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

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https://read.qxmd.com/read/30972641/benefit-risk-assessment-of-obesity-drugs-focus-on-glucagon-like-peptide-1-receptor-agonists
#1
REVIEW
Rasmus M Christensen, Christian R Juhl, Signe S Torekov
The prevalence of obesity and related comorbidities is increasing worldwide. Furthermore,  clinically meaningful body weight losses has proven difficult to achieve and especially to maintain through sustained lifestyle change in the form of diet and exercise. Pharmacotherapy against obesity is a non-invasive treatment as an adjunct to lifestyle changes, but approved anti-obesity drugs are currently few. This article reviews the major anti-obesity drugs and the benefit-risk profiles of the long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RAs) liraglutide and semaglutide (a modified version of liraglutide with longer half-life and tripled receptor affinity)...
April 10, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30972640/long-term-safety-and-efficacy-of-fecal-microbiota-transplant-in-active-ulcerative-colitis
#2
Xiao Ding, Qianqian Li, Pan Li, Ting Zhang, Bota Cui, Guozhong Ji, Xiang Lu, Faming Zhang
INTRODUCTION AND OBJECTIVE: The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS: Two clinical trials (NCT01790061, NCT02560727) for moderate-to-severe ulcerative colitis (Mayo score range 6-12) were performed from November 2012 to July 2017. Both studies were pooled for analysis on the safety and efficacy of fecal microbiota transplantation in patients with ulcerative colitis over a 1-year follow-up...
April 10, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30963449/correction-to-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
#3
S Jill Stocks, Evangelos Kontopantelis, Roger T Webb, Anthony J Avery, Alistair Burns, Darren M Ashcroft
This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License.
April 8, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30937852/comment-on-evaluation-of-the-reported-rates-of-severe-hypersensitivity-reactions-associated-with-ferric-carboxymaltose-and-iron-iii-isomaltoside-1000-in-europe-based-on-data-from-eudravigilance-and-vigibase%C3%A2-between-2014-and-2017
#4
LETTER
Philip Schaffalitzky de Muckadell, Claes Christian Strom
No abstract text is available yet for this article.
April 1, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30937851/authors-reply-to-schaffalitzky-de-muckadell-and-colleague-s-comment-on-evaluation-of-the-reported-rates-of-severe-hypersensitivity-reactions-associated-with-ferric-carboxymaltose-and-iron-iii-isomaltoside-1000-in-europe-based-on-data-from-eudravigilance-and
#5
LETTER
Birgit Ehlken, Lennart Nathell, Annegret Gohlke, Derya Bocuk, Massoud Toussi, Stefan Wohlfeil
No abstract text is available yet for this article.
April 1, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30929141/establishing-a-framework-for-the-use-of-social-media-in-pharmacovigilance-in-europe
#6
Sabine Brosch, Anne-Marie de Ferran, Victoria Newbould, Diane Farkas, Marina Lengsavath, Phil Tregunno
The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance...
March 30, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30911975/recommendations-on-the-use-of-mobile-applications-for-the-collection-and-communication-of-pharmaceutical-product-safety-information-lessons-from-imi-web-radr
#7
Carrie E Pierce, Sieta T de Vries, Stephanie Bodin-Parssinen, Linda Härmark, Phil Tregunno, David J Lewis, Simon Maskell, Raphael Van Eemeren, Alicia Ptaszynska-Neophytou, Victoria Newbould, Nabarun Dasgupta, Antoni F Z Wisniewski, Sara Gama, Peter G M Mol
Over a period of 3 years, the European Union's Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety...
March 25, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30911974/correction-to-vigigrade-a-tool-to-identify-well-documented-individual-case-reports-and-highlight-systematic-data-quality-issues
#8
Tomas Bergvall, G Niklas Norén, Marie Lindquist
The article "vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues".
