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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28636836/antiviral-treatment-of-hepatitis-c-in-renal-transplant-patients-safety-issues
#1
Stella De Nicola, Massimo Colombo
No abstract text is available yet for this article.
June 21, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627951/the-safety-of-bruton-s-tyrosine-kinase-inhibitors-for-the-treatment-of-chronic-lymphocytic-leukemia
#2
Phu N Tran, Susan O'Brien
The approval of ibrutinib has revolutionized the therapeutic landscape of chronic lymphocytic leukemia (CLL). Currently ibrutinib is indicated for patients that are both treatment naïve as well as those with relapsed CLL. Ibrutinib is generally well-tolerated with durable responses that improve over time in most patients. Important toxicities include atrial fibrillation and bleeding. Areas Cover: This review covers the pharmacokinetics, pharmacodynamics, safety and efficacy of ibrutinib in the treatment of CLL...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627943/the-efficacy-and-safety-of-adjuvant-interferon-alfa-therapy-in-the-evolving-treatment-landscape-for-resected-high-risk-melanoma
#3
Van Anh Trinh, Chrystia Zobniw, Wen-Jen Hwu
Patients with resected stage II or III melanoma are at high risk of recurrence, with 5-year mortality rate of 40-60%. Adjuvant interferon-alfa has demonstrated a small RFS and OS benefit versus observation in this patient population. However, the adjuvant treatment landscape is evolving rapidly. Areas covered: This review aims to summarize the safety and efficacy profiles of adjuvant IFNα/PEG-IFNα, revisit the controversy surrounding its application, and reappraise its position in the rapidly changing treatment landscape of resected melanoma...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627939/off-label-prescribing-for-children-with-chronic-diseases-in-nigeria-findings-and-implications
#4
Kazeem Adeola Oshikoya, Ibrahim Adekunle Oreagba, Brian Godman, Joseph Fadare, Samuel Orubu, Amos Massele, Idowu Odunayo Senbanjo
BACKGROUND AND AIMS: Prescribing medicines in an off-label manner for children with chronic conditions is sparsely documented, even more so among developing countries. This needs addressing. The objective was to investigate the extent of this prescribing among children with epilepsy, asthma, and sickle cell anaemia in Nigeria. METHODS: Prescriptions for children ≤16 years documented in their case files that attended paediatric clinics in Lagos, Nigeria, for these three conditions between January and October 2015, were reviewed retrospectively to extract data on the medicines prescribed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627937/the-safety-of-intra-articular-injections-for-the-treatment-of-knee-osteoarthritis-a-critical-narrative-review
#5
Christelle Nguyen, François Rannou
International guidelines recommend that the management of knee osteoarthritis (OA) combine both nonpharmacological and pharmacological interventions. Intra-articular (IA) therapies are considered part of this multimodal approach and are well-established Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments. Areas covered. Safety data for knee OA, including IA corticosteroids, hyaluronic acid, platelet-rich plasma and botulinum toxin are critically reviewed, and evidence- and pratice-based measures to improve safety of IA therapies are discussed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28608717/the-safety-of-non-biological-treatments-in-ulcerative-colitis
#6
Edoardo Troncone, Giovanni Monteleone
Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a relapsing-remitting course that determines significant morbidity and can associate with local complications and/or extra-intestinal manifestations. Pharmacological therapies are often required for a lifetime with possible risks of toxicity and side effects. Areas covered: Non-biological therapies (i.e. aminosalicylates, corticosteroids and immunosuppressive drugs) are widely used in UC patients for controlling the active phases of the disease and maintaining remission...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28621560/the-risks-associated-with-prenatal-antidepressant-exposure-time-for-a-precision-medicine-approach
#7
Lars Henning Pedersen
Introduction The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to differences in risks between the study populations related to variations in e.g. degree of depression, type of antidepressant, and lifestyle. Areas covered The literature on the safety of antidepressants in pregnancy is vast and thousands of papers have been published mainly in the last decades...
