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

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https://www.readbyqxmd.com/read/29143285/comment-on-adverse-drug-reaction-related-hospitalizations-in-elderly-australians-a-prospective-cross-sectional-study-in-two-tasmanian-hospitals
#1
LETTER
Mona Kargar, Alireza Ahmadvand, Kheirollah Gholami
No abstract text is available yet for this article.
November 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29134610/authors-reply-to-mona-kargar-and-colleagues-comment-on-adverse-drug-reaction-related-hospitalizations-in-elderly-australians-a-prospective-cross-sectional-study-in-two-tasmanian-hospitals
#2
LETTER
Nibu Parameswaran Nair, Leanne Chalmers, Bonnie J Bereznicki, Colin Curtain, Gregory M Peterson, Michael Connolly, Luke R Bereznicki
No abstract text is available yet for this article.
November 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29124666/study-design-and-evaluation-of-risk-minimization-measures-a-review-of-studies-submitted-to-the-european-medicines-agency-for-cardiovascular-endocrinology-and-metabolic-drugs
#3
Giampiero Mazzaglia, Sabine M J Straus, Peter Arlett, Daniela da Silva, Heidi Janssen, June Raine, Enrica Alteri
INTRODUCTION: Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products and safety-related issues. Their objectives, design, and the associated regulatory outcomes were reviewed, and conclusions were drawn that may support future progress in risk minimization evaluation...
November 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29124665/evaluation-of-definite-anaphylaxis-drug-allergy-alert-overrides-in-inpatient-and-outpatient-settings
#4
Adrian Wong, Diane L Seger, Sarah P Slight, Mary G Amato, Patrick E Beeler, Julie M Fiskio, David W Bates
INTRODUCTION: Drug-allergy interaction (DAI) alerts are generated when a known adverse sensitivity-inducing substance is prescribed. A recent study at our institution showed that providers overrode most DAI alerts, including those that warned against potentially life-threatening 'anaphylaxis'. OBJECTIVE: The aim of this study was to determine the rate of anaphylaxis overrides, the reasons for these overrides, whether the overrides were appropriate, and if harm occurred from overrides...
November 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29116609/correction-to-medication-errors-a-characterisation-of-spontaneously-reported-cases-in-eudravigilance
#5
Victoria Newbould, Steven Le Meur, Thomas Goedecke, Xavier Kurz
Correction to: Drug Saf DOI 10.1007/s40264-017-0569-3.
November 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29110252/risk-of-psoriasis-following-terbinafine-or-itraconazole-treatment-for-onychomycosis-a-population-based-case-control-comparative-study
#6
Hsien-Yi Chiu, Wei-Lun Chang, Tsen-Fang Tsai, Yi-Wen Tsai, Ming-Neng Shiu
INTRODUCTION: Several case studies have reported an association between antifungal drug use and psoriasis risk. OBJECTIVE: The objective of this study was to investigate the association between terbinafine/itraconazole exposure and psoriasis incidence. METHODS: Among patients with onychomycosis in the Taiwan National Health Insurance Research Database, 3831 incident psoriasis cases were identified during 2004-2010 and compared with 3831 age- and sex-matched controls with the same look-back period...
November 6, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29098610/reported-adverse-events-with-painkillers-data-mining-of-the-us-food-and-drug-administration-adverse-events-reporting-system
#7
Jae Min, Vicki Osborne, Allison Kowalski, Mattia Prosperi
INTRODUCTION: One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to painkillers. METHODS: We used 2015 and 2016 AE reports from the US FDA's Adverse Events Reporting System (FAERS) to conduct exploratory analysis on the demographics of those who reported painkiller-related AEs, examine the AEs most commonly associated with different types of painkillers, and identify potential safety signals...
November 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29080142/correction-to-safety-concerns-with-hpv-vaccines-continue-to-linger-are-current-vaccine-pharmacovigilance-practices-sufficient
#8
Rebecca E Chandler
The following disclaimer was missing from the article.