March 25, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30888626/drug-induced-photosensitivity-an-update-culprit-drugs-prevention-and-management
#9
REVIEW
Kim M Blakely, Aaron M Drucker, Cheryl F Rosen
Photosensitive drug eruptions are cutaneous adverse events due to exposure to a medication and either ultraviolet or visible radiation. In this review, the diagnosis, prevention and management of drug-induced photosensitivity is discussed. Diagnosis is based largely on the history of drug intake and the appearance of the eruption primarily affecting sun-exposed areas of the skin. This diagnosis can also be aided by tools such as phototesting, photopatch testing and rechallenge testing. The mainstay of management is prevention, including informing patients of the possibility of increased photosensitivity as well as the use of appropriate sun protective measures...
March 19, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30888625/summary-of-torsades-de-pointes-tdp-reports-associated-with-intravenous-drug-formulations-containing-the-preservative-chlorobutanol
#10
R David Woosley, Klaus Romero, Craig W Heise, Tyler Gallo, Jared Tate, Raymond L Woosley
INTRODUCTION: Drug-induced torsades de pointes (TdP) is a potentially lethal ventricular arrhythmia that is associated with drugs that prolong the QT interval on the electrocardiogram (ECG) due to their interference with the cardiac potassium current, IKR . Intravenous (IV) formulations of methadone have been associated with TdP and contain the preservative chlorobutanol, which, like methadone, blocks IKR . The combinations of chlorobutanol with methadone or terfenadine, another IKR blocker, produce synergistic IKR block...
March 19, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30868436/sirolimus-and-mtor-inhibitors-a-review-of-side-effects-and-specific-management-in-solid-organ-transplantation
#11
REVIEW
Lee S Nguyen, Mathieu Vautier, Yves Allenbach, Noel Zahr, Olivier Benveniste, Christian Funck-Brentano, Joe-Elie Salem
Inhibitors of mechanistic target of rapamycin (mTOR inhibitors) are used as antiproliferative immunosuppressive drugs and have many clinical applications in various drug combinations. Experience in transplantation studies has been gained regarding the side effect profile of these drugs and the potential benefits and limitations compared with other immunosuppressive agents. This article reviews the adverse effects of mTOR inhibitors in solid organ transplantation, with special attention given to mechanisms hypothesized to cause adverse events and their management strategies...
March 13, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30863920/correction-to-vigigrade-a-tool-to-identify-well-documented-individual-case-reports-and-highlight-systematic-data-quality-issues
#12
Tomas Bergvall, G Niklas Norén, Marie Lindquist
The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access.
March 12, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30852794/correction-to-implications-of-individual-qt-rr-profiles-part-1-inaccuracies-and-problems-of-population-specific-qt-heart-rate-corrections
#13
Marek Malik, Christine Garnett, Katerina Hnatkova, Jose Vicente, Lars Johannesen, Norman Stockbridge
The Open Access license, which previously read.
March 9, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30830573/benefit-risk-assessment-of-vedolizumab-in-the-treatment-of-crohn-s-disease-and-ulcerative-colitis
#14
REVIEW
Robert Battat, Christopher Ma, Vipul Jairath, Reena Khanna, Brian G Feagan
Vedolizumab, a humanized monoclonal antibody to the α4β7 integrin, reduces lymphocyte trafficking to the intestine. This gut-selective mechanism of action offers a safer alternative to other biologics used to treat ulcerative colitis (UC) and Crohn's disease (CD). We reviewed efficacy and safety data from randomized controlled trials (RCTs), open-label extension (OLE) and observational studies, and pooled analyses of vedolizumab therapy. In UC, RCTs demonstrate that vedolizumab is effective for induction and maintenance of remission, regardless of prior tumor necrosis factor (TNF) antagonist exposure...
March 4, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30830572/established-and-emerging-immunological-complications-of-biological-therapeutics-in-multiple-sclerosis
#15
REVIEW
Babak Soleimani, Katy Murray, David Hunt
Biologic immunotherapies have transformed the treatment landscape of multiple sclerosis. Such therapies include recombinant proteins (interferon beta), as well as monoclonal antibodies (natalizumab, alemtuzumab, daclizumab, rituximab and ocrelizumab). Monoclonal antibodies show particular efficacy in the treatment of the inflammatory phase of multiple sclerosis. However, the immunological perturbations caused by biologic therapies are associated with significant immunological adverse reactions. These include development of neutralising immunogenicity, secondary immunodeficiency and secondary autoimmunity...
