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

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https://www.readbyqxmd.com/read/30006773/safety-profile-of-benznidazole-in-the-treatment-of-chronic-chagas-disease-experience-of-a-referral-centre-and-systematic-literature-review-with-meta-analysis
#1
REVIEW
Clara Crespillo-Andújar, Emmanuele Venanzi-Rullo, Rogelio López-Vélez, Begoña Monge-Maillo, Francesca Norman, Ana López-Polín, José A Pérez-Molina
INTRODUCTION: Benznidazole is the preferred drug for treatment of Chagas disease. However, it is toxic and of limited value in chronic infection. OBJECTIVE: We aimed to estimate the rates of and factors related to adverse reactions (ARs) to benznidazole and treatment discontinuations (TDs). METHODS: A meta-analysis was performed using an electronic search of the published literature with no language restrictions until June 2017. Prospective studies were included of chronically infected patients in which at least one treatment arm included benznidazole...
July 13, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29987757/changes-in-outpatient-use-of-antibiotics-by-adults-in-the-united-states-2006-2015
#2
Mallika L Mundkur, Jessica Franklin, Krista F Huybrechts, Michael A Fischer, Aaron S Kesselheim, Jeffrey A Linder, Joan Landon, Elisabetta Patorno
INTRODUCTION: Numerous initiatives over the past decade have targeted the problem of antibiotic overuse in the US; however, the cumulative impact of such initiatives upon recent patterns of use is not known. OBJECTIVES: The aims of this study were to (1) describe general trends in outpatient antibiotic use among adults over the period 2006-2015; and (2) identify rapid shifts in use during this time period as potential indicators for key events. METHODS: This was an observational study set in the ambulatory setting...
July 9, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29956220/comment-on-review-of-case-narratives-from-fatal-overdoses-associated-with-injectable-naltrexone-for-opioid-dependence
#3
LETTER
Bernard Silverman, Gary Bloomgren, Priya Jain, Kimberley Marcopul, Alexandra Silveira, James Fratantonio, Maria Sullivan, Sarah Akerman
No abstract text is available yet for this article.
June 28, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29956219/authors-response-to-silverman-and-colleagues-comment-on-review-of-case-narratives-from-fatal-overdoses-associated-with-injectable-naltrexone-for-opioid-dependence
#4
LETTER
Nabarun Dasgupta, Roxanne Saucier, Daniel Wolfe
No abstract text is available yet for this article.
June 28, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29956218/role-of-serotonin-transporter-in-antidepressant-induced-diabetes-mellitus-a-pharmacoepidemiological-pharmacodynamic-study-in-vigibase-%C3%A2
#5
Thi Thu Ha Nguyen, Anne Roussin, Vanessa Rousseau, Jean-Louis Montastruc, François Montastruc
BACKGROUND: The association between antidepressant exposure and type 2 diabetes mellitus is still debated. Moreover, the pharmacological mechanisms remain unknown. OBJECTIVE: The objective of this study was to investigate this putative relationship with the role of antidepressant pharmacological targets using the 'pharmacoepidemiological-pharmacodynamic' method. METHODS: First, we performed case/non-case analyses in VigiBase® (the World Health Organization international database of suspected adverse drug reactions) to examine a signal of increased type 2 diabetes reporting (expressed as the reporting odds ratio and its 95% confidence interval) for antidepressants in general; examine and rank type 2 diabetes signals between the different pharmacological classes of antidepressants and the different antidepressants (58 in total)...
June 28, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29956217/gabapentin-and-pregabalin-and-risk-of-atrial-fibrillation-in-the-elderly-a-population-based-cohort-study-in-an-electronic-prescription-database
#6
Leticia Ortiz de Landaluce, Pere Carbonell, Carmen Asensio, Núria Escoda, Pilar López, Joan-Ramon Laporte
INTRODUCTION: Gabapentin and pregabalin are widely prescribed to elderly people, but data on their pharmacokinetics, safety, and efficacy in this population are scarce. Neurological adverse effects are common. Atrial fibrillation (AF) associated with their use has been described in several case reports and case series, but the incidence is unknown. OBJECTIVE: The aim of this study was to assess the association between exposure to gabapentin or pregabalin and AF in the elderly...
June 28, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29949100/what-future-healthcare-professionals-need-to-know-about-pharmacovigilance-introduction-of-the-who-pv-core-curriculum-for-university-teaching-with-focus-on-clinical-aspects
#7
Rike van Eekeren, Leàn Rolfes, Andries S Koster, Lara Magro, Gurumurthy Parthasarathi, Hussain Al Ramimmy, Tim Schutte, Daisuke Tanaka, Eugène van Puijenbroek, Linda Härmark
Adverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at universities for medical, pharmacy, dentistry and nursing students, so a core curriculum needs to be developed to teach important aspects of PV to students. In September 2016, a stakeholders' meeting was initiated on behalf of the World Health Organization (WHO) and organized by the Netherlands Pharmacovigilance Centre Lareb...
