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

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https://www.readbyqxmd.com/read/29785475/cohort-study-of-psychiatric-adverse-events-following-exposure-to-levonorgestrel-containing-intrauterine-devices-in-uk-general-practice
#1
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
#2
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
#3
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
#4
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
#5
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
https://www.readbyqxmd.com/read/29737501/safety-of-tamsulosin-a-systematic-review-of-randomized-trials-with-a-focus-on-women-and-children
#6
REVIEW
Steven A Kaplan, Bilal I Chughtai
INTRODUCTION: Although tamsulosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), it has also been assessed in clinical studies for other conditions/symptoms and in other populations such as women and children. In this systematic review of randomized studies, the overall safety of tamsulosin was assessed, focusing on these understudied populations. METHODS: Literature searches were conducted using Embase, Medline, and PubMed (inception-December 2015)...
May 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29737500/correction-to-drug-induced-dental-caries-a-disproportionality-analysis-using-data-from-vigibase
#7
Emilie Patras de Campaigno, Inès Kebir, Jean-Louis Montastruc, Manuela Rueter, Delphine Maret, Maryse Lapeyre-Mestre, Brigitte Sallerin, Fabien Despas
Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated.
May 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29725942/exploring-the-potential-routine-use-of-electronic-healthcare-record-data-to-strengthen-early-signal-assessment-in-uk-medicines-regulation-proof-of-concept-study
#8
Katherine Donegan, Rebecca Owen, Helena Bird, Brian Burch, Alex Smith, Phil Tregunno
INTRODUCTION: Electronic healthcare record (EHR) databases are used within pharmacoepidemiology studies to confirm or refute safety signals arising from spontaneous adverse event reports. However, there has been limited routine use of such data earlier in the signal management process, to help rapidly contextualise signals and strengthen preliminary assessment or to inform decisions regarding action including the need for further studies. This study explores the value of EHR used in this way within a regulatory environment via an automated analysis platform...
May 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29725941/authors-reply-to-tomoyuki-kawada-s-comment-on-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
#9
LETTER
Alyssa M Peckham, Kathleen A Fairman, David A Sclar
No abstract text is available yet for this article.
May 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29725940/comment-on-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
#10
LETTER
Tomoyuki Kawada
No abstract text is available yet for this article.
May 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29721822/challenges-and-opportunities-for-the-traceability-of-biological-medicinal-products
#11
Kevin Klein, Pieter Stolk
This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited traceability of biologics, in particular with regard to the batch number, is associated with incomplete recording of exposure information in clinical practice. The current pharmaceutical barcode standards in the EU do not support the automatic recording of dynamic product information, such as batch numbers and expiry dates, by means of electronic barcode scanning in clinical practice...
May 2, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29721821/active-safety-surveillance-in-africa-pragmatism-and-agility
#12
LETTER
Alexander N O Dodoo
No abstract text is available yet for this article.
May 2, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29714005/potentially-inappropriate-medication-prescribing-and-risk-of-unplanned-hospitalization-among-the-elderly-a-self-matched-case-crossover-study
#13
Izumi Sato, Yosuke Yamamoto, Genta Kato, Koji Kawakami
INTRODUCTION/OBJECTIVES: An association between potentially inappropriate medication (PIM) use and adverse events has been established. However, PIM criteria for elderly patients and medical circumstance vary in different countries. We investigated the association between PIM use according to Japanese guidelines and unplanned hospitalization among elderly patients. DESIGN: A case-crossover study was conducted. SETTING/PARTICIPANTS: We used the Japanese Medical Data Vision database of 17...
April 30, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29714004/non-bleeding-adverse-events-with-the-use-of-direct-oral-anticoagulants-a-sequence-symmetry-analysis
#14
Géric Maura, Cécile Billionnet, Joël Coste, Alain Weill, Anke Neumann, Antoine Pariente
INTRODUCTION: Postmarketing pharmacovigilance reports have raised concerns about non-bleeding adverse events associated with direct oral anticoagulants (DOACs), but only limited results are available from large claims databases. OBJECTIVE: The aim of this study was to assess the potential association between DOAC initiation and the onset of four types of non-bleeding adverse events by sequence symmetry analysis (SSA). METHODS: SSA was performed using nationwide data from the French National Healthcare databases (Régime Général, 50 million beneficiaries) to assess a cohort of 386,081 DOAC new users for the first occurrence of four types of non-bleeding outcomes: renal, hepatic, skin outcomes identified by using hospitalization discharge diagnoses, and gastrointestinal outcomes by using medication reimbursement...
