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

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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
#1
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/28913820/is-ribavirin-teratogenic-in-humans-no-evidence-so-far
#2
LETTER
Vicente Soriano, Pablo Barreiro
No abstract text is available yet for this article.
September 14, 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
#3
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
https://www.readbyqxmd.com/read/28861870/dopamine-agonists-and-impulse-control-disorders-a-complex-association
#4
REVIEW
Marie Grall-Bronnec, Caroline Victorri-Vigneau, Yann Donnio, Juliette Leboucher, Morgane Rousselet, Elsa Thiabaud, Nicolas Zreika, Pascal Derkinderen, Gaëlle Challet-Bouju
Impulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The search terms were medical subject headings (MeSH) terms including "dopamine agonists" AND "disruptive disorders", "impulse control disorders", or "conduct disorders". Articles had to fulfill the following criteria to be included: (i) the target problem was an ICD; (ii) the medication was a dopaminergic drug; and (iii) the article was an original article...
August 31, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28856621/safety-concerns-with-hpv-vaccines-continue-to-linger-are-current-vaccine-pharmacovigilance-practices-sufficient
#5
LETTER
Rebecca E Chandler
No abstract text is available yet for this article.
August 30, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28853038/drug-induced-qt-prolongation-and-torsades-de-pointes-an-all-exclusive-relationship-or-time-for-an-amicable-separation
#6
Luc M Hondeghem
QT prolongation was perceived as a major antiarrhythmic mechanism, but soon became a surrogate for torsades de pointes (TdP) instead. Drugs that prolong the QT interval range from having potent torsadogenic activity to no proarrhythmic action and even antiarrhythmic effects. Blockade of hERG channels is the primary cause of TdP, but blockade/activation of other channels can also be torsadogenic. TdP is primarily caused by disturbances of TRIaD, but disturbance of wavelength can also contribute to TdP (where TRIaD is triangulation, reverse use dependence, instability and dispersion, and wavelength equals conduction velocity times effective refractory period)...
August 29, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28840504/from-big-data-to-smart-data-for-pharmacovigilance-the-role-of-healthcare-databases-and-other-emerging-sources
#7
Gianluca Trifirò, Janet Sultana, Andrew Bate
In the last decade 'big data' has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on...
August 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28840499/enrollment-and-retention-in-34-united-states-pregnancy-registries-contrasted-with-the-manufacturer-s-capture-of-spontaneous-reports-for-exposed-pregnancies
#8
Steven T Bird, Kate Gelperin, Lockwood Taylor, Leyla Sahin, Hoda Hammad, Susan E Andrade, Mohamed A Mohamoud, Sengwee Toh, Christian Hampp
INTRODUCTION: Pregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy. OBJECTIVES: The aim of this study was to evaluate postmarket capture of exposed pregnancies. METHODS: Pregnancy registries for drugs and biologics were identified in a systematic review. Through a standardized questionnaire, manufacturers provided information on (1) pregnancy registry enrollment and retention, and (2) worldwide receipt of spontaneous reports for exposed pregnancies...
August 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28815462/a-new-erice-report-considering-the-safety-of-medicines-in-the-21st-century
#9
Ivor Ralph Edwards
Pharmacovogilance policy, methods and practice require transformation at all levels to create an integrated, comprehensive, continuously improving system, fulfilling the broader remit of overall healthcare vigilance. In pursuit of this vision, energetic measures, including active engagement with patients, are needed to reduce our ignorance about many aspects of patients' experience of medical therapies and their outcomes, including the benefits, but especially the extensive harm known to be caused by medical interventions...
August 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28815480/evaluation-of-electronic-healthcare-databases-for-post-marketing-drug-safety-surveillance-and-pharmacoepidemiology-in-china
#10
Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang, Siyan Zhan
INTRODUCTION: Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS: Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance...
August 16, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28808959/deaths-from-medicines-a-systematic-analysis-of-coroners-reports-to-prevent-future-deaths
#11
Robin E Ferner, Craig Easton, Anthony R Cox
INTRODUCTION: Since legislation in 2009, coroners in England and Wales must make reports in cases where they believe it is possible to prevent future deaths. We categorised the reports and examined whether they could reveal preventable medication errors or novel adverse drug reactions. METHODS: We examined 500 coroners' reports by pre-defined criteria to identify those in which medicines played a part, and to collect information on coroners' concerns. RESULTS: We identified 99 reports (100 deaths) in which medicines or a part of the medication process or both were mentioned...
August 14, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28795368/the-9th-biennial-conference-on-signal-detection-and-interpretation-in-pharmacovigilance
#12
Vicki Osborne, Saad A W Shakir
No abstract text is available yet for this article.
August 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28786036/pharmacovigilance-using-textual-data-the-need-to-go-deeper-and-wider-into-the-con-text
#13
LETTER
Tavpritesh Sethi, Nigam H Shah
No abstract text is available yet for this article.
August 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28786035/cardiac-harms-of-sofosbuvir-systematic-review-and-meta-analysis
#14
REVIEW
Daniel Caldeira, Filipe B Rodrigues, Marta M Duarte, Carmelo Sterrantino, Márcio Barra, Nilza Gonçalves, Fausto J Pinto, Joaquim J Ferreira, João Costa
INTRODUCTION: Sofosbuvir is a new direct-acting pyrimidine nucleotide analogue antiviral drug that has shown remarkable efficacy in the treatment of hepatitis C in clinical trials. However, observational anecdotal data have recently suggested an increased risk of serious bradycardia among patients treated with sofosbuvir and amiodarone. OBJECTIVE: We aimed to estimate and characterize the cardiac safety of sofosbuvir by performing a systematic review of randomized controlled trials (RCTs)...
