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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28395526/ramucirumab-in-the-treatment-of-non-small-cell-lung-cancer
#1
Arrieta Oscar, Zatarain-Barron Zyanya Lucia, Felipe Cardona Andres, Carmona Amir, Lopez Mejia Mariana
Therapeutic options for treating Non-Small Cell Lung Cancer (NSCLC) have recently increased. Ramucirumab (Cyramza), an anti-angionenic agent was approved in 2014 for treatment of several malignancies, including second-line treatment of patients with NSCLC with disease progression on or after platinum-based chemotherapy. Areas covered: We performed a comprehensive search of the literature focused on clinical trials with use of ramucirumab, targeting its evolution in the treatment of NSCLC. This review summarizes the results regarding its safety and efficacy...
April 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28395523/adverse-drug-reactions-reporting-in-calabria-southern-italy-in-the-four-year-period-2011-2014-impact-of-a-regional-pharmacovigilance-project-in-light-of-the-new-european-legislation
#2
Christian Leporini, Giuseppina Marrazzo, Laura Mumoli, Stefania Esposito, Luca Gallelli, Giovanna Mangano, Giacomino Brancati, Emanuela Adele De Francesco, Emilio Russo, Giovambattista De Sarro
BACKGROUND: The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use...
April 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28395515/long-term-safety-experience-with-bendamustine-for-injection-in-a-real-world-setting
#3
Peter Martin, Paul M Barr, Leonard James, Ashutosh Pathak, Brad Kahl
BACKGROUND: Bendamustine hydrochloride (bendamustine) was approved for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Pharmacovigilance data have been collected since bendamustine's approval to enhance understanding of its long-term safety profile. Here we provide an overview of the pharmacovigilance data for bendamustine that have led to label updates related to safety and administration since its approval...
April 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28393639/the-safety-of-extended-release-drug-formulations-for-the-treatment-of-adhd
#4
Ann Childress
Attention-deficit/hyperactivity disorder (ADHD) is a complex neurobehavioral disorder affecting millions of patients worldwide. Effective treatments have been available for more than 60 years in the form of immediate-release (IR) stimulants However, stimulants have a high risk for abuse and are associated with adverse effects Including elevated blood pressure and heart rate, insomnia and decreased appetite. IR formulations also require multiple daily dosing. The search for improved safety, tolerability and convenience has led to the development of multiple extended-release (ER) stimulant and non-stimulant formulations...
April 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28387542/the-risk-of-bleeding-with-the-use-of-antiplatelet-agents-for-the-treatment-of-cardiovascular-disease
#5
Ashwin S Nathan, Sounok Sen, Robert W Yeh
In the presence of injured coronary vascular endothelium, platelets become activated to form hemostatic plugs. While this represents a normal healing response to disrupted vascular endothelium, occlusive cardiovascular disease, as a result of maladaptive thrombus formation, is a major cause of morbidity and mortality. Due to the platelet predominance of arterial thrombi, antiplatelet agents are the mainstay of therapy for arterial cardiovascular disease, though come with a significantly increased risk of bleeding...
April 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28387147/tyrosine-kinase-inhibitors-potential-use-and-safety-considerations-in-hiv-1-infection
#6
Mayte Coiras, Juan Ambrosioni, Francisco Cervantes, José M Miró, José Alcamí
Infection caused by HIV-1 is nowadays a chronic disease due to a highly efficient antiretroviral treatment that is nevertheless, unable to eliminate the virus from the organism. New strategies are necessary in order to impede the formation of the viral reservoirs, responsible for the failure of the antiretroviral treatment to cure the infection. Areas covered: The purpose of this review is to discuss the possibility of using tyrosine kinase inhibitors (TKIs) for the treatment of HIV-1 infection. These inhibitors are successfully used in patients with distinct cancers such as chronic myeloid leukemia...
April 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28387138/cardiovascular-safety-of-liraglutide-for-the-treatment-of-type-2-diabetes
#7
R A Chudleigh, Steve Bain
Liraglutide is a GLP-1 RA that is an option for treatment of T2DM. Typical of all new glucose-lowering agents, its CV safety profile is of great interest. Areas covered: This article outlines the efficacy of the GLP-1 RA liraglutide from RCTs, moving through the pivotal phase 3 LEAD trials, and subsequent meta-analyses to assess CV safety. This review describes evolution of regulatory requirements to obtain safety information through dedicated CVOTs. Expert opinion: Since the FDA mandated that CV outcomes for new diabetes therapies should be assessed via a dedicated CVOT, opinion of their utility in T2DM evolved from cynicism through to enthusiasm...
April 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28349715/a-review-of-existing-and-emerging-digital-technologies-to-combat-the-global-trade-in-fake-medicines
#8
Tim K Mackey, Gaurvika Nayyar
The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally. Areas covered: We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging 'digital' solutions to combat fake medicines...
April 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28351171/releasing-the-brake-safety-profile-of-immune-check-point-inhibitors-in-non-small-cell-lung-cancer
#9
Carlo Genova, Giovanni Rossi, Erika Rijavec, Federica Biello, Giulia Barletta, Marco Tagliamento, Francesco Grossi
Immune check-point inhibitors are now employed as single-agents in current practice for the treatment of advanced non-small cell lung cancer (NSCLC), while combinations of different inhibitors are being evaluated in clinical trials. Although the safety profile of these compounds, with particular reference to drugs targeting programmed death protein 1 (PD-1) and its ligand (PD-L1), is generally considered manageable, peculiar, immune-related toxicities may onset. Areas covered: This review focuses on the immune-related adverse events (irAEs) observed during immune check-point blockade in NSCLC and their management...
March 29, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28333552/treatment-of-multiple-sclerosis-during-pregnancy-safety-considerations
#10
Jan Thone, Sandra Thiel, Ralf Gold, Kerstin Hellwig
Women with multiple sclerosis (MS) are treated early in the disease course with disease modifying therapies (DMT). Updated information is needed on pregnancy outcomes of DMT-exposed pregnancies and the effect of the drug withdrawal on MS disease activity. Areas covered: In this review, we will cover the most important updated management strategies in planning a pregnancy when having MS. Expert opinion: MS itself does not increase the risk of adverse pregnancy outcomes and does not negatively influence the long-term course of the disease...
March 23, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28332422/effect-of-methotrexate-on-bone-and-wound-healing
#11
Ippokratis Pountos, Peter V Giannoudis
INTRODUCTION: Methotrexate (MTX) is one of the most commonly used disease modifying drugs administered for wide spectrum of conditions. Through the expansion of the indications of MTX use, an increasing number of patients nowadays attend orthopaedic departments receiving this pharmacological agent. The aim of this manuscript is to present our current understanding on the effect of MTX on bone and wound healing. AREAS COVERED: The authors offer a comprehensive review of the existing literature on the experimental and clinical studies analysing the effect of MTX on bone and wound healing...
March 23, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28332412/drug-safety-evaluation-of-parathyroid-hormone-for-hypocalcemia-in-patients-with-hypoparathyroidism
#12
Gemma Marcucci, Giuseppe Della Pepa, Maria Luisa Brandi
Hypoparathyroidism is a rare disorder characterized by low serum calcium levels and high serum phosphate levels. This disease is commonly treated with calcium supplements and active vitamin D metabolites or analogues, but large doses of these supplements are often utilized to relieve the symptoms caused by hypocalcemia, without guarantee of a physiological normalization of calcium-phosphate homeostasis. Areas covered: Several studies have investigated replacement therapy with recombinant human PTH [rhPTH (1-84) and rhPTH (1-34)] for subjects with hypoparathyroidism...
March 23, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28279079/the-safety-of-biological-pharmacotherapy-for-the-treatment-of-ulcerative-colitis
#13
REVIEW
Gionata Fiorino, Stefanos Bonovas, Clelia Cicerone, Mariangela Allocca, Federica Furfaro, Carmen Correale, Silvio Danese
Biological agents are effective in ulcerative colitis (UC). Currently, 3 anti-TNF agents (infliximab, adalimumab, and golimumab) and 1 anti-integrin agent (vedolizumab) are approved for the treatment of UC. The mechanism of action of biologic agents can also give rise to several side effects, some even serious. It remains uncertain to what extent biologic treatments may be associated with an increased rate of infections, malignancies and other adverse events Areas covered: Our aim is to review the relevant data available in the literature and briefly summarize the safety profile of biological therapy in UC...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28277842/an-update-on-the-safety-of-psychostimulants-for-the-treatment-of-attention-deficit-hyperactivity-disorder
#14
REVIEW
Annabeth P Groenman, Lizanne J S Schweren, Andrea Dietrich, Pieter J Hoekstra
Methylphenidate is the first-line pharmacological treatment of attention-deficit/hyperactivity disorder (ADHD). Although methylphenidate has a well-established evidence base for treating ADHD, its long-term benefits are unclear. Areas covered: Physical adverse effects, psychiatric adverse events and brain development Expert opinion: Some physical adverse events have been described (e.g. sleep disturbances, growth reduction, loss of appetite), although most are of transient nature. Psychiatric adverse events seem more related to the diagnosis ADHD itself, and not stimulant treatment...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28277841/safety-of-tocilizumab-in-the-treatment-of-juvenile-idiopathic-arthritis
#15
REVIEW
Sandra Helena Machado, Ricardo Machado Xavier
Tocilizumab (TCZ) is a recombinant humanized monoclonal antibody and IL-6 receptor antagonist, currently approved for the treatment of systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) in children aged 2 years or older refractory to conventional treatment. The most common adverse events in patients treated with TCZ were infections, especially in the respiratory tract. The most frequent laboratory abnormalities were altered liver function, neutropenia and elevated cholesterol levels...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276859/meta-analysis-of-randomized-controlled-trials-for-the-incidence-and-risk-of-fatal-adverse-events-in-cancer-patients-treated-with-ipilimumab
#16
Jianhong Zhu, Junyan Wu, Guocheng Li, Jianfang Li, Yin Lin, Zhichao He, Chen Su, Wenxia Zhao, Qianqian Wu, Zepeng Chen, Kaifeng Qiu
BACKGROUND: Ipilimumab is a fully human immunoglobulin G1 monoclonal antibody that increases antitumor T-cell responses. We conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate the risk of FAEs associated with ipilimumab. METHODS: We searched PubMed, EMBASE, and ASCO meeting abstract up to September 2016 for RCT comparing ipilimumab with no ipilimumab on cancer patients. Incidence rates, relative risk ratios (RRs), and 95% confidence intervals (CIs) were calculated using fixed- or random effects models...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276858/the-safety-of-second-line-treatment-options-for-non-small-cell-lung-cancer
#17
REVIEW
Antonio Rossi, Paolo Maione, Giuseppe Santabarbara, Paola Claudia Sacco, Francesca Casaluce, Assunta Sgambato, Maria Luisa Barzelloni, Giovanni Palazzolo, Cesare Gridelli
Non-small-cell lung cancer (NSCLC) patients after first-line therapy ultimately suffer progression. At this time, many patients still have a good performance status and can be considered for further active treatment. Two chemotherapeutic agents, docetaxel and pemetrexed (only in non-squamous histology), and the biological drug anti-epidermal growth factor receptor (EGFR) erlotinib, were approved for clinical use in the second-line treatment of NSCLC patients. In the last few years further new second-line therapies have become available in the clinical practice...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276857/safety-considerations-of-anesthetic-drugs-in-children
#18
REVIEW
Raeford E Brown
Great strides have been made in the last twenty years in providing safe anesthesia care for infants and children. Despite a historical record of safety, recent findings have called to question the toxicities of many anesthetic agents. Observations concerning the inherent safety of these agents, their appropriate management in infants, and new findings which suggest overlooked toxicities will be discussed. Areas covered: A literature search using Pub Med identified journal articles relating to the safety of anesthetic agents in infants and children...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276856/safety-of-alectinib-for-the-treatment-of-metastatic-alk-rearranged-non-small-cell-lung-cancer
#19
REVIEW
Viola Zhu, S H Ou
Patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) may derive significant clinical benefit from targeted therapies against this driver mutation, but progression is virtually inevitable. Alectinib is a next-generation ALK inhibitor that provides a novel treatment option for this group of patients. Areas covered: In this review, we summarize the overall safety and tolerability of alectinib. Specifically, we cover cardiovascular, gastrointestinal, hepatic, musculoskeletal, and respiratory adverse events...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276855/the-safety-of-vedolizumab-for-the-treatment-of-ulcerative-colitis
#20
REVIEW
Gregor Novak, Pieter Hindryckx, Reena Khanna, Vipul Jairath, Brian G Feagan
Vedolizumab is a humanized monoclonal antibody to the α4β7-integrin that blocks lymphocyte trafficking to the gut and is approved for treatment of patients with moderate-to-severe ulcerative colitis (UC). The gut-selective mechanism of action has the potential to improve vedolizumab's safety profile compared to other approved biologic drugs. Areas covered: We review the mechanism of action, efficacy and safety of vedolizumab treatment for UC. The positioning of vedolizumab in management algorithms is also discussed...
April 2017: Expert Opinion on Drug Safety
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