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Pharmacovigilence

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https://www.readbyqxmd.com/read/28544026/immobilization-and-high-platelet-count-are-associated-with-thromboembolic-complications-in-heparin-induced-thrombocytopenia
#1
Juliane Bolbrinker, Edeltraut Garbe, Antonios Douros, Matthias Huber, Elisabeth Bronder, Andreas Klimpel, Frank Andersohn, Oliver Meyer, Abdulgabar Salama, Reinhold Kreutz
PURPOSE: Immune-mediated heparin-induced thrombocytopenia (HIT type II, HIT) is a potentially serious adverse drug reaction characterized by an increased risk of venous and arterial thrombosis. This study aimed to identify risk factors associated with the development of these complications. METHODS: Our study cohort included patients with HIT assembled in our pharmacovigilance center by reports from 51 collaborating hospitals in Berlin, Germany. To identify risk factors for thromboembolic complications, patients with thromboembolic events (cases) were compared to those without thromboembolic events (controls) in a case-control design...
May 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28540760/biologicals-and-biosimilars-safety-issues-in-europe
#2
Maria da Conceição Constantino Portela, Carlos Sinogas, Fernando Albuquerque de Almeida, Ricardo Baptista-Leite, Alexandre Castro-Caldas
Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution...
May 25, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28540672/communication-on-safety-of-medicines-in-europe-current-practices-and-general-practitioners-awareness-and-preferences
#3
Sieta T de Vries, Maartje J M van der Sar, Amelia Cupelli, Ilaria Baldelli, Anna Marie Coleman, Dolores Montero, Ivana Šipić, Adriana Andrić, Annika Wennberg, Jane Ahlqvist-Rastad, Petra Denig, Peter G M Mol
INTRODUCTION: National competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs). OBJECTIVE: The aim of this study was to assess current European NCA safety communication practices and to investigate European GPs' awareness of and preferences for safety communications on medicines...
May 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28538107/local-anesthetics-systemic-toxicity-association-with-exparel-bupivacaine-liposome-a-pharmacovigilance-evaluation
#4
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...
May 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28536921/progressive-multifocal-leukoencephalopathy-in-patients-treated-with-fumaric-acid-esters-a-review-of-19-cases
#5
Robbert-Jan Gieselbach, Annemarie H Muller-Hansma, Martijn T Wijburg, Marjolein S de Bruin-Weller, Bob W van Oosten, Dennis J Nieuwkamp, Frank E Coenjaerts, Mike P Wattjes, Jean-Luc Murk
Progressive multifocal leukoencephalopathy (PML) is a rare and potentially fatal condition caused by a brain infection with JC polyomavirus (JCV). PML develops almost exclusively in immunocompromised patients and has recently been associated with use of fumaric acid esters (FAEs), or fumarates. We reviewed the literature and the Dutch and European pharmacovigilance databases in order to identify all available FAE-associated PML cases and distinguish possible common features among these patients. A total of 19 PML cases associated with FAE use were identified...
May 23, 2017: Journal of Neurology
https://www.readbyqxmd.com/read/28535793/intermittent-preventive-treatment-for-malaria-among-children-in-a-refugee-camp-in-northern-uganda-lessons-learned
#6
Matthew E Coldiron, Estrella Lasry, Malika Bouhenia, Debashish Das, Peter Okui, Dan Nyehangane, Juliet Mwanga, Celine Langendorf, Greg Elder, Léon Salumu, Rebecca F Grais
Northern Uganda hosts a large population of refugees from South Sudan, and malaria is one of the major health problems in the area. In 2015, intermittent preventive treatment for malaria (IPTc) was implemented in two refugee camps among children aged 6 months to 14 years. Three distributions of dihydroartemisinin-piperaquine (DP) were conducted at 8-week intervals. The first dose was directly administered at IPTc distribution sites and the second and third doses were given to caregivers to administer at home...
May 23, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28533699/comparative-analysis-of-the-safety-and-tolerability-of-fixed-dose-artesunate-amodiaquine-versus-artemether-lumefantrine-combinations-for-uncomplicated-falciparum-malaria-in-pregnancy-a-randomized-open-label-study
#7
Osede I Iribhogbe, Igue Emmanuel, Marylove Odianosen
A comparative clinical study was conducted to evaluate the safety and tolerability of two commonly used fixed dose artemisinin-based combinations for the treatment of uncomplicated Plasmodium falciparum malaria in the second and third trimester of pregnancy. To achieve this, a total of 155 participants were recruited for the study. Eighty of these were drawn from pregnant women who came for routine antenatal care while 40 nonpregnant participants were recruited from apparently healthy females in the community...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28533329/pregnancy-outcome-after-first-trimester-use-of-methyldopa-a-prospective-cohort-study
#8
Maria Hoeltzenbein, Evelin Beck, Anne-Katrin Fietz, Juliane Wernicke, Sandra Zinke, Angela Kayser, Stephanie Padberg, Corinna Weber-Schoendorfer, Reinhard Meister, Christof Schaefer
Published experience on first trimester exposure to methyldopa is still limited, although it is recommended as first-line treatment for hypertensive disorders in pregnancy in most countries. The primary aim of this prospective observational cohort study was to analyze the rate of major birth defects and spontaneous abortions in women with methyldopa therapy for chronic hypertension. Outcomes of 261 pregnancies with first trimester exposure to methyldopa and 526 comparison pregnancies without chronic hypertension reported to the German Embryotox pharmacovigilance institute were evaluated...