April 30, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29714003/healthcare-databases-for-drug-safety-research-data-validity-assessment-remains-crucial
#15
Nigel S B Rawson, Carl D'Arcy
Administrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data...
April 30, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29696507/safety-experience-during-real-world-use-of-injectable-artesunate-in-public-health-facilities-in-ghana-and-uganda-outcomes-of-a-modified-cohort-event-monitoring-study-cemisa
#16
H Hilda Ampadu, Alexander N O Dodoo, Samuel Bosomprah, Samantha Akakpo, Pierre Hugo, Helga Gardarsdottir, H G M Leufkens, Dan Kajungu, Kwaku Poku Asante
INTRODUCTION: Injectable artesunate (Inj AS) is the World Health Organization (WHO)-recommended product for treating severe malaria. However, despite widespread usage, there are few published safety studies involving large populations in real-world settings. In this study, we sought to assess the incidence of common adverse events (AEs) following the intake of Inj AS in real-life settings. METHODS: This is a modified cohort event monitoring study involving patients who were administered with Inj AS at eight sites (four each in Ghana and Uganda) between May and December 2016...
April 25, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29671224/effectiveness-evaluation-of-additional-risk-minimization-measures-for-adolescent-use-of-aripiprazole-in-the-european-union-results-from-a-post-authorization-safety-study
#17
Wally Landsberg, Imad Al-Dakkak, Antonia Coppin-Renz, Uli Geis, Timothy Peters-Strickland, Emiel van Heumen, Mirza Rahman
INTRODUCTION: Two risk minimization (RM) tools-a healthcare professional frequently asked questions (HCP-FAQs) brochure and a patient/caregiver information brochure (PCIB)-were developed for HCPs and for adolescents (aged ≥ 13 years) receiving aripiprazole for bipolar I mania and their caregivers. OBJECTIVES: This study evaluated the effectiveness of these RM tools in improving the awareness and education of HCPs and patients/caregivers. METHOD: The RM tools were distributed to HCPs (identified in agreement with the marketing authorization holder [MAH] and local regulatory authorities), who in turn distributed the PCIBs to patients/caregivers...
April 18, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29644579/comparison-of-data-on-serious-adverse-events-and-mortality-in-clinicaltrials-gov-corresponding-journal-articles-and-fda-medical-reviews-cross-sectional-analysis
#18
Richeek Pradhan, Sonal Singh
INTRODUCTION: Inconsistencies in data on serious adverse events (SAEs) and mortality in ClinicalTrials.gov and corresponding journal articles pose a challenge to research transparency. OBJECTIVE: The objective of this study was to compare data on SAEs and mortality from clinical trials reported in ClinicalTrials.gov and corresponding journal articles with US Food and Drug Administration (FDA) medical reviews. METHODS: We conducted a cross-sectional study of a randomly selected sample of new molecular entities approved during the study period 1 January 2013 to 31 December 2015...
April 11, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29627926/the-burden-of-adverse-drug-reactions-due-to-artemisinin-based-antimalarial-treatment-in-selected-ugandan-health-facilities-an-active-follow-up-study
#19
Helen Byomire Ndagije, Victoria Nambasa, Leonard Manirakiza, Donna Kusemererwa, Dan Kajungu, Sten Olsson, Niko Speybroeck
INTRODUCTION: Uganda has rapidly increased access to antimalarial medicines in an effort to address the huge malaria disease burden. Pharmacovigilance information is important to guide policy decisions. OBJECTIVES: The purpose of this study was to establish the burden of adverse drug reactions (ADRs) and associated risk factors for developing ADRs to artemisinin-based antimalarial treatment in Uganda. METHODS: An active follow-up study was conducted between April and July 2017 in a cohort of patients receiving treatment for uncomplicated malaria in the Iganga, Mayuge, and Kampala districts...
April 7, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29623648/osteoporosis-related-fractures-in-hiv-infected-patients-receiving-long-term-tenofovir-disoproxil-fumarate-an-observational-cohort-study
#20
Ayami Komatsu, Atsushi Ikeda, Akio Kikuchi, Chiaki Minami, Motomu Tan, Shuzo Matsushita
INTRODUCTION: Patients with HIV infection may have a higher prevalence of osteoporosis and osteopenia, as well as an increased risk of bone fracture compared with non-HIV-infected individuals. Antiretroviral therapy is thought to be one of factors associated to osteoporosis-related bone fractures. OBJECTIVE: The aim of this study was to assess the effects of long-term exposure to tenofovir disoproxil fumarate (TDF) on the cumulative risk of osteoporosis-related bone fractures in Japanese patients with HIV infection...
April 5, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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