October 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29076063/neuropsychiatric-events-associated-with-leukotriene-modifying-agents-a-systematic-review
#9
REVIEW
Sharon W Y Law, Angel Y S Wong, Shweta Anand, Ian C K Wong, Esther W Chan
INTRODUCTION: Leukotriene-modifying agents (LTMAs) including montelukast, zafirlukast, and zileuton are approved by the US Food and Drug Administration (FDA) for the treatment of asthma and allergic rhinitis. Various neuropsychiatric events (NEs) have been reported; however, the evidence of the association is conflicting. This systematic review investigates the association between NEs and LTMAs by assessing the relevant published literature. METHODS: PubMed, EMBASE, MEDLINE, and Cochrane Library were searched using keywords...
October 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29052094/severe-physical-complications-among-survivors-of-stevens-johnson-syndrome-and-toxic-epidermal-necrolysis
#10
Cristina Olteanu, Neil H Shear, Hall F Chew, Rena Hashimoto, Raed Alhusayen, Sonia Whyte-Croasdaile, Yaron Finkelstein, Marjorie Burnett, Michael Ziv, Shachar Sade, Marc G Jeschke, Roni P Dodiuk-Gad
INTRODUCTION: Few studies have reported the physical complications among Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) survivors. OBJECTIVE: The aim of this study was to comprehensively characterize the physical complications among SJS/TEN survivors and to learn about patients' perspectives of surviving SJS/TEN. METHODS: SJS/TEN survivors older than 18 years of age were assessed by different methods: a medical interview; a questionnaire assessing patients' perspectives; thorough skin, oral mucous membrane, and ophthalmic examinations; and a retrospective assessment of medical records...
October 19, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29043496/erlotinib-plus-bevacizumab-phase-ll-study-in-patients-with-advanced-non-small-cell-lung-cancer-jo25567-updated-safety-results
#11
Terufumi Kato, Takashi Seto, Makoto Nishio, Koichi Goto, Noboru Yamamoto, Isamu Okamoto, Liang Tao, Wei Yu, Tarik Khaznadar, Kosei Tajima, Masahiko Shibata, Akihiro Seki, Nobuyuki Yamamoto
INTRODUCTION: The phase II JO25567 study compared the efficacy and safety of erlotinib plus bevacizumab vs. erlotinib alone as first-line therapy for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). OBJECTIVE: Our objective is to provide updated analyses of safety and the assessment of manageability of specific adverse events. METHODS: Patients with stage IIIB/IV or recurrent, non-squamous, EGFR mutation-positive NSCLC were randomized to receive erlotinib plus bevacizumab or erlotinib...
October 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29027148/safety-of-russian-backbone-trivalent-live-attenuated-seasonal-influenza-vaccine-in-healthy-subjects-open-label-non-randomized-phase-4-study
#12
Prashant V Nigwekar, Anuj Kumar, Vikram V Padbidri, Amlan Choudhury, Amol B Chaudhari, Prasad S Kulkarni
INTRODUCTION AND AIM: A trivalent live attenuated influenza vaccine (Nasovac-S(®)) was developed and licensed in India. A phase 4 study was conducted to assess safety. METHODOLOGY: This non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries. RESULTS: Among 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18-49 years old and 100 were 50 years and older...
October 12, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29019038/utilisation-and-safety-of-deferasirox-results-from-an-observational-cohort-study-in-england
#13
Vicki Osborne, Miranda Davies, Deborah Layton, Saad A W Shakir
INTRODUCTION: Deferasirox (EXJADE(®), Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. OBJECTIVE: The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. METHOD: A single exposure observational cohort study design was used...
October 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28980202/an-update-on-isop-special-interest-groups-sigs
#14
EDITORIAL
Deirdre McCarthy, Priya Bahri, Joanne Barnes, Jean-Christophe Delumeau, Brian Edwards, Mira Harrison-Woolrych
No abstract text is available yet for this article.
