The safety of black cohosh (Actaea racemosa, Cimicifuga racemosa).

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:Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumor. Its action is mediated by its affinity to somatostatin receptors, especially sst2 and ...

journal_title：Expert opinion on drug safety

authors： Godara A,Siddiqui NS,Byrne MM,Saif MW

更新日期：2019-01-01 00:00:00

abstract：:Millions of women worldwide use the combined oral contraceptive pill as an effective form of contraception. However, the focus on its side effects to date has mainly been on physical aspects, even though the most commonly stated reason for discontinuation is depression. There are surprisingly few large studies investi...

journal_title：Expert opinion on drug safety

authors： Kulkarni J

更新日期：2007-07-01 00:00:00

abstract：:Psychosis in Alzheimer's disease is common and troublesome. The impact on the quality of life of both patients and caregivers is high and drug treatments raise concern in terms of both efficacy and safety. Therefore, identifying the risk factors that play an important role in the onset of psychosis is mandatory for th...

journal_title：Expert opinion on drug safety

authors： Cancelli I,Beltrame M,D'Anna L,Gigli GL,Valente M

更新日期：2009-09-01 00:00:00

abstract：BACKGROUND:Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous rep...

journal_title：Expert opinion on drug safety

authors： Antonazzo IC,Raschi E,Forcesi E,Riise T,Bjornevik K,Baldin E,De Ponti F,Poluzzi E

更新日期：2018-09-01 00:00:00

abstract：:The optimum anti-HIV drug has yet to be found. This paper will summarise some of the oral adverse effects associated with antiretroviral agents against HIV. The development of antiretroviral drugs for the treatment of HIV infection has been aimed at the inactivation of two HIV enzymes: reverse transcriptase and protea...

journal_title：Expert opinion on drug safety

authors： Diz Dios P,Scully C

更新日期：2002-11-01 00:00:00

abstract：INTRODUCTION:Albiglutide is a marketed long acting GLP-1 receptor agonist (GLP-1 RA) administered by weekly injection. It has significantly less gastrointestinal side effects than other GLP-1 RAs in current use but does not improve HbA1c or promote weight loss to the same extent as competitor agents such as liraglutide...

journal_title：Expert opinion on drug safety

authors： Rendell MS

更新日期：2017-09-01 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：INTRODUCTION:Trabectedin gained the approval by the European Medicines Agency (EMA) in 2007 for the treatment of patients affected by soft-tissue sarcomas (STS). Its safety and activity profiles have been assessed in many clinical trials as well as in standard clinical practice for > 10 years. AREAS COVERED:This artic...

journal_title：Expert opinion on drug safety

authors： Martin-Liberal J,Judson I

更新日期：2013-11-01 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：OBJECTIVE:To review long-term safety data from the rollover study ETV-901, focusing on adverse events (AEs) with a potential nucleos(t)ide association. METHODS:The open-label study ETV-901 (AI463901) assessed the safety of entecavir in chronic hepatitis B patients who received entecavir, lamivudine or adefovir monothe...

journal_title：Expert opinion on drug safety

authors： Manns MP,Akarca US,Chang TT,Sievert W,Yoon SK,Tsai N,Min A,Pangerl A,Beebe S,Yu M,Wongcharatrawee S

更新日期：2012-05-01 00:00:00

abstract：INTRODUCTION:Fingolimod (Gilenya®, FTY720) is an oral sphingosine-1-phosphate analogue that was approved by the FDA in 2010 for the treatment of relapsing forms of multiple sclerosis (MS). Fingolimod's mechanism of action is primarily related to lymphocyte sequestration in primary and secondary lymphoid tissues. Phase ...

journal_title：Expert opinion on drug safety

authors： Ward MD,Jones DE,Goldman MD

更新日期：2014-07-01 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：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:The emergence of multidrug-resistant (MDR) infections has been extensively observed worldwide and has become a priority issue over past decade. Tigecycline , a broad spectrum antibiotic covering against many MDR organisms, has been widely used. However, recent meta-analysis studies have raised a concern fo...

journal_title：Expert opinion on drug safety

authors： Kaewpoowat Q,Ostrosky-Zeichner L

更新日期：2015-02-01 00:00:00

abstract：INTRODUCTION:Gestational diabetes mellitus (GDM), the most frequent medical complication of pregnancy, is associated with several adverse outcomes over the short- and long-term for both mother and offspring. Standard treatment for GDM consists of insulin injections. Oral hypoglycemic agents (OHAs), on the other hand, a...

journal_title：Expert opinion on drug safety

authors： Maymone AC,Baillargeon JP,Ménard J,Ardilouze JL

更新日期：2011-03-01 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：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：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：IMPORTANCE OF THE FIELD:Despite the beneficial effect of imatinib treatment in chronic myeloid leukemia patients, some patients develop resistance and/or intolerance and need a switch to second-generation tyrosine kinase inhibitors. Dasatinib is indicated for chronic myeloid leukemia patients with resistance or intoler...

journal_title：Expert opinion on drug safety

authors： Breccia M,Alimena G

更新日期：2010-09-01 00:00:00

abstract：INTRODUCTION:Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for ...

journal_title：Expert opinion on drug safety

authors： Blauvelt A

更新日期：2016-10-01 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：INTRODUCTION:Atrial fibrillation (AF) is a cause of significant morbidity and mortality. Catheter ablation for AF (CAAF) has emerged as an effective treatment option of rhythm control for patients with symptomatic AF. However, the risk of thromboembolism and bleeding in the periprocedural period represent a worrisome c...

journal_title：Expert opinion on drug safety

authors： Briceño DF,Madan N,Romero J,Londoño A,Villablanca PA,Natale A,Di Biase L

更新日期：2017-07-01 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：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：INTRODUCTION:Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER) oral formulation and a long-acting injectable paliperidone palmitate (PP) formulation. Paliperidone has demonstrated efficacy in the reduction of acute schizoph...

journal_title：Expert opinion on drug safety

authors： Mauri MC,Reggiori A,Paletta S,Di Pace C,Altamura AC

更新日期：2017-03-01 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：BACKGROUND:The abuse and diversion of pharmacological agents with CNS mechanisms of action is an important concern from governmental, regulatory, public health and safety perspectives. In recent years, there have been an increased number of reports concerning the abuse and diversion of quetiapine in forensic population...

journal_title：Expert opinion on drug safety

authors： Tcheremissine OV

更新日期：2008-11-01 00:00:00

abstract：:Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database. Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or...

journal_title：Expert opinion on drug safety

authors： Wei R,Jia LL,Yu YC,Nie XL,Song ZY,Fan DF,Xie YF,Peng XX,Zhao ZG,Wang XL

更新日期：2019-05-01 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