June 13, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29876835/modified-naranjo-causality-scale-for-icsrs-monarcsi-a-decision-support-tool-for-safety-scientists
#8
Shaun Comfort, Darren Dorrell, Shawman Meireis, Jennifer Fine
INTRODUCTION: Within the field of Pharmacovigilance, the most common approaches for assessing causality between a report of a drug and a corresponding adverse event are clinical judgment, probabilistic methods and algorithms. Although multiple methods using these three approaches have been proposed, there is currently no universally accepted method for assessing drug-event causality in ICSRs and variability in drug-event causality assessments is well documented. OBJECTIVE: This study describes the development and validation of an Individual Case Safety Report (ICSR) Causality Decision Support Tool to assist Safety Professionals (SPs) performing causality assessments...
June 6, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29876834/predicting-adverse-drug-effects-from-literature-and-database-mined-assertions
#9
Mary K La, Alexander Sedykh, Denis Fourches, Eugene Muratov, Alexander Tropsha
INTRODUCTION: Given that adverse drug effects (ADEs) have led to post-market patient harm and subsequent drug withdrawal, failure of candidate agents in the drug development process, and other negative outcomes, it is essential to attempt to forecast ADEs and other relevant drug-target-effect relationships as early as possible. Current pharmacologic data sources, providing multiple complementary perspectives on the drug-target-effect paradigm, can be integrated to facilitate the inference of relationships between these entities...
June 6, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29858838/cardiac-complications-attributed-to-chloroquine-and-hydroxychloroquine-a-systematic-review-of-the-literature
#10
REVIEW
Clotilde Chatre, François Roubille, Hélène Vernhet, Christian Jorgensen, Yves-Marie Pers
INTRODUCTION: Chloroquine and hydroxychloroquine are widely used in the long-term treatment of connective tissue disease and usually considered safe. However, chloroquine- or hydroxychloroquine-related cardiac disorder is a rare but severe adverse event, which can lead to death. This systematic review investigates cardiac complications attributed to chloroquine and hydroxychloroquine. METHODS: PubMED, EMBASE, and Cochrane database searches were conducted using keywords derived from MeSH terms...
June 1, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29797240/coronary-events-after-dispensing-of-ibuprofen-a-propensity-score-matched-cohort-study-versus-paracetamol-in-the-french-nationwide-claims-database-sample
#11
Mai Duong, Abdelilah Abouelfath, Regis Lassalle, Cécile Droz, Patrick Blin, Nicholas Moore
INTRODUCTION: Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide. OBJECTIVE: Our objective was to measure the risks of acute coronary syndrome (ACS) after dispensing of ibuprofen, versus paracetamol. METHODS: Propensity score 1:2-matched cohorts of ibuprofen or paracetamol treatment episodes (TEs) in Echantillon Généraliste de Bénéficiaires (EGB), the 1/97 sample of Système National des Données de Santé (SNDS), the French nationwide claims database, from 2009 to 2014, were compared...
May 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29797239/association-of-statin-use-with-increased-risk-of-musculoskeletal-conditions-a-retrospective-cohort-study
#12
Una E Makris, Carlos A Alvarez, Eric M Mortensen, Ishak A Mansi
INTRODUCTION: Musculoskeletal conditions, including osteoarthritis (OA), result in tremendous disability and cost. Statins are among the most commonly prescribed medications and their use for primary prevention in many otherwise healthy individuals, including those who are physically active, is increasing. There is conflicting evidence regarding the relationship of statin use and musculoskeletal conditions. Given the rising disability associated with musculoskeletal conditions, understanding predisposing factors, including medication-related exposures, deserves further attention...
May 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29796833/correction-to-review-of-case-narratives-from-fatal-overdoses-associated-with-injectable-naltrexone-for-opioid-dependence
#13
Roxanne Saucier, Daniel Wolfe, Nabarun Dasgupta
Introduction 3rd Paragraph.
May 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29796832/safety-of-biologics-including-biosimilars-perspectives-on-current-status-and-future-direction
#14
Ylenia Ingrasciotta, Paola M Cutroneo, Ilaria Marcianò, Thijs Giezen, Fabiola Atzeni, Gianluca Trifirò
In recent years, marketing of highly innovative and costly biologics improved the management of high-burden diseases such as autoimmune diseases, cancers, and chronic renal failure. Several widely prescribed biologics have recently lost or will shortly lose their patents, thus opening avenues to the marketing of a growing number of biosimilars worldwide, which are products similar in terms of quality, safety, and efficacy to already licensed reference products, thus allowing for potential savings in pharmaceutical expenditure...
