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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/28439716/antipsychotic-prescribing-to-patients-diagnosed-with-dementia-without-a-diagnosis-of-psychosis-in-the-context-of-national-guidance-and-drug-safety-warnings-longitudinal-study-in-uk-general-practice
#1
S Jill Stocks, Evangelos Kontopantelis, Roger T Webb, Anthony J Avery, Alistair Burns, Darren M Ashcroft
INTRODUCTION: Policy interventions to address inappropriate prescribing of antipsychotic drugs to older people diagnosed with dementia are commonplace. In the UK, warnings were issued by the Medicines Healthcare products Regulatory Agency in 2004, 2009 and 2012 and the National Institute for Health and Care Excellence guidance was published in 2006. It is important to evaluate the impact of such interventions. METHODS: We analysed routinely collected primary-care data from 111,346 patients attending one of 689 general practices contributing to the Clinical Practice Research Datalink to describe the temporal changes in the prescribing of antipsychotic drugs to patients aged 65 years or over diagnosed with dementia without a concomitant psychosis diagnosis from 2001 to 2014 using an interrupted time series and a before-and-after design...
April 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28425072/comment-on-evaluation-of-facebook-and-twitter-monitoring-to-detect-safety-signals-for-medical-products-an-analysis-of-recent-fda-safety-alerts
#2
LETTER
Viroj Wiwanitkit
No abstract text is available yet for this article.
April 19, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28421551/macrolides-digoxin-toxicity-and-the-risk-of-sudden-death-a-population-based-study
#3
Kieran L Quinn, Erin M Macdonald, Tara Gomes, Muhammad M Mamdani, Anjie Huang, David N Juurlink
INTRODUCTION: Digoxin is commonly prescribed to elderly patients with heart failure and atrial fibrillation, and macrolide antibiotics markedly increase the risk of digoxin toxicity. OBJECTIVE: The aim was to determine whether, in older patients receiving digoxin, macrolide antibiotics are associated with sudden death. METHODS: We used a population-based, nested, case-control design from January 1, 1994 to December 31, 2012 in a cohort of Ontario residents aged 66 years or older prescribed digoxin...
April 18, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28417321/adjuvanted-as03-a-h1n1-2009-pandemic-influenza-vaccines-and-solid-organ-transplant-rejection-systematic-signal-evaluation-and-lessons-learnt
#4
Gaël Dos Santos, Harry A Seifert, Vincent Bauchau, Vivek Shinde, Dominique M Barbeau, Catherine Cohet
INTRODUCTION: We investigated a signal of solid organ transplant (SOT) rejection after immunisation with (AS03) A/H1N1 2009 pandemic influenza vaccines. METHODS: Potential immunological mechanisms were reviewed and quantitative analyses were conducted. The feasibility of pharmacoepidemiological studies was explored. RESULTS: Overall results, including data from a pharmacoepidemiological study, support the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients...
April 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28417320/patient-reporting-in-the-eu-analysis-of-eudravigilance-data
#5
Marin Banovac, Gianmario Candore, Jim Slattery, Francois Houÿez, David Haerry, Georgy Genov, Peter Arlett
INTRODUCTION: New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received from patients. OBJECTIVES: This descriptive study aims to provide insight into patient reporting for the totality of the EU by querying the EudraVigilance (EV) database for the period of 3 years before the new pharmacovigilance legislation became operational and the 3 years after as well as comparing patient reports with those from healthcare professionals (HCPs) where feasible...
April 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28405899/the-quality-of-clinical-information-in-adverse-drug-reaction-reports-by-patients-and-healthcare-professionals-a-retrospective-comparative-analysis
#6
Leàn Rolfes, Florence van Hunsel, Laura van der Linden, Katja Taxis, Eugène van Puijenbroek
INTRODUCTION: Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. OBJECTIVE: The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. METHODS: A retrospective analysis of all ADR reports on the same case, i...