October 4, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28975584/overview-of-pharmacovigilance-system-in-vietnam-lessons-learned-in-a-resource-restricted-country
#15
Khac-Dung Nguyen, Phuong-Thuy Nguyen, Hoang-Anh Nguyen, Anne Roussin, Jean-Louis Montastruc, Haleh Bagheri, Sten Olsson
Drug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of drugs in each nation is needed to identify and manage the exact drug-related problems faced by patients in these countries. Vietnam launched its university-based National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in 2009, a significant step towards catching up with international trends...
October 3, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28965265/preferences-of-patients-and-pharmacists-with-regard-to-the-management-of-drug-drug-interactions-a-choice-based-conjoint-analysis
#16
Mette Heringa, Annemieke Floor-Schreudering, Hans Wouters, Peter A G M De Smet, Marcel L Bouvy
INTRODUCTION: The management of drug-drug interactions (DDIs) is a complex process in which risk-benefit assessments should be combined with the patient's perspective. OBJECTIVE: The aim of this study was to determine patients' and pharmacists' preferences regarding DDI management. METHODS: We conducted a choice-based conjoint survey about a fictitious DDI concerning the combination of a cardiovascular drug and an antibiotic for pneumonia...
September 30, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28956286/all-cause-and-drug-related-medical-events-associated-with-overuse-of-gabapentin-and-or-opioid-medications-a-retrospective-cohort-analysis-of-a-commercially-insured-us-population
#17
Alyssa M Peckham, Kathleen A Fairman, David A Sclar
INTRODUCTION: Overuse of gabapentin and/or opioids occurs in a small percentage of patients at > 3-fold labeled dosages. Gabapentin may potentiate opioid effects. OBJECTIVE: The aim was to assess patient harm, defined as use of inpatient hospital (IPH) or emergency department (ED) services, associated with overuse of gabapentin with or without concomitant overuse of opioids. DATA SOURCE: Data were sourced from the Truven Health MarketScan(®) Commercial Claims and Encounters database, for the years 2013-2015...
September 27, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28952138/can-sglt2-inhibitors-cause-acute-renal-failure-plausible-role-for-altered-glomerular-hemodynamics-and-medullary-hypoxia
#18
REVIEW
Auryan Szalat, Amichai Perlman, Mordechai Muszkat, Mogher Khamaisi, Zaid Abassi, Samuel N Heyman
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) provide outstanding long-term cardiovascular and renal protection in high-risk patients with type 2 diabetes mellitus. Yet, despite encouraging renal safety outcomes reported in the EMPA-REG study, scattered reports suggest that there might be a risk for acute kidney injury (AKI), which may occasionally be fatal or might require renal replacement therapy. Reduced trans-glomerular pressure with a modest decline in kidney function, an inherent characteristic of SGLT2i therapy, conceivably forms the basis for the long-term renal protection, resembling agents that block the renin-angiotensin-aldosterone (RAAS) axis...
September 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28933055/safety-concerns-reported-by-patients-identified-in-a-collaborative-signal-detection-workshop-using-vigibase-results-and-reflections-from-lareb-and-uppsala-monitoring-centre
#19
Sarah Watson, Rebecca E Chandler, Henric Taavola, Linda Härmark, Birgitta Grundmark, Alem Zekarias, Kristina Star, Florence van Hunsel
INTRODUCTION: Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries. OBJECTIVE: Our objective was to explore the contribution of patient reports to global signal detection in VigiBase. METHODS: Data were retrieved from VigiBase in September 2016...
September 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28905299/use-of-antihypertensive-drugs-and-risk-of-malignant-melanoma-a-meta-analysis-of-observational-studies
#20
REVIEW
Huilin Tang, Shuangshuang Fu, Suodi Zhai, Yiqing Song, Jiali Han
INTRODUCTION: Several antihypertensive drugs are photosensitizing and may promote the development of malignant melanoma (MM), but evidence remains inconsistent. We sought to quantify the association between use of antihypertensive drugs and MM risk. METHODS: We systematically searched PubMed, Embase, and CENTRAL from inception to August 17, 2017 to identify observational studies that reported the MM risk associated with the use of antihypertensive drugs. A random-effects meta-analysis was used to estimate the odds ratio (OR) with 95% confidence interval (CI)...
September 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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