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Drug Safety: An International Journal of Medical Toxicology and Drug Experience | Page 2

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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
#21
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
#22
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
#23
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
#24
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
#25
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
#26
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
#27
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
#28
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
#29
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
#30
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/30830572/established-and-emerging-immunological-complications-of-biological-therapeutics-in-multiple-sclerosis
#31
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/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
#32
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...
June 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
#33
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...
May 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30471046/diagnostic-algorithms-for-cardiovascular-death-in-administrative-claims-databases-a-systematic-review
#34
REVIEW
Sonal Singh, Hassan Fouayzi, Kathryn Anzuoni, Leah Goldman, Jea Young Min, Marie Griffin, Carlos G Grijalva, James A Morrow, Christine C Whitmore, Charles E Leonard, Mano Selvan, Vinit Nair, Yunping Zhou, Sengwee Toh, Andrew Petrone, James Williams, Elnara Fazio-Eynullayeva, Richard Swain, D Tyler Coyle, Susan Andrade
INTRODUCTION: Valid algorithms for identification of cardiovascular (CV) deaths allow researchers to reliably assess the CV safety of medications, which is of importance to regulatory science, patient safety, and public health. OBJECTIVE: The aim was to conduct a systematic review of algorithms to identify CV death in administrative health plan claims databases. METHODS: We searched MEDLINE, EMBASE, and Cochrane Library for English-language studies published between January 1, 2012 and October 17, 2017...
April 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30535629/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
#35
Birgit Ehlken, Lennart Nathell, Annegret Gohlke, Derya Bocuk, Massoud Toussi, Stefan Wohlfeil
INTRODUCTION: Hypersensitivity reactions (HSRs) are among the known adverse events of intravenous (i.v.) iron products. Of these, particularly severe HSRs such as anaphylaxis are of great clinical concern due to their life-threatening potential. METHODS: This was a retrospective pharmacoepidemiological study with a case-population design evaluating the number of reported severe HSRs following administration of the two i.v. iron products-ferric carboxymaltose and iron (III) isomaltoside 1000-in relation to exposure in European countries from January 2014 to December 2017...
March 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30421345/correcting-qt-for-heart-rate-when-both-are-affected-by-a-drug
#36
Georg Ferber
No abstract text is available yet for this article.
March 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30343418/drug-induced-liver-injury-highlights-of-the-recent-literature
#37
REVIEW
Mark Real, Michele S Barnhill, Cory Higley, Jessica Rosenberg, James H Lewis
Drug-induced liver injury (DILI), herbal-induced liver injury, and herbal and dietary supplement (HDS)-induced liver injury are an important aspect of drug safety. Knowledge regarding responsible drugs, mechanisms, risk factors, and the diagnostic tools to detect liver injury have continued to grow in the past year. This review highlights what we considered the most significant publications from among more than 1800 articles relating to liver injury from medications, herbal products, and dietary supplements in 2017 and 2018...
March 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30255349/implications-of-individual-qt-rr-profiles-part-1-inaccuracies-and-problems-of-population-specific-qt-heart-rate-corrections
#38
Marek Malik, Christine Garnett, Katerina Hnatkova, Jose Vicente, Lars Johannesen, Norman Stockbridge
INTRODUCTION: Universal QT correction formulas are potentially problematic in corrected QT (QTc) interval comparisons at different heart rates. Instead of individual-specific corrections, population-specific corrections are occasionally used based on QT/RR data pooled from all study subjects. OBJECTIVE: To investigate the performance of individual-specific and population-specific corrections, a statistical modeling study was performed using QT/RR data of 523 healthy subjects...
March 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
#39
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/30739254/ustekinumab-safety-in-psoriasis-psoriatic-arthritis-and-crohn-s-disease-an-integrated-analysis-of-phase-ii-iii-clinical-development-programs
#40
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
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