April 12, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28397186/managing-cardiovascular-risk-of-macrolides-systematic-review-and-meta-analysis
#7
REVIEW
Angel Y S Wong, Esther W Chan, Shweta Anand, Alan J Worsley, Ian C K Wong
INTRODUCTION: It was postulated that antibiotics including macrolides could be used for the secondary prevention of coronary heart disease but recent studies showed that macrolides increase the cardiovascular risk. We aimed to review the evidence of cardiovascular risk associated with macrolides regarding duration of effect and risk factors; and to explore the potential effect of statins for the prevention of cardiovascular events as a result of macrolide use. METHODS: Several electronic databases (PubMed, EMBASE, Cochrane library) were searched to identify eligible studies...
April 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28389980/drug-induced-arrhythmia-bridging-the-gap-between-pathophysiological-knowledge-and-clinical-practice
#8
LETTER
Elisabetta Poluzzi, Emanuel Raschi, Igor Diemberger, Fabrizio De Ponti
No abstract text is available yet for this article.
April 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28389979/species-adulteration-in-the-herbal-trade-causes-consequences-and-mitigation
#9
REVIEW
Ramanujam Srirama, J U Santhosh Kumar, G S Seethapathy, Steven G Newmaster, S Ragupathy, K N Ganeshaiah, R Uma Shaanker, Gudasalamani Ravikanth
The global economy of the international trade of herbal products has been increasing by 15% annually, with the raw material for most herbal products being sourced from South and Southeast Asian countries. In India, of the 8000 species of medicinal plants harvested from the wild, approximately 960 are in the active trade. With increasing international trade in herbal medicinal products, there is also increasing concern about the widespread adulteration and species admixtures in the raw herbal trade. The adverse consequences of such species adulteration on the health and safety of consumers have only recently begun to be recognised and documented...
April 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28382494/adverse-drug-reaction-related-hospitalizations-in-elderly-australians-a-prospective-cross-sectional-study-in-two-tasmanian-hospitals
#10
Nibu Parameswaran Nair, Leanne Chalmers, Bonnie J Bereznicki, Colin Curtain, Gregory M Peterson, Michael Connolly, Luke R Bereznicki
INTRODUCTION: Adverse drug reactions (ADRs) have been commonly cited as a major cause of hospital admissions in older individuals. However, despite the apparent magnitude of this problem, there are limited prospective data on ADRs as a cause of hospitalization in elderly medical patients. OBJECTIVES: The objective of this study was to evaluate the proportion, clinical characteristics, causality, severity, preventability, and outcome of ADR-related admissions in older patients admitted to two Tasmanian hospitals...
April 6, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28382493/drospirenone-containing-oral-contraceptive-pills-and-the-risk-of-venous-thromboembolism-an-assessment-of-risk-in-first-time-users-and-restarters
#11
Natasha Larivée, Samy Suissa, Janie Coulombe, Vicky Tagalakis, Kristian B Filion
INTRODUCTION: The effects of drospirenone-containing combined oral contraceptives (COCs) on the risk of venous thromboembolism (VTE) remain controversial due to the challenge in distinguishing between first-time users and restarters, and their different underlying VTE risks, in healthcare databases. OBJECTIVES: The aim of this study was to describe the challenge of studying the risk of VTE among first-time users of drospirenone-containing COCs in a healthcare database and assess the risk among first-time users and restarters...
April 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28361405/impact-of-safety-related-regulations-on-codeine-use-in-children-a-quasi-experimental-study-using-taiwan-s-national-health-insurance-research-database
#12
Chih-Wan Lin, Ching-Huan Wang, Wei-I Huang, Wei-Ming Ke, Pi-Hui Chao, Wen-Wen Chen, Fei-Yuan Hsiao
INTRODUCTION: Safety concerns regarding potential life-threatening adverse events associated with codeine have resulted in policy decisions to restrict its use in pediatrics. However, whether these drug safety communications have had an immediate and strong impact on codeine use remains in question. OBJECTIVE: We aimed to investigate the impact of the two implemented safety-related regulations (label changes and reimbursement regulations) on the use of codeine for upper respiratory infection (URI) or cough...