March 4, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30762164/a-comparison-study-of-algorithms-to-detect-drug-adverse-event-associations-frequentist-bayesian-and-machine-learning-approaches
#16
Minh Pham, Feng Cheng, Kandethody Ramachandran
INTRODUCTION: It is important to monitor the safety profile of drugs, and mining for strong associations between drugs and adverse events is an effective and inexpensive method of post-marketing safety surveillance. OBJECTIVE: The objective of our work was to compare the accuracy of both common and innovative methods of data mining for pharmacovigilance purposes. METHODS: We used the reference standard provided by the Observational Medical Outcomes Partnership, which contains 398 drug-adverse event pairs (165 positive controls, 233 negative controls)...
February 14, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30762163/drug-induced-steatosis-and-steatohepatitis-the-search-for-novel-serum-biomarkers-among-potential-biomarkers-for-non-alcoholic-fatty-liver-disease-and-non-alcoholic-steatohepatitis
#17
REVIEW
Lauren Pavlik, Arie Regev, Paul A Ardayfio, Naga P Chalasani
Drug-induced steatosis (DIS) and drug-induced steatohepatitis (DISH) are two of several types of drug-induced liver injury (DILI). They can be caused by various drugs and may present as acute, potentially lethal disorders or as chronic slowly progressive liver injury. Despite the fact that they are distinct disorders, the slow progressive forms of DIS and DISH are often confused with or misdiagnosed as non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), which are much more common and, by definition, not caused by drugs...
February 14, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30739254/ustekinumab-safety-in-psoriasis-psoriatic-arthritis-and-crohn-s-disease-an-integrated-analysis-of-phase-ii-iii-clinical-development-programs
#18
Subrata Ghosh, Lianne S Gensler, Zijiang Yang, Chris Gasink, Soumya D Chakravarty, Kamyar Farahi, Paraneedharan Ramachandran, Elyssa Ott, Bruce E Strober
INTRODUCTION: Theoretical risks of biologic agents remain under study. OBJECTIVE: The aim of this study was to integrate 1-year safety data from 12 ustekinumab registrational trials. METHODS: Patients had moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) (± methotrexate), or moderate-to-severe Crohn's disease (CD; failed/intolerant of immunomodulators/corticosteroids). Psoriatic patients received subcutaneous ustekinumab 45/90 mg or placebo, generally at week 0, week 4, then every 12 weeks thereafter, while those with CD received a single intravenous ustekinumab dose (130 mg or weight range-based dosing of approximately 6 mg/kg) or placebo induction dose at week 0, followed by subcutaneous ustekinumab 90 mg at week 8 and every 8/12 weeks thereafter...
February 9, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30734242/use-of-fda-s-sentinel-system-to-quantify-seizure-risk-immediately-following-new-ranolazine-exposure
#19
Efe Eworuke, Emily C Welch, Anne Tobenkin, Judith C Maro
INTRODUCTION: Neurological complications including seizures have been reported with ranolazine. We sought to quantify the risk of seizure-related hospitalizations or emergency department events following ranolazine exposure in the Sentinel System (2006-2015). STUDY DESIGN AND SETTING: Eligibility criteria were new use of ranolazine after 183 days washout period and absence of seizure diagnoses, anti-epileptic drugs, or seizure-related disorders during the baseline period...
February 8, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30725337/use-of-a-patient-friendly-terms-list-in-the-adverse-drug-reaction-report-form-a-database-study
#20
Sieta T de Vries, Judy Harrison, Patrick Revelle, Alicia Ptaszynska-Neophytou, Anna Radecka, Gowthamei Ragunathan, Phil Tregunno, Petra Denig, Peter G M Mol
INTRODUCTION: When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions experienced in free-text format. Recently, a patient-friendly adverse drug reaction terms list was introduced in the adverse drug reaction report form in the UK to facilitate this reporting. OBJECTIVE: The objective of this study was to evaluate the actual use of the patient-friendly terms list in the adverse drug reaction report form and its association with the type of adverse drug reactions reported...
February 6, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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