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

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https://www.readbyqxmd.com/read/28634824/association-of-parkinsonism-or-parkinson-disease-with-polypharmacy-in-the-year-preceding-diagnosis-a-nested-case-control-study-in-south-korea
#1
Hae-Young Park, Ji-Won Park, Hyun Soon Sohn, Jin-Won Kwon
INTRODUCTION: Published studies on the association between polypharmacy and parkinsonism or Parkinson disease are very limited. OBJECTIVE: The objective of this study was to investigate whether polypharmacy is associated with parkinsonism or Parkinson disease in elderly patients. METHODS: From a South Korean national health insurance sample cohort database for 2002-2013, we matched parkinsonism cases (defined by diagnosis codes for parkinsonism/Parkinson disease) and Parkinson disease cases (patients who had records for both Parkinson disease diagnosis and anti-Parkinson disease drug prescriptions) with controls...
June 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28623527/updating-the-evidence-of-the-interaction-between-clopidogrel-and-cyp2c19-inhibiting-selective-serotonin-reuptake-inhibitors-a-cohort-study-and-meta-analysis
#2
Katsiaryna Bykov, Sebastian Schneeweiss, Robert J Glynn, Murray A Mittleman, David W Bates, Joshua J Gagne
INTRODUCTION: We previously found that patients who initiate clopidogrel while treated with a cytochrome P450 (CYP) 2C19-inhibiting selective serotonin reuptake inhibitor (SSRI) have a higher risk of subsequent ischemic events than patients treated with other SSRIs. It is not known whether initiating an inhibiting SSRI while treated with clopidogrel will also increase risk of ischemic events. OBJECTIVE: The aim of this study was to assess clinical outcomes following initiation of a CYP2C19-inhibiting SSRI versus initiation of other SSRIs among patients treated with clopidogrel and to update existing evidence on the clinical impact of clopidogrel-SSRI interaction...
June 16, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28620871/lipophilic-statins-and-the-risk-of-intracranial-hemorrhage-following-ischemic-stroke-a-population-based-study
#3
Kieran L Quinn, Erin M Macdonald, Muhammad M Mamdani, Christina Diong, David N Juurlink
BACKGROUND: Statins are commonly prescribed for the secondary prevention of ischemic stroke, but there is conflicting evidence as to whether they increase the risk of intracranial hemorrhage. Lipophilic statins cross the blood-brain barrier more freely than hydrophilic statins and may therefore increase the risk of intracranial hemorrhage. OBJECTIVE: To determine whether, in older patients following ischemic stroke, receipt of lipophilic statins was associated with differences in the risk of intracranial hemorrhage...
June 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28597251/occurrence-of-multiple-sclerosis-after-drug-exposure-insights-from-evidence-mapping
#4
Ippazio Cosimo Antonazzo, Emanuel Raschi, Luca Vignatelli, Elisa Baldin, Trond Riise, Roberto D'Alessandro, Fabrizio De Ponti, Elisabetta Poluzzi
INTRODUCTION: The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated. OBJECTIVE: The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association. METHODS: A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS...
June