March 30, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28342075/evaluation-of-pre-marketing-factors-to-predict-post-marketing-boxed-warnings-and-safety-withdrawals
#13
Andreas Schick, Kathleen L Miller, Michael Lanthier, Gerald Dal Pan, Clark Nardinelli
INTRODUCTION: An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28342074/evaluation-of-saefvic-a-pharmacovigilance-surveillance-scheme-for-the-spontaneous-reporting-of-adverse-events-following-immunisation-in-victoria-australia
#14
Hazel J Clothier, Nigel W Crawford, Melissa Russell, Heath Kelly, Jim P Buttery
INTRODUCTION: Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community)...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28321782/targeting-interleukin-5-or-interleukin-5r%C3%AE-safety-considerations
#15
REVIEW
Diego Bagnasco, Matteo Ferrando, Marco Caminati, Alice Bragantini, Francesca Puggioni, Gilda Varricchi, Giovanni Passalacqua, Giorgio Walter Canonica
Asthma is a highly prevalent chronic disease of the airways; approximately 10% of patients with asthma will experience a severe form of the disease. New understanding of the pathogenesis of asthma has enabled the development of novel drugs and provided hope for patients with asthma. Interleukin (IL)-5 and IL-5 receptor subunit α (IL-5-Rα) plays a crucial role in the development, maturation, and operation of eosinophils so were the first important therapeutic target of these new drugs. While the results of early clinical trials of these drugs were not promising, results improved once researchers discovered the drugs worked best in patients with high eosinophil levels...
March 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28315139/medicines-save-medicines-kill
#16
LETTER
Joel Lexchin
No abstract text is available yet for this article.
March 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28299611/summarising-the-evidence-for-drug-safety-a-methodological-discussion-of-different-meta-analysis-approaches
#17
Guillermo Prada-Ramallal, Bahi Takkouche, Adolfo Figueiras
Evidence on drug safety obtained from randomised clinical trials is very limited due to, among other reasons, their relatively small sample size. Hence, combining the results of available studies can prove particularly useful. This paper reviews the different data sources for summarising drug safety outcomes, according to study design, publication of data, and origin of the information. It then discusses the various types of overviews that can be used in the study of treatment harms, focusing on meta-analyses of aggregate data and meta-analyses of individual patient data, with their advantages and drawbacks, such as publication bias and heterogeneity...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28299610/pharmacovigilance-of-regenerative-medicine-under-the-amended-pharmaceutical-affairs-act-in-japan
#18
Yasuko Inokuma
Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28293864/using-probabilistic-record-linkage-of-structured-and-unstructured-data-to-identify-duplicate-cases-in-spontaneous-adverse-event-reporting-systems
#19
Kory Kreimeyer, David Menschik, Scott Winiecki, Wendy Paul, Faith Barash, Emily Jane Woo, Meghna Alimchandani, Deepa Arya, Craig Zinderman, Richard Forshee, Taxiarchis Botsis
INTRODUCTION: Duplicate case reports in spontaneous adverse event reporting systems pose a challenge for medical reviewers to efficiently perform individual and aggregate safety analyses. Duplicate cases can bias data mining by generating spurious signals of disproportional reporting of product-adverse event pairs. OBJECTIVE: We have developed a probabilistic record linkage algorithm for identifying duplicate cases in the US Vaccine Adverse Event Reporting System (VAERS) and the US Food and Drug Administration Adverse Event Reporting System (FAERS)...
March 14, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28275963/adverse-drug-event-causality-analysis-adeca-a-process-for-evaluating-evidence-and-assigning-drugs-to-risk-categories-for-sudden-death
#20
Raymond L Woosley, Klaus Romero, Craig W Heise, Tyler Gallo, Jared Tate, Raymond David Woosley, Sophie Ward
Growing evidence indicates that many drugs have the ability to cause a potentially lethal cardiac arrhythmia, torsades de pointes (TdP). This necessitates the development of a compilation of drugs that have this potential toxicity. Such a list is helpful in identifying the etiology of TdP in patients taking multiple drugs and assists decision making by those caring for patients at high risk of TdP. The Arizona Center for Education and Research on Therapeutics (AZCERT) has developed a process to standardize the identification of drugs and place them in risk categories for their clinical ability to cause TdP and QT prolongation...
March 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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