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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28333552/treatment-of-multiple-sclerosis-during-pregnancy-safety-considerations
#1
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
#2
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
#3
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
#4
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...
March 10, 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
#5
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...
March 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28271729/egfr-tki-combination-with-immunotherapy-in-non-small-cell-lung-cancer
#6
Myung-Ju Ahn, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Keunchil Park
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has significantly improved clinical outcomes compared with chemotherapy in non-small cell lung cancer (NSCLC) patients with sensitizing EGFR gene mutation. Areas covered: Almost all patients treated with EGFR TKIs eventually develop acquired resistance. It has been reported that activation of the oncogenic EGFR pathway enhances susceptibility of the lung tumors to PD-1 blockade in mouse model, suggesting combination of PD1 blockade with EGFR TKIs may be a promising therapeutic strategy...
March 8, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28277841/safety-of-tocilizumab-in-the-treatment-of-juvenile-idiopathic-arthritis
#7
Ricardo Machado Xavier, Sandra Helena Machado
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...
March 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28264617/integrated-cardiovascular-safety-multifaceted-considerations-in-drug-development-and-therapeutic-use
#8
J Rick Turner
Cardiovascular safety has become a central component of contemporary drug development and therapeutic use since noncardiovascular drugs can exert cardiovascular harms. Appropriate preapproval investigations and monitoring during clinical practice are therefore advantageous. Areas covered: Integrated cardiovascular safety is a broad field of investigation. This review focuses on three areas of assessment specifically chosen to exemplify advances and challenges in this field: the cardiotoxicity of oncologic agents, off-target blood pressure (BP) increases to noncardiovascular drugs, and the cardiovascular safety of new antidiabetic drugs for type 2 diabetes (T2D)...
March 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276855/the-safety-of-vedolizumab-for-the-treatment-of-ulcerative-colitis
#9
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...
March 5, 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
#10
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...
March 3, 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
#11
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...
March 1, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28276857/safety-considerations-of-anesthetic-drugs-in-children
#12
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...
March 1, 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
#13
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...
February 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28095258/the-safety-of-treatment-options-available-for-gout
#14
Naomi Schlesinger
Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management...
January 30, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28215112/corrigendum
#15
(no author information available yet)
No abstract text is available yet for this article.
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28150516/efficacy-and-safety-of-fixed-ratio-combination-of-insulin-degludec-and-liraglutide-ideglira-for-the-treatment-of-type-2-diabetes
#16
REVIEW
Louise Vedtofte, Filip K Knop, Tina Vilsbøll
Type 2 diabetes (T2D) is a progressive disease with increasing prevalence in most countries. The majority of patients with T2D have inadequate glycaemic control, which increases the risk of diabetic complications later in life. New therapies with improved safety profiles are required to tackle the progressive nature of T2D. Areas covered: The efficacy and safety profile of IDegLira - a once-daily, fixed-ratio combination of insulin degludec and liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), for the treatment of T2D - has been extensively evaluated...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28140680/paliperidone-for-the-treatment-of-schizophrenia-and-schizoaffective-disorders-a-drug-safety-evaluation
#17
REVIEW
M C Mauri, A Reggiori, S Paletta, C Di Pace, A C Altamura
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 schizophrenia symptoms and clinical benefits were maintained also in the long-term treatments. Paliperidone ER and PP are generally well tolerated with a predictable adverse event profile. Areas covered: Data from studies evaluating safety and tolerability in the acute and maintenance treatment of schizophrenia with paliperidone are reviewed...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28132578/safety-evaluation-of-apremilast-for-the-treatment-of-psoriasis
#18
A Dattola, E Del Duca, R Saraceno, T Gramiccia, L Bianchi
Psoriasis (PSo) is a chronic inflammatory skin disease associated with co-morbidities such as hypertension, diabetes, dyslipidemia and metabolic syndrome. It is a typothypical Th1/Th17 disease that affects from 2 to 3% of the world population. Numerous are the drugs that can be used in our clinical practice; the choice of these drugs depends on the characteristics of the patient. Areas covered: Apremilast is the first oral small molecules to receive FDA approval for the treatment of adults with active psoriasis and psoriatic arthritis...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28116937/the-safety-of-mepolizumab-for-the-treatment-of-asthma
#19
REVIEW
E Leung, K Al Efraij, J M FitzGerald
Asthma is an airway disease characterized by airway inflammation. It is associated with significant morbidity, mortality, and costs to the healthcare system and society. Interleukin-5 (IL-5) was identified for its role in eosinophil development, maturation, and survival in tissues, which has been related to disease severity and airway eosinophilia. Areas covered: In this review, we will present the pharmacokinetics and dynamics of mepolizumab in addition to efficacy and safety data. Expert Opinion: Mepolizumab is novel, new, first-in-class therapy targeting IL-5...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28103444/efficacy-and-safety-of-a-recombinant-factor-viii-produced-from-a-human-cell-line-simoctocog-alfa
#20
REVIEW
Massimo Franchini, Pier Mannuccio Mannucci
The development of inhibitors against infused factor VIII (FVIII) has a detrimental impact on health and quality of life of patients with hemophilia A. Several observational studies and a recently published randomized trial indicate that the inhibitor risk in previously untreated patients (PUPs) is higher following the use of recombinant FVIII (rFVIII) products compared with plasma-derived FVIII concentrates. There is currently a great interest towards newer rFVIII products that adopt various technological solutions to reduce the inhibitor risk...
March 2017: Expert Opinion on Drug Safety
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