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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28829213/safety-evaluation-of-trelagliptin-in-the-treatment-of-japanese-type-2-diabetes-mellitus-patients
#1
Kohei Kaku
Trelagliptin is a novel, long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan. The safety and efficacy of trelagliptin has been evaluated in three published clinical trials to date: one phase 2 and two phase 3 studies. As trelagliptin only requires dosing once per week, this new agent has the potential to improve compliance and subsequently, glycaemic control, in patients with T2DM. Areas covered: This article reviews the available safety data for trelagliptin from published clinical trials, and evaluates the published safety profile relative to competitor once-daily and once-weekly DPP-4 inhibitors...
August 22, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28825327/clinical-applications-and-safety-evaluation-of-the-new-cd19-specific-t-cell-engager-antibody-construct-blinatumomab
#2
Anne C Wilke, Nicola Gökbuget
Blinatumomab is a T-cell engager antibody construct with dual specificity for CD19 and CD3, inducing serial lysis of CD19 positive B cells by redirecting cytotoxic T cells. It has been approved for the indication of Ph chromosome negative relapsed or refractory B-acute lymphoblastic leukemia (ALL), but has also been tested in ALL with minimal residual disease, relapsed Ph/BCR-ABL positive ALL, relapsed ALL in pediatric patients and relapsed or refractory non-Hodgkin's lymphoma (NHL). Adverse events have been mainly related to infection and hematological toxicities, as well as cytokine release syndrome and neurotoxicity...
August 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28817316/filling-quality-of-the-reports-of-adverse-drug-reactions-received-at-the-pharmacovigilance-centre-of-s%C3%A3-o-paulo-brazil-missing-information-hinders-the-analysis-of-suspected-associations
#3
Adalton Ribeiro, Silvana Lima, Maria-Elisa Zampieri, Mirtes Peinado, Albert Figueras
Background The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). Research Design and Methods A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm...
August 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28777918/the-importance-of-pharmacoepidemiology-in-pregnancy-implications-for-safety
#4
Justine Benevent, Francois Montastruc, Christine Damase-Michel
Prescription of medications to pregnant women is usually a challenge as the drug benefit has to be considered regarding its potential adverse effects. As medication use is common in pregnant women, by chance or necessity, it gives the opportunity to evaluate the consequences of prenatal drug exposure in real life through pharmacoepidemiologic studies. Area covered: Data sources are numerous. Some of them have been created for the particular purpose of assessing medications during pregnancy. Augmented databases enable the study of delayed effects in late childhood and provide information on potential confounders...
August 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28749713/safety-considerations-surrounding-use-of-treatment-options-for-nausea-and-vomiting-in-pregnancy
#5
Gideon Koren
Nausea and vomiting of pregnancy (NVP) is the most prevalent medical condition during gestation, affecting up to 85% of pregnant women. Many of them hesitate to use medications due to perceived fetal risks. Areas covered: There are two main aspects to medication safety in NVP: The fetal safety of drugs used to treat NVP symptoms, and the risks of untreated NVP. While mild and moderate NVP are not associated with major increase in fetal or maternal risks, and may render protective fetal effects, they have major impact on the quality of life of the mother...
August 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28748724/acid-base-and-electrolyte-disorders-associated-with-the-use-of-antidiabetic-drugs
#6
Theodosios Filippatos, Eleftheria Tzavella, Christos Rizos, Moses Elisaf, George Liamis
The use of antidiabetic drugs is expected to substantially increase since diabetes mellitus incidence rises. Currently used antidiabetic drugs have a positive safety profile, but they are associated with certain acid-base and electrolyte abnormalities. The aim of the review is to present the current data regarding the antidiabetic drugs-associated acid-base and electrolyte abnormalities. Areas covered: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been linked with the scarce, but serious, complication of euglycemic diabetic ketoacidosis, as well as with an increase in serum potassium, magnesium and phosphorus levels...
