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Expert Opinion on Drug Safety

Fabio Carfagna, Lucia Del Vecchio, Giuseppe Pontoriero, Francesco Locatelli
Hyperphosphatemia is common in late stages of chronic kidney disease and is often associated with elevated parathormone levels, abnormal bone mineralization, extra-osseous calcification, and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help control plasma phosphorus levels. Although effective at lowering serum phosphorus, they all have safety, tolerability, and compliance issues that need to be considered when selecting which one to use. Areas covered: This paper reviews the most established treatment options for hyperphosphatemia, in patients with chronic kidney disease, focusing on the new inhibitors of active phosphate absorption...
May 21, 2018: Expert Opinion on Drug Safety
Julieta González, Matías Quiroga, Vicente Escudero-Vilaplana, Roberto Collado-Borrell, Ana Herranz-Alonso, María Sanjurjo Sáez
BACKGROUND: Oral antineoplastic agents (OAA) have reached 30-50% of all antineoplastic treatments. Although they seem safer than parenteral therapy, many severe problems can occur if the dose is not adequately adjusted in special situations. Our objective is to create a comprehensive guide with dosage adjustment recommendations for OAA in cases of renal and hepatic impairment and hematologic toxicities. RESEARCH DESIGN AND METHODS: We analyzed all OAA approved by EMA in July 2017...
May 21, 2018: Expert Opinion on Drug Safety
Philip Hazell
No abstract text is available yet for this article.
May 21, 2018: Expert Opinion on Drug Safety
Helen Koechlin, Joe Kossowsky, Jens Gaab, Cosima Locher
SSRIs and SNRIs are prescribed as first-line pharmacological treatment for common mental disorders in children and adolescents. Despite their efficacy, they have a high risk for adverse events and exhibit a substantial placebo response. This editorial provides some background on the current evidence on the topic and suggests to carefully weigh the benefits of SSRIs and SNRIs against their potential harms. Therefore, the authors present two different set of conclusions - one for clinical practice, and one for future research designs...
May 21, 2018: Expert Opinion on Drug Safety
Ramón García-Sanz, Cristina Jiménez, Verónica González de la Calle, María Eugenia Sarasquete
Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disease with serum IgM monoclonal component and bone marrow infiltration by lymphoplasmacytic lymphoma. Traditional therapy was based on that regimens used for closely related entities, such as chronic lymphocytic leukemia or multiple myeloma. This resulted in a lack of drugs specifically approved for WM, until the discovery of the BTK inhibitors. Areas covered. Two main therapeutic attitudes are possible: 1) conventional therapies based on combinations with alkylating agents or proteasome inhibitors with steroids and anti-CD20 monoclonal antibodies, or; 2) new approaches with BTK inhibitors, usually alone...
May 17, 2018: Expert Opinion on Drug Safety
Fabrizio Benedetti, Aziz Shaibani
No abstract text is available yet for this article.
May 16, 2018: Expert Opinion on Drug Safety
Julia Martinez-Perez, M Carmen Riesco-Martinez, Rocio Garcia-Carbonero
TAS102 is an oral thymidine-based nucleoside analogue that has been approved for the treatment of patients with metastatic colorectal cancer (mCRC) previously treated with, or not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and, if RAS wild-type, anti-epidermal growth factor receptor (EGFR) therapy. The pivotal RECOURSE phase III trial demonstrated a significant improvement in disease control rate, progression-free (PFS) and overall survival (OS) as compared with placebo in patients with refractory mCRC...
May 10, 2018: Expert Opinion on Drug Safety
Simon Dagenais, Richard Scranton, Andrew R Joyce, Catherine C Vick
BACKGROUND: Local anesthetic systemic toxicity (LAST) is a rare but potentially serious adverse event . METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System were examined for liposomal bupivacaine (LB), bupivacaine, or other injectable local anesthetics. Possible LAST cases were identified based on MedDRA system organ classes (Approach 1), a recent publication (Approach 2), and a novel approach based on LAST literature (Approach 3)...
May 10, 2018: Expert Opinion on Drug Safety
Evgenios I Metaxas, Evangelos Balis
Bronchodilators, namely long-acting inhaled β2-agonists and long-acting muscarinic antagonists, are the first-line medications for chronic obstructive pulmonary disease (COPD). The safety of these medicines is of great concern since COPD patients usually have other co-morbidities such as cardio- and cerebrovascular diseases. Areas covered: In this review we present information about the safety and the use of indacaterol in COPD. Indacaterol is the first once-daily, long-acting inhaled β2-agonist approved for COPD...
May 9, 2018: Expert Opinion on Drug Safety
Paola Rogliani, Josuel Ora, Maria Gabriella Matera, Mario Cazzola, Luigino Calzetta
Introduction Long-acting β2 -adrenoceptor (β2 -AR) agonists (LABAs) plus long-acting muscarinic antagonists (LAMAs) is the cornerstone for treating chronic obstructive pulmonary disease (COPD). LABA/LAMA combinations elicit clinical and functional synergistic interaction, and such an interaction should permit to reduce the dose of each monocomponent in the drug mixture to minimize the risk of adverse events (AEs). Overall, currently available LABA/LAMA fixed-dose combinations (FDCs) combine the drugs at the same doses of formulations designed for a single drug...
May 1, 2018: Expert Opinion on Drug Safety
Ion G Motofei
No abstract text is available yet for this article.