May 22, 2017: Hypertension
https://www.readbyqxmd.com/read/28532202/experiences-of-establishing-an-academic-early-phase-clinical-trials-unit
#9
Sarah R Brown, Debbie Sherratt, Gill Booth, Julia Brown, Fiona Collinson, Walter Gregory, Louise Flanagan
BACKGROUND: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two. There is pressure to perform these trials quickly, safely, and robustly. However, there are inherent differences between developing and managing early phase, compared to late phase, drug trials. This article describes an approach to establishing an academically led early phase trial portfolio, highlighting lessons learned and sharing experiences...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28524293/the-contribution-of-direct-patient-reported-adrs-to-drug-safety-signals-in-the-netherlands-from-2010-to-2015
#10
Florence van Hunsel, Susan de Waal, Linda Härmark
PURPOSE: The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. METHOD: All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports...
May 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28522742/evaluation-of-radiopharmaceutical-adverse-reaction-reports-to-the-british-nuclear-medicine-society-for-the-period-2007-to-2016
#11
Tracia-Gay Kennedy-Dixon, Maxine Gossell-Williams, Margaret Cooper, Moez Trabelsi, Sobhan Vinjamuri
Objective: This study sought to answer the calls for the restoration of reports of adverse reactions from the European Association of Nuclear Medicine. It assessed reports of adverse reactions to radiopharmaceuticals (ARRPs) that were submitted to the British Nuclear Medicine Society's (BNMS) Radiopharmaceutical Adverse Reactions and Product Defects online database during the period January 2007 to December 2016. Methodology: This investigation was a pharmacovigilance based, non-experimental, cross-sectional study aimed at finding the prevalence and association between radiopharmaceuticals and adverse reactions...
May 18, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/28517913/sodium-glucose-co-transporter-2-inhibitors-and-diabetic-ketoacidosis-an-updated-review-of-the-literature
#12
REVIEW
Benedetta Maria Bonora, Angelo Avogaro, Gian Paolo Fadini
AIMS: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are increasingly used for the treatment of type 2 diabetes (T2D) and can improve glucose control also in type 1 diabetes (T1D). In May 2015, regulatory agencies issued a warning that SGLT2i may cause diabetic ketoacidosis (DKA). We report details on two new cases of SGLT2i-associated DKA and review the literature for similar cases within randomised controlled trials (RCTs), cohort studies, and single reports. METHODS: We searched the medical literature for reports of SGLT2i-associated DKA cases...
May 18, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28511659/antiplasmodial-activity-of-indigofera-spicata-root-extract-against-plasmodium-berghei-infection-in-mice
#13
Eshetie Melese Birru, Mestayet Geta, Abyot Endale Gurmu
BACKGROUND: In addition to pharmacovigilance and pharmaco-economic concerns, resistance to anti-malarial medicines has been documented in all classes of anti-malarials and this is further worsened by resistance to common insecticides by malaria vector, which is a major threat to malaria control. As a means of facing the challenges of searching for new anti-malarial agents, the current study focused on evaluation of anti-malarial activity of root extract of Indigofera spicata. METHODS: Chloroquine-sensitive rodent malaria parasite, Plasmodium berghei (ANKA strain) was used to infect the Swiss Albino mice in 4-day suppressive and curative models...
May 16, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28508325/preliminary-results-of-a-novel-algorithmic-method-aiming-to-support-initial-causality-assessment-of-routine-pharmacovigilance-case-reports-for-medication-induced-liver-injury-the-pv-rucam
#14
Erik Scalfaro, Henk Johan Streefkerk, Michael Merz, Christoph Meier, David Lewis
INTRODUCTION: Data incompleteness in pharmacovigilance (PV) health records limits the use of current causality assessment methods for drug-induced liver injury (DILI). In addition to the inherent complexity of this adverse event, identifying cases of high causal probability is difficult. OBJECTIVE: The aim was to evaluate the performance of an improved, algorithmic and standardised method called the Pharmacovigilance-Roussel Uclaf Causality Assessment Method (PV-RUCAM), to support assessment of suspected DILI...