June 16, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28621159/dual-antiretroviral-therapy-for-hiv-infection
#8
Vicente Soriano
For two decades' triple combinations of antiretrovirals have been the standard treatment for HIV infection. The challenges of such lifelong therapy include long-term side effects, high costs and reduced drug adherence. The recent advent of more potent and safer antiretrovirals has renewed the interest for simpler HIV regimens. Areas covered: We discuss the pros and cons of dual antiretroviral therapies in both drug-naïve and in treatment-experienced patients with viral suppression (switch strategy). Expert Opinion: Some dual antiretroviral regimens are safe and efficacious, particularly as maintenance therapy...
June 16, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28571476/the-safety-and-tolerability-of-nintedanib-in-the-treatment-of-idiopathic-pulmonary-fibrosis
#9
Vincent Cottin
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease that primarily affects older individuals. Nintedanib, a tyrosine kinase inhibitor, has been approved for the treatment of IPF in several countries. The safety and tolerability of nintedanib have been investigated in clinical trials and in real-world studies (compassionate use programs and post-marketing surveillance). Areas covered: Most frequent adverse events reported in patients treated with nintedanib (gastrointestinal); additional adverse events of special interest (elevations in liver enzymes, bleeding, cardiovascular adverse events); recommendations for managing adverse events...
June 15, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28475380/thromboembolic-and-bleeding-risks-in-patients-undergoing-atrial-fibrillation-ablation-oral-anticoagulation-perspectives
#10
David F Briceño, Nidhi Madan, Jorge Romero, Alejandra Londoño, Pedro A Villablanca, Andrea Natale, Luigi Di Biase
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 complication of this therapy. The reported incidence of thromboembolic and bleeding events associated with CAAF varies from 0.9% to 5% depending on the CAAF strategy and the anticoagulation regimen used in the periprocedural period...
June 15, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28571494/cardiovascular-pleiotropic-effects-of-statins-and-new-onset-diabetes-is-there-a-common-link-do-we-need-to-evaluate-the-role-of-katp-channels
#11
Devindra Sehra, Sudhish Sehra, Shiv Tej Sehra
Statins are considered the main stay of treatment in the prevention of cardio-vascular morbidity and mortality. They have multiple pleiotropic effects, like stabilization of atherosclerotic plaques, inhibition of platelet aggregation, and vascular smooth muscle proliferation; in addition to their lipid lowering action. Statins manifest these pleiotropic effects because they activate KATP channels in the cardiac and vascular tissue. Simultaneous activation of the KATP channels by statins in β cells of pancreas may inhibit insulin release which may lead to diabetes...
June 13, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28573876/a-safety-assessment-of-biological-therapies-targeting-the-il-23-il-17-axis-in-inflammatory-bowel-diseases
#12
Bram Verstockt, Barbara Deleenheer, Gert Van Assche, Séverine Vermeire, Marc Ferrante
Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab...
June 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28571500/safety-of-oral-tenofovir-disoproxil-fumarate-based-hiv-pre-exposure-prophylaxis-use-in-lactating-hiv-uninfected-women
#13
Kenneth K Mugwanya, Grace John-Stewart, Jared Baeten
In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option for women who are lactating but data are limited on its safety during the lactation period. Areas covered: We provide a concise synthesis and summary of current evidence on the safety of TDF-based PrEP during breastfeeding...
June 8, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28569569/nonsteroidal-anti-inflammatory-drugs-and-cardiovascular-safety-translating-pharmacological-data-into-clinical-readouts
#14
Stefania Tacconelli, Annalisa Bruno, Rosalia Grande, Patrizia Ballerini, Paola Patrignani
The pharmacological management of pain includes the use of nonsteroidal anti-inflammatory drugs(NSAIDs). They comprise traditional(t) NSAIDs and selective cyclooxygenase(COX)-2 inhibitors (named coxibs). The analgesic and anti-inflammatory effects of NSAIDs are dependent on the extent and duration of COX-2 inhibition in the spinal cord and inflammatory sites. However, the simultaneous inhibition of COX-2 in the vasculature translates into a prothrombotic phenotype and promotes hypertension and heart failure...