August 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28780741/channeling-in-the-use-of-nonprescription-paracetamol-and-ibuprofen-in-an-electronic-medical-records-database-evidence-and-implications
#15
Rachel B Weinstein, Patrick Ryan, Jesse A Berlin, Amy Matcho, Martijn Schuemie, Joel Swerdel, Kayur Patel, Daniel Fife
INTRODUCTION: Over-the-counter analgesics such as paracetamol and ibuprofen are among the most widely used, and having a good understanding of their safety profile is important to public health. Prior observational studies estimating the risks associated with paracetamol use acknowledge the inherent limitations of these studies. One threat to the validity of observational studies is channeling bias, i.e. the notion that patients are systematically exposed to one drug or the other, based on current and past comorbidities, in a manner that affects estimated relative risk...
August 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28776179/frequency-and-nature-of-medication-errors-and-adverse-drug-events-in-mental-health-hospitals-a-systematic-review
#16
REVIEW
Ghadah H Alshehri, Richard N Keers, Darren M Ashcroft
INTRODUCTION: Little is known about the frequency and nature of medication errors (MEs) and adverse drug events (ADEs) that occur in mental health hospitals. OBJECTIVES: This systematic review aims to provide an up-to-date and critical appraisal of the epidemiology and nature of MEs and ADEs in this setting. METHOD: Ten electronic databases were searched, including MEDLINE, Embase, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Scopus, British Nursing Index, ASSIA, Web of Science, and Cochrane Database of Systematic Reviews (1999 to October 2016)...
August 3, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28770534/antidepressant-induced-acute-liver-injury-a-case-control-study-in-an-italian-inpatient-population
#17
Carmen Ferrajolo, Cristina Scavone, Monia Donati, Oscar Bortolami, Giovanna Stoppa, Domenico Motola, Alfredo Vannacci, Alessandro Mugelli, Roberto Leone, Annalisa Capuano
INTRODUCTION: Pre-marketing clinical trials show that antidepressant-induced liver injury seems to be a rare adverse event. Because of short follow-up trial duration, the incidence of liver injury due to antidepressant use could be underestimated. OBJECTIVES: We aimed to quantify the risk of acute liver injury associated with antidepressant use through a case-control analysis among an inpatient population. METHODS: A multicenter study was carried out in nine Italian hospitals from October 2010 to January 2014, within the DILI-IT (Drug-Induced Liver Injury in Italy) study project...
August 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28766109/treatment-of-medication-related-osteonecrosis-of-the-jaw-and-its-impact-on-a-patient-s-quality-of-life-a-single-center-10-year-experience-from-southern-italy
#18
Giacomo Oteri, Gianluca Trifirò, Matteo Peditto, Loredana Lo Presti, Ilaria Marcianò, Francesco Giorgianni, Janet Sultana, Antonia Marcianò
INTRODUCTION: No official guidelines are available for the management of medication-related osteonecrosis of the jaw (MR-ONJ). The additional benefit of surgery after pharmacological treatment is debated by both clinicians and patients. OBJECTIVE: The aim of this study was to evaluate the changes in patients' MR-ONJ-related quality of life (QoL) after pharmacological treatment with or without surgery in a large cohort affected by MR-ONJ. METHODS: Anonymized data on patients diagnosed with MR-ONJ were extracted from the database of the Osteonecrosis of the Jaw Treatment Center (University of Messina, Italy) in the years 2005-2015...
August 1, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28766108/a-pharmacoepidemiology-database-system-for-monitoring-risk-due-to-the-use-of-medicines-by-new-zealand-primary-care-patients
#19
Andrew M Tomlin, David M Reith, David J Woods, Hywel S Lloyd, Alesha Smith, John S Fountain, Murray W Tilyard
INTRODUCTION: The use of large record-linked healthcare databases for drug safety research and surveillance is now accepted practice. New Zealand's standardized national healthcare datasets provide the potential to automate the conduct of pharmacoepidemiological studies to provide rapid validation of medicine safety signals. OBJECTIVES: Our objectives were to describe the methodology undertaken by a semi-automated computer system developed to rapidly assess risk due to drug exposure in New Zealand's population of primary care patients and to compare results from three studies with previously published findings...
August 1, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28755095/neurological-adverse-effects-attributable-to-%C3%AE-lactam-antibiotics-a-literature-review
#20
REVIEW
Samuel Deshayes, Antoine Coquerel, Renaud Verdon
β-lactam antibiotics are commonly prescribed antibiotic drugs. To describe the clinical characteristics, risk markers and outcomes of β-lactam antibiotic-induced neurological adverse effects, we performed a general literature review to provide updated clinical data about the most used β-lactam antibiotics. For selected drugs in each class available in France (ticarcillin, piperacillin, temocillin, ceftazidime, cefepime, cefpirome, ceftaroline, ceftobiprole, ceftolozane, ertapenem and aztreonam), a systematic literature review was performed up to April 2016 via an electronic search on PubMed...
July 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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