May 23, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29796831/prescription-opioid-fatalities-examining-why-the-healer-could-be-the-culprit
#15
REVIEW
Adeleke D Adewumi, Christine E Staatz, Samantha A Hollingworth, Jason P Connor, Rosa Alati
Prescription opioid use has increased rapidly in developed countries, as have fatalities and other related adverse events. This review examines the intrinsic characteristics of opioids, including their mechanisms of action and pharmacokinetic and pharmacodynamic properties, to determine how the use of a regonised pharmacological remedy for a medically confirmed ailment could result in an accidental fatality. Opioids trigger biological processes that inhibit their own therapeutic effect. Prolonged use of opioids can result in activation of pronociceptive systems, leading to opioid-induced hyperalgesia and tolerance, while opioid metabolites can antagonise the antinociceptive action of the parent drug, also leading to opioid-induced hyperalgesia and tolerance...
May 23, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29785475/cohort-study-of-psychiatric-adverse-events-following-exposure-to-levonorgestrel-containing-intrauterine-devices-in-uk-general-practice
#16
Jim Slattery, Daniel Morales, Luis Pinheiro, Xavier Kurz
INTRODUCTION: Intrauterine devices are implantable contraceptives of which some brands steadily release levonorgestrel over an extended time period. Exposure to a levonorgestrel-releasing intrauterine device has been associated with depression and, more recently, a connection to anxiety, panic attacks, sleep problems and restlessness has been suggested. This study uses data from the THIN database of UK general practice to investigate these suggestions. METHODS: A cohort study was performed to compare the incidence of psychiatric adverse events between groups of women who were new users of levonorgestrel-releasing and non-hormonal intrauterine devices...
May 21, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29761281/characteristics-quality-and-contribution-to-signal-detection-of-spontaneous-reports-of-adverse-drug-reactions-via-the-web-radr-mobile-application-a-descriptive-cross-sectional-study
#17
Ingrid Oosterhuis, Henric Taavola, Philip M Tregunno, Petar Mas, Sara Gama, Victoria Newbould, Ola Caster, Linda Härmark
INTRODUCTION: Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. OBJECTIVE: The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app...
May 14, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29737504/inadequate-harms-reporting-in-randomized-control-trials-of-antibiotics-for-pediatric-acute-otitis-media-a-systematic-review
#18
REVIEW
Stephanie W Hum, Su Golder, Nader Shaikh
INTRODUCTION: Reporting of harms in randomized control trials is often inconsistent and inadequate. OBJECTIVE: To assess the quality of harms reporting in randomized control trials evaluating the efficacy of antibiotics used to treat pediatric acute otitis media and to investigate whether connections to pharmaceutical companies or the publication of the CONSORT-Harms extension influenced the quality of harms reporting. STUDY DESIGN AND SETTING: We considered randomized control trials that evaluated the efficacy and safety of antibiotic treatment for uncomplicated acute otitis media in children aged 0-19...
May 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29737503/a-programme-for-risk-assessment-and-minimisation-of-progressive-multifocal-leukoencephalopathy-developed-for-vedolizumab-clinical-trials
#19
Asit Parikh, Kristin Stephens, Eugene Major, Irving Fox, Catherine Milch, Serap Sankoh, Michael H Lev, James M Provenzale, Jesse Shick, Mark Patti, Megan McAuliffe, Joseph R Berger, David B Clifford
INTRODUCTION: Over the past decade, the potential for drug-associated progressive multifocal leukoencephalopathy (PML) has become an increasingly important consideration in certain drug development programmes, particularly those of immunomodulatory biologics. Whether the risk of PML with an investigational agent is proven (e.g. extrapolated from relevant experience, such as a class effect) or merely theoretical, the serious consequences of acquiring PML require careful risk minimisation and assessment...
May 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29737502/vitamin-b-6-in-health-supplements-and-neuropathy-case-series-assessment-of-spontaneously-reported-cases
#20
Florence van Hunsel, Sonja van de Koppel, Eugène van Puijenbroek, Agnes Kant
INTRODUCTION: In the literature, vitamin B6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B6 for a long time. Evidence as to whether a lower dosage range of vitamin B6 (< 50 mg/day) can also induce neuropathy is scarce. OBJECTIVE: We aim to comprehensively describe the cases of neuropathy associated with vitamin B6 received by the Netherlands Pharmacovigilance Centre Lareb and to assess the case series concerning the use of vitamin B6 and neuropathic complaints...
May 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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