April 30, 2018: Expert Opinion on Drug Safety
Gary Ong, Michael Manyak, Zrinka Lulic
No abstract text is available yet for this article.
April 30, 2018: Expert Opinion on Drug Safety
Bertram Pitt, Dahlia Garza
Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions. Areas covered: We review pooled data from two clinical trials of patiromer in patients with CKD and HK, safety of patiromer in special populations, drug-drug interaction (DDI) studies, and other studies in healthy volunteers...
April 22, 2018: Expert Opinion on Drug Safety
Konstantinos Z Vardakas, Georgios D Kalimeris, Nikolaos A Triarides, Matthew E Falagas
β-lactams have been consistently associated with the majority of drug-related adverse events. Generally, these are mild under proper dosing and judicious selection. Areas covered: Immediate hypersensitivity reactions are the most feared adverse events encountered after β-lactam administration. Emerging evidence shows that immediate reactions are not as common as previously thought. Specialist consultation and testing seems prudent before a patient is officially declared allergic to β-lactams. The risk of cross-reactions between not only members of the β-lactam super-family but also between specific classes is also lower than previously thought...
April 10, 2018: Expert Opinion on Drug Safety
Kristin J Meyers, Himanshu P Upadhyaya, Robert Goodloe, Ludmila A Kryzhanovskaya, Marie A Liles-Burden, Nicole A Kellier-Steele, Michele Mancini
OBJECTIVE: Atomoxetine is a non-stimulant drug indicated for the treatment of attention-deficit/hyperactivity disorder in children aged ≥6 years, adolescents, and adults. In this retrospective cohort study, the incidence and risk of dystonia in children and adolescents treated with atomoxetine was compared to a propensity score-matched cohort of stimulant users. METHODS: Data between 01 January 2006 and 31 December 2014 from patients aged 6-17 years in the Truven Health Analytics MarketScan database were used to generate two cohorts of patients: (1) atomoxetine users and (2) stimulant (methylphenidates or amphetamines) users...
April 6, 2018: Expert Opinion on Drug Safety
Chen Zou
Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016...
April 6, 2018: Expert Opinion on Drug Safety
Fabio Lugoboni, Antonio Mirijello, Laura Morbioli, Elena Arzenton, Roberto Leone, Marco Faccini, Rebecca Casari, Salvatore De Cosmo, Antonio Gasbarrini, Giovanni Addolorato
BACKGROUND: Several side-effects related to prolonged benzodiazepines (BZD) use have been reported. Given the primary role of liver in BZD metabolism, toxicity related to prolonged high-dose BZD use could be conceivable. No data are available on the long-term impact of high-dose BZD use on liver. RESEARCH DESIGN AND METHODS: A total of 201 BZD mono-abusers admitted to an Addiction Unit for detoxification were evaluated. Liver enzymes were evaluated at admission, before starting any treatment...
April 6, 2018: Expert Opinion on Drug Safety
Maurizio Sessa, Concetta Rafaniello, Cristina Scavone, Annamaria Mascolo, Gabriella di Mauro, Annamaria Fucile, Francesco Rossi, Liberata Sportiello, Annalisa Capuano
BACKGROUND: Statin treatment is often associated with poor adherence, which may be due to the onset of adverse drug reactions (ADRs). We investigated on potential risk factors related to preventable cases of statin-induced ADRs and to the discontinuation of statin therapy. METHODS: We performed a study using the database of Italian spontaneous reporting. The target population for the preventability assessment was all patients with suspected statin-induced ADRs deriving from Campania Region (a territory of Southern Italy) between 2012 and 2017...
April 5, 2018: Expert Opinion on Drug Safety
Sandro Gentile, Alessandra Fusco, Sara Colarusso, Marco Piscopo, Maria Rosaria Improta, Marco Corigliano, Emilia Martedi, Domenica Oliva, Antonietta Santorelli, Rosa Simonetti, Armando Giammarco, Caterina Colella, Luigia Miretto, Alessandra D'Alessandro, Viviana Russo, Giuseppina Guarino, Giampiero Marino, Gerardo Corigliano, Felice Strollo
BACKGROUND: Incorrect insulin administration techniques may greatly affect metabolic control in T2DM people. The aim of our study was to compare glycemic control associated with a concentrated insulin analog preparation (U-200 lispro) in people with T2DM to the one observed with standard U-100 lispro. METHODS: 126 patients with T2DM were enrolled. Half of them were randomized to U-100 lispro, half to U-200 and after 12 weeks they were switched to the other preparation for 12 weeks...
March 22, 2018: Expert Opinion on Drug Safety
Cathy Hardalo, Thomas P Lodise, Monique Bidell, Shawn Flanagan, Carisa De Anda, Steven Anuskiewicz, Philippe Prokocimer
BACKGROUND: We evaluated safety and tolerability of tedizolid phosphate at the 200-mg once-daily dose approved for 6-day treatment of skin and skin-structure infections. RESEARCH DESIGN AND METHODS: Clinical adverse event (AE) and laboratory data were pooled across completed clinical studies (13 phase 1, two phase 2, and two phase 3), for all participants who received ≥1 dose of tedizolid 200 mg, linezolid 600 mg (phase 3 only), or placebo (phase 1 only). RESULTS: 1280 participants received tedizolid (phase 1: n = 355; phase 2/3: n = 925)...
March 12, 2018: Expert Opinion on Drug Safety
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