June 8, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28548608/a-descriptive-review-of-additional-risk-minimisation-measures-applied-to-eu-centrally-authorised-medicines-2006-2015
#15
Annalisa Rubino, Esther Artime
BACKGROUND: Guidance on therapeutic risk management, first released in EU in 2005, was updated in 2012-2013 with increased requirements on additional risk minimisation measures (aRMM). This study describes aRMM imposed at initial EU central marketing authorisation of medicines in 2006-2015. METHODS: Non-generic medicines authorised between 01/01/2006 and 31/12/2015 were identified in the European Public Assessment Report (EPAR) database. Data on aRMM, including effectiveness measures were extracted, tabulated and analysed with Excel 2016 for chi-square p value estimates and linear regression modelling as appropriate...
June 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28538107/local-anesthetics-systemic-toxicity-association-with-exparel-bupivacaine-liposome-a-pharmacovigilance-evaluation
#16
Nitish Aggarwal
BACKGROUND: Local anesthetic systemic toxicity (last) is a rare life threatening complication usually from intra-arterial or intravenous injection leading to systemic absorption of regional anesthesia drug. the objective of this research was to statistically quantify the association between exparel (bupivacaine liposome) injectable suspension and last. METHODS: Adverse Event Reporting System database of FDA, which houses public and industry submitted adverse event case reports, was queried and analyzed to quantify the passive pharmacovigilance signal for Local Anesthetic Systemic Toxicity as associated with use of bupivacaine Liposome...
June 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28538105/linezolid-induced-lactic-acidosis-the-thin-line-between-bacterial-and-mitochondrial-ribosomes
#17
Alessandro Santini, Dario Ronchi, Manuela Garbellini, Daniela Piga, Alessandro Protti
Linezolid inhibits bacterial growth by targeting bacterial ribosomes and by interfering with bacterial protein synthesis. Lactic acidosis is a rare, but potentially lethal, side effect of linezolid. Areas covered: The pathogenesis of linezolid-induced lactic acidosis is reviewed with special emphasis on aspects relevant to the recognition, prevention and treatment of the syndrome. Expert opinion: Linezolid-induced lactic acidosis reflects the untoward interaction between the drug and mitochondrial ribosomes...
June 1, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28494654/new-formulations-of-tacrolimus-and-prevention-of-acute-and-chronic-rejections-in-adult-kidney-transplant-recipients
#18
Thomas Jouve, Lionel Rostaing, Paolo Malvezzi
​Introduction: As tolerance is not yet achievable, the kidney-transplanted-patients have to take on a daily-basis immunosuppressive drugs in order to avoid acute rejection-AR-. The cornerstone of immunosuppression relies on tacrolimus-therapy which is potentially nephrotoxic. Areas Covered: We identified from the studies published in the recent years those who were reporting on AR in de novo kidney-transplant recipients under tacrolimus-based therapy, as well as those who reported on the attempt to minimize tacrolimus-therapy...
May 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28504555/frequency-and-characteristics-of-infusion-reactions-during-biosimilar-infliximab-treatment-in-inflammatory-bowel-diseases-results-from-central-european-nationwide-cohort
#19
Anita Bálint, Mariann Rutka, Zsuzsanna Végh, Zsuzsanna Kürti, Krisztina B Gecse, János Banai, László Bene, Beáta Gasztonyi, Tünde Kristóf, László Lakatos, Pál Miheller, Károly Palatka, Árpád Patai, Ágnes Salamon, Tamás Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Renáta Bor, Ágnes Milassin, Anna Fábián, Ferenc Nagy, Martin Kolar, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukas, Péter L Lakatos, Tamás Molnár, Klaudia Farkas
BACKGROUND: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. METHODS: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically...
May 26, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28535693/experience-with-sunitinib-in-metastatic-renal-cell-carcinoma-mrcc-patients-pooled-analysis-from-3-spanish-observational-prospective-studies
#20
Daniel Castellano, José Pablo Maroto, Enrique Espinosa, Enrique Grande, Victoria Bolos, Julia Linares, Emilio Esteban, Aranzazu Gonzalez Del Alba, M A Climent, J A Arranz, Mª José Méndez, Eva Fernadez Parra, Luis Antón-Aparicio, Cristina Bayona, Isabel Gallegos, Enrique Gallardo, Luz Samaniego, J Garcia Donas
BACKGROUND: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon-α in metastatic renal cell carcinoma (mRCC) patients. OBJECTIVE: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice. METHODS: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals...
May 24, 2017: Expert Opinion on Drug Safety
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