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Pharmacovigilance

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https://www.readbyqxmd.com/read/28538107/local-anesthetics-systemic-toxicity-association-with-exparel-bupivacaine-liposome-a-pharmacovigilance-evaluation
#1
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/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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
https://www.readbyqxmd.com/read/28477160/current-status-of-biosimilars-in-oncology
#16
REVIEW
Luis H Camacho
Four medicinal cancer biological blockbusters will end their patent lifespan by 2020. It is estimated that the total market for cancer biologicals will reach approximately US$68 billion at that time. Approximately 20 biosimilars have entered the European market since the launch of the original approval guidelines in 2005, and four biosimilars have been approved in the USA since 2015. Data from European countries with the highest market entrance of biosimilars suggest that the incorporation of biosimilars into healthcare systems worldwide may result in a 30-45% cost savings...
June 2017: Drugs
https://www.readbyqxmd.com/read/28469434/analysis-of-individual-differences-in-vaccine-pharmacovigilance-using-vaers-data-and-meddra-system-organ-classes-a-use-case-study-with-trivalent-influenza-vaccine
#17
Jingcheng Du, Yi Cai, Yong Chen, Yongqun He, Cui Tao
Personalized and precision vaccination requires consideration of an individual's sex and age. This article proposed systematic methods to study individual differences in adverse reactions following vaccination and chose trivalent influenza vaccine as a use case. Data were extracted from the Vaccine Adverse Event Reporting System from years 1990 to 2014. We first grouped symptoms into the Medical Dictionary for Regulatory Activities System Organ Classes (SOCs). We then applied zero-truncated Poisson regression and logistic regression to identify reporting differences among different individual groups over the SOCs...
2017: Biomedical Informatics Insights
https://www.readbyqxmd.com/read/28468748/twimed-twitter-and-pubmed-comparable-corpus-of-drugs-diseases-symptoms-and-their-relations
#18
Nestor Alvaro, Yusuke Miyao, Nigel Collier
BACKGROUND: Work on pharmacovigilance systems using texts from PubMed and Twitter typically target at different elements and use different annotation guidelines resulting in a scenario where there is no comparable set of documents from both Twitter and PubMed annotated in the same manner. OBJECTIVE: This study aimed to provide a comparable corpus of texts from PubMed and Twitter that can be used to study drug reports from these two sources of information, allowing researchers in the area of pharmacovigilance using natural language processing (NLP) to perform experiments to better understand the similarities and differences between drug reports in Twitter and PubMed...
May 3, 2017: JMIR Public Health and Surveillance
https://www.readbyqxmd.com/read/28462545/indian-college-of-physicians-icp-position-statement-on-pharmacovigilance
#19
Puneet Dhamija, Sanjay Kalra, Pramod Kumar Sharma, V Kalaiselvan, A Muruganathan, Yatan Pal Singh Balhara, Rajesh Badani, Ganapathi Bantwal, A K Das, Bharati Dhorepatil, Sujoy Ghosh, Tarun Jeloka, Deepak Khandelwal, Milind Y Nadkar, Kuppili Pooja Patnaik, Banshi Saboo, Manisha Sahay, Rakesh Sahay, Mangesh Tiwaskar, A G Unnikrishnan
Pharmacovigilance is the art and science of detection, understanding and prevention of adverse drug reactions and not merely a critical analysis of prescriptions and errors. This field starts with reporting by clinicians of a suspected adverse drug reaction (ADR) to the pharmacologist followed by joint causality analysis and ends at the application of new information by a clinician for benefit of patients. There are a number of ways, which can be utilised for reporting adverse effects using pen and paper format to software applications for smart phones...
March 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28461037/post-marketing-drug-withdrawals-pharmacovigilance-success-regulatory-problems
#20
Jeffrey K Aronson
Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence...
March 30, 2017: Thérapie
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