May 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28505618/use-of-epinephrine-in-patients-with-drug-induced-anaphylaxis-an-analysis-of-the-beijing-pharmacovigilance-database
#15
Tiansheng Wang, Xiang Ma, Yan Xing, Shusen Sun, Hua Zhang, Til Stürmer, Bin Wang, Xiaotong Li, Huilin Tang, Ligong Jiao, Suodi Zhai
BACKGROUND: Few studies assessing the use of epinephrine in drug-induced anaphylaxis (DIA) in the hospital setting are available. We utilized the Beijing Pharmacovigilance Database (BPD) to evaluate the appropriateness of epinephrine for DIA management. METHODS: DIA cases collected in the BPD from January 2004 to December 2014 were adjudicated and analyzed for demographics, causative drugs, clinical signs, outcomes, initial treatment, route, dosing, and cardiovascular adverse events (CAE) of epinephrine...
May 16, 2017: International Archives of Allergy and Immunology
https://www.readbyqxmd.com/read/28505041/the-potential-return-on-public-investment-in-detecting-adverse-drug-effects
#16
Krista F Huybrechts, Rishi J Desai, Moa Park, Joshua J Gagne, Mehdi Najafzadeh, Jerry Avorn
BACKGROUND: Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. OBJECTIVE: Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. RESEARCH DESIGN: We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available...
June 2017: Medical Care
https://www.readbyqxmd.com/read/28500776/analysis-of-national-pharmacovigilance-data-associated-with-statin-use-in-korea-adverse-drug-reactions-with-statins
#17
Hyunah Kim, Namhyo Kim, Da Hee Lee, Hun-Sung Kim
The aim of this study was to evaluate clinical manifestations, age distribution and risk factors of adverse drug reactions (ADRs) of statins. Korean Adverse Event Reporting System (KAERS) database records (July 2009 - June 2014) on statin-treated adults were used. ADRs classified as "certain," "probable" and "possible" based on the WHO-Uppsala Monitoring Centre criteria were analysed. The frequency of ADRs was compared between adults (18-64 years) and older people (age ≥ 65 years) groups. In total, 2161 ADRs from 1690 patients (579, 34...
May 13, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28500154/suspected-adverse-events-2015
#18
S Cooles, G Diesel, J Blenkinsop
The following article has been produced by the pharmacovigilance unit at the Veterinary Medicines Directorate (VMD) to provide a summary of some of the results from its surveillance work carried out in 2015Decrease in number of reports for food-producing speciesIncrease in number of pet animal reportsReports of dogs affected by medicines intended for large animals.
May 13, 2017: Veterinary Record
https://www.readbyqxmd.com/read/28495807/neurologic-serious-adverse-events-associated-with-nivolumab-plus-ipilimumab-or-nivolumab-alone-in-advanced-melanoma-including-a-case-series-of-encephalitis
#19
James Larkin, Bartosz Chmielowski, Christopher D Lao, F Stephen Hodi, William Sharfman, Jeffrey Weber, Karijn P M Suijkerbuijk, Sergio Azevedo, Hewei Li, Daniel Reshef, Alexandre Avila, David A Reardon
BACKGROUND: Despite unprecedented efficacy across multiple tumor types, immune checkpoint inhibitor therapy is associated with a unique and wide spectrum of immune-related adverse events (irAEs), including neurologic events ranging from mild headache to potentially life-threatening encephalitis. Here, we summarize neurologic irAEs associated with nivolumab and ipilimumab melanoma treatment, present cases of treatment-related encephalitis, and provide practical guidance on diagnosis and management...
May 11, 2017: Oncologist
https://www.readbyqxmd.com/read/28480041/risk-of-qt-prolongation-and-torsade-de-pointes-associated-with-exposure-to-hydroxyzine-re-evaluation-of-an-established-drug
#20
Anne-Françoise Schlit, Annie Delaunois, Aurore Colomar, Branderley Claudio, Luca Cariolato, Rossen Boev, Jean-Pierre Valentin, Christopher Peters, Victor S Sloan, Jürgen W G Bentz
Several noncardiac drugs have been linked to cardiac safety concerns, highlighting the importance of post-marketing surveillance and continued evaluation of the benefit-risk of long-established drugs. Here, we examine the risk of QT prolongation and/or torsade de pointes (TdP) associated with the use of hydroxyzine, a first generation sedating antihistamine. We have used a combined methodological approach to re-evaluate the cardiac safety profile of hydroxyzine, including: (1) a full review of the sponsor pharmacovigilance safety database to examine real-world data on the risk of QT prolongation and/or TdP associated with hydroxyzine use and (2) nonclinical electrophysiological studies to examine concentration-dependent effects of hydroxyzine on a range of human cardiac ion channels...
June 2017: Pharmacology Research & Perspectives
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