_title：Expert opinion on drug safety

authors： Abdel-Rahman O,ElHalawani H,Fouad M

更新日期：2015-10-01 00:00:00

abstract：INTRODUCTION:Drug-induced parkinsonism (DIP) is the second most common cause of parkinsonism after idiopathic Parkinson's disease (iPD). Initially reported as a complication of antipsychotics, it was later recognized as a common complication of antidepressants, calcium channel antagonists, gastrointestinal prokinetics,...

journal_title：Expert opinion on drug safety

authors： López-Sendón J,Mena MA,de Yébenes JG

更新日期：2013-07-01 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:The number of HIV patients receiving antiretroviral therapy is increasing worldwide, as new infections continue to occur and access to drugs is scaling up in most developing regions. Due to the efficacious nature of combination antiretroviral therapy in most drug-adherent patients, the concerns on the safe...

journal_title：Expert opinion on drug safety

authors： Fernandez-Montero JV,Eugenia E,Barreiro P,Labarga P,Soriano V

更新日期：2013-09-01 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:There is a continuing need for an immunosuppressive therapy that offers a high benefit-risk profile for renal transplant recipients, supporting long-term patient and graft survival while minimizing cumulative nephrotoxicity and other side effects. Belatacept , the first biological agent developed for prima...

journal_title：Expert opinion on drug safety

authors： Grinyó JM,Budde K,Citterio F,Charpentier B

更新日期：2013-01-01 00:00:00

abstract：INTRODUCTION:Triamcinolone acetonide (TA) is a steroidal drug that has been widely administered intravitreally for retinal and choroidal conditions. Safety of steroidal products for intraocular use is essential because of their risk of ocular adverse events. This review comprehensively discusses the safety of intravitr...

journal_title：Expert opinion on drug safety

authors： Veritti D,Di Giulio A,Sarao V,Lanzetta P

更新日期：2012-03-01 00:00:00

abstract：:Drug-induced aseptic meningitis (DIAM) is an important entity. This article reviews the literature on this rare idiosyncratic event which may occur after local or systemic drug administration. The data on this adverse reaction is predominantly collated from anecdotal case reports and case series. ...

journal_title：Expert opinion on drug safety

authors： Hopkins S,Jolles S

更新日期：2005-03-01 00:00:00

abstract：INTRODUCTION:Cardiovascular (CV) diseases are the leading cause of death and disability in the developed countries. Lipid-lowering therapy is a cornerstone of the CV risk modification strategy. The first line treatment for hyperlipidemia is statins, which decrease low-density lipoprotein cholesterol (LDL-C) by 30-50% a...

journal_title：Expert opinion on drug safety

authors： Strilchuk L,Fogacci F,Cicero AF

更新日期：2019-07-01 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：:The aim of this manuscript is to report the safety profile of patients treated with ruboxistaurin mesylate (RBX; LY333531), a selective protein kinase C-beta (PKC-beta) inhibitor, for up to 4 years. Data from patients with diabetes (1396 RBX 32 mg/day; 1408 placebo) were combined from 11 placebo-controlled, double-mas...

journal_title：Expert opinion on drug safety

authors： McGill JB,King GL,Berg PH,Price KL,Kles KA,Bastyr EJ,Hyslop DL

更新日期：2006-11-01 00:00:00

abstract：INTRODUCTION:Over 39,000 diabetic patients are surgically treated for trauma and orthopaedic injuries annually in the UK, yet the effects of diabetic medications on the skeletal system is an under researched and under acknowledged field. AREAS COVERED:This review covers all English language novel experimental data rep...

journal_title：Expert opinion on drug safety

authors： Simpson CM,Calori GM,Giannoudis PV

更新日期：2012-03-01 00:00:00

abstract：INTRODUCTION:Anticonvulsant hypersensitivity syndrome (AHS) is a rare but potentially life-threatening adverse drug reaction, primarily associated with phenytoin, phenobarbital and carbamazepine. It is characterized by a triad of fever, skin eruption and internal organ involvement (usually liver), which occur two to ei...

journal_title：Expert opinion on drug safety

authors： Knowles SR,Dewhurst N,Shear NH

更新日期：2012-09-01 00:00:00

abstract：:Colchicine has been used for over 2000 years. Intravenous (i.v.) colchicine has been used for the treatment of acute gout since the 1950s. I.v. and oral colchicine were 'grandfathered' before the 1969 FDA Phase III trials for drug toxicity became law. Data on toxic reactions are, therefore, based only on passive surve...

journal_title：Expert opinion on drug safety

authors： Schlesinger N

更新日期：2007-11-01 00:00:00

abstract：OBJECTIVE:The aim of this study was to investigate whether the use of statins was associated with breast cancer risk. BACKGROUND:Experimental studies have shown that statins have potential protective effects against cancer. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all p...

journal_title：Expert opinion on drug safety

authors： Chan TF,Wu CH,Lin CL,Yang CY

更新日期：2014-03-01 00:00:00

abstract：:Methotrexate is a commonly prescribed antineoplastic and immune modulating compound that has gained wide acceptance in the management of rheumatoid arthritis, psoriasis, sarcoidosis and a number of neoplastic disorders. Although generally considered safe and easy to use, methotrexate has been associated with a number ...

journal_title：Expert opinion on drug safety

authors： Lateef O,Shakoor N,Balk RA

更新日期：2005-07-01 00:00:00

abstract：:It is estimated that over three-quarters of a million people are injured or die in hospitals each year from adverse drug events (ADEs). The majority of medical errors result from poorly designed healthcare systems rather than from negligence on the part of healthcare providers. In general, healthcare systems rely on v...

journal_title：Expert opinion on drug safety

authors： Anderson JG

更新日期：2004-09-01 00:00:00

abstract：:Many diseases are now treatable with modern drugs. Elderly people, because they suffer from age-related illnesses, stand to gain the most, but they are also at risk from adverse drug reactions (ADRs). There are complex reasons for the increased frequency of ADRs, including poor prescribing, polypharmacy, altered drug ...

journal_title：Expert opinion on drug safety

authors： Beard K

更新日期：2003-05-01 00:00:00

abstract：INTRODUCTION:Brimonidine tartrate and brinzolamide eye drops are often used as third and fourth line treatment options to reduce intraocular pressure (IOP) in the management of glaucoma and ocular hypertension. Better tolerated, more effective topical agents requiring once daily instillation including prostaglandin ana...

journal_title：Expert opinion on drug safety

authors： Lusthaus JA,Goldberg I

更新日期：2017-09-01 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：:Ixabepilone is a semisynthetic analogue of epothilone B, a novel microtubule-stabilizing agent. Preclinical data suggest that its mechanisms of actions are different from those of the most commonly used microtubule-stabilizing agent, paclitaxel. This information in addition to the cytotoxicity of this drug in taxane-r...

journal_title：Expert opinion on drug safety

authors： Gupta D,Mani S

更新日期：2009-01-01 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: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

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：:The widespread application of protocols using gonadotropin-releasing hormone (GnRH) agonists or antagonists in assisted reproduction treatment has led to an increasing number of pregnancies exposed to these drugs. This issue has raised scepticism as to the safety of these medications, concerning both pregnant women an...

journal_title：Expert opinion on drug safety

authors： Tarlatzis BC,Bili H

更新日期：2004-01-01 00:00:00

abstract：:A water soluble derivative of camptothecin, irinotecan (CPT-11) is effective against small-cell lung cancer (SCLC), as well as non-SCLC and gastrointestinal cancers. This extended review of recently concluded and ongoing studies focuses on irinotecan in the treatment of limited (LD) and extensive (ED) SCLC specificall...

journal_title：Expert opinion on drug safety

authors： Kawahara M

更新日期：2006-03-01 00:00:00

abstract：:Thionamides, selective inhibitors of thyroid peroxidase-mediated iodination by tyrosine residues in thyroglobulin, have been effectively used in the treatment of hyperthyroidism. The choices for initial treatment of patients with Graves' disease differ in various countries, and many physicians around the world prefer ...

journal_title：Expert opinion on drug safety

authors： Azizi F

更新日期：2006-01-01 00:00:00