August 4, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28774214/the-safety-of-bosutinib-for-the-treatment-of-chronic-myeloid-leukemia
#7
Jee Hyun Kong, H J Khoury, Audrey Sunwha Kim, Brittany Gray Hill, Vamsi Kota
Introduction Tyrosine kinase inhibitors (TKIs) are a potentially lifelong treatment for patients with chronic myeloid leukemia (CML). Adverse events (AEs) associated with TKIs are significant impediments in the daily life of patients that can impact compliance, and efficacy. Areas covered This is a review on safety of bosutinib in the treatment of chronic phase CML. Data is extracted from the latest updates of bosutinib phase I/II and III trials. Expert opinion Bosutinib is an effective agent against all phases of CML presently approved for the treatment in patients with resistance or intolerance to prior TKI therapy...
August 3, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28766379/risk-of-gastrointestinal-complications-in-breast-cancer-patients-treated-with-neratinib-a-meta-analysis
#8
Nan Jiang, Xiang-Wei Song, Jing-Jing Lin, Zhan-Yu Wang, Bei-Ning Zhang, Ao Li, Ru-Yi Yan, Hong-Feng Yan, Xiao-Yan Fu, Jin-Lian Zhou, Cheng-Lin Li, Yan Cui
BACKGROUNDS: Neratinib is a potent EGFR/HER2 kinase inhibitor. Gastrointestinal complications (i.e. diarrhea, vomiting and nausea) are the most common adverse events. In this study, we aimed to investigate (1) the overall incidence and relative risk (RR) of diarrhea, vomiting and nausea and (2) whether combination neratinib therapy increased the incidence of gastrointestinal complications versus neratinib alone. METHODS: Relevant studies were identified from the PubMed database, from abstracts presented at the American Society of Clinical Oncology annual conference and from the Web of Science database...
August 2, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28756692/the-safety-of-available-treatments-for-chronic-constipation
#9
Blanca Serrano-Falcon, Enrique Rey
INTRODUCTION: Chronic constipation is a frequent syndrome which, not only causes an appreciable deterioration in quality of life, but also entails a high economic cost due, among other things, to its treatment. This is because of the widespread use of laxatives, even by subjects who have not sought medical care, as well as little patient satisfaction with the treatment. Although this generally involves the use of drugs regarded as safe, there is no clear evidence about their short- and long-term effects, something that complicates appropriate prescription and follow-up by health professionals and hinders therapeutic compliance...
July 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28750567/impact-of-pharmacogenomics-upon-the-therapeutic-response-to-etanercept-in-psoriasis-and-psoriatic-arthritis
#10
Giuseppe Murdaca, Simone Negrini, Ottavia Magnani, Elena Penza, Marco Pellecchio, Francesco Puppo
TNF-α inhibitors have demonstrated efficacy both as monotherapy and in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the treatment of chronic inflammatory immune-mediated diseases. Etanercept is a decoy receptor" for TNF-α and it is composed of two p75 TNF-α receptors fused to human IgG1. Areas covered: We discuss the potential role of pharmacogenetics in predicting the response to etanercept in patients with Ps and PsA. Expert opinion: Pharmacogenetics represents the new frontier for the discovery of potential genetic markers of biological response to TNF-α inhibitors...
July 28, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28748718/diabetes-drugs-and-the-incidence-of-solid-cancers-a-survey-of-the-current-evidence
#11
Marco Tuccori, Irma Convertino, Maria Teresa Galiulo, Alessandra Marino, Alice Capogrosso-Sansone, Corrado Blandizzi
The evaluation of the relationship between the use of antidiabetic drug and the occurrence of cancer is extremely challenging, both from the clinical and pharmacoepidemiological standpoint. This narrative review described the current evidence supporting a relationship between the use of antidiabetic drugs and the incidence of solid cancers. Areas Covered: Data from pharmacoepidemiological studies on cancer incidence were presented for the main antidiabetic drugs and drug classes, including human insulin and insulin analogues, metformin, sulfonylureas, glinides, alpha-glucosidase inhibitors, thiazolidinediones, incretin mimetics, and sodium glucose co-transporter 2 inhibitors...
July 27, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28741382/sodium-glucose-co-transporter-2-inhibitor-luseogliflozin-in-the-management-of-type-2-diabetes-a-drug-safety-evaluation
#12
Daisuke Yabe, Yoshiyuki Hamamoto, Yusuke Seino, Hitoshi Kuwata, Takeshi Kurose, Yutaka Seino
Sodium glucose co-transporter-2 (SGLT2) inhibitors have been developed recently as a new class of anti-diabetic drug, and are becoming widely used in the management of type 2 diabetes (T2D). As these agents have a considerably different glucose-lowering mechanism from those of other anti-diabetic drugs, safe use of this drug class needs to be discussed based on data available from preapproval clinical trials as well as real-world studies. The SGLT2 inhibitor luseogliflozin was developed by Taisho Pharmaceutical Co...
July 25, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28678550/the-safety-of-albiglutide-for-the-treatment-of-type-2-diabetes
#13
Marc S Rendell
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. Area Covered: The safety of albiglutide is discussed. The review encompassed a search of PubMed and a thorough analysis of the European Union and US Food and Drug Administration approval documents. Expert Opinion: Unlike competitor agents, the gastrointestinal side effects of albiglutide are not much greater than placebo...
July 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28730840/the-safety-of-available-and-emerging-options-for-emergency-contraception
#14
Jessica K Lee, Eleanor Bimla Schwarz
Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regarding the safety of EC as well as directions for further study. PubMed was searched for all relevant studies published prior to June 2017. Expert Opinion: All available methods of EC (i.e., ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown...
July 21, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28724335/exploring-the-potential-for-using-drug-indications-to-prevent-look-alike-and-sound-alike-drug-errors
#15
Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff
BACKGROUND: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs. RESEARCH DESIGN AND METHODS: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities...
July 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28699784/cancer-drugs-and-qt-prolongation-weighing-risk-against-benefit
#16
Pierantonio Menna, Emanuela Salvatorelli, Giorgio Minotti
No abstract text is available yet for this article.
July 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28699790/safety-of-available-and-emerging-drug-therapies-for-hyperhidrosis
#17
Christine Hosp, Henning Hamm
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 body areas, mostly the axillae, palms, soles, or head. Secondary hyperhidrosis is caused by an underlying disease or the intake of medications and often involves large parts of the body. Numerous effective therapies with topical or systemic drugs and surgical options are available...
July 16, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28705090/the-safety-of-available-treatments-options-for-neuroendocrine-tumors
#18
A Faggiano, F Lo Calzo, G Pizza, R Modica, A Colao
Neuroendocrine neoplasms (NEN) represent a heterogeneous group of malignancies generally characterized by low proliferation and indolent course. However, about half of the newly diagnosed cases are metastatic and require long-term systemic therapies. Areas covered: this review revise the literature to summarize the current knowledge upon safety of all systemic treatment options available. A total amount of 33 different clinical studies have been considered, including 4 on somatostatin analogues (SSA), 5 on targeted therapies, 10 on peptide receptor radionuclide therapy (PRRT), and 14 on chemotherapy...
July 14, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28697315/an-update-on-anesthetics-and-impact-on-the-brain
#19
Vincenzo Fodale, Vincenzo F Tripodi, Olivia Penna, Fausto Famà, Francesco Squadrito, Epifanio Mondello, Antonio David
While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder...
July 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28697311/breast-cancer-treatment-induced-cardiotoxicity
#20
Samuel Martel, Christian Maurer, Matteo Lambertini, Noam Pondé, Evandro de Azambuja
Breast cancer is the most frequent cancer affecting women worlwide. In every setting, the majority of women are treated with an evergrowing arsenal of therapeutic agents that have greatly improved their outcomes. However, these therapies can also be associated with significant adverse events. Areas covered: This review aims to thoroughly describe the current state of the evidence regarding the potential cardiotoxicity of agents commonly used in the treatment of breast cancer. These include chemotherapeutic agents, anti-HER2 therapies and CDK4/6 and mTOR inhibitors...
July 11, 2017: Expert Opinion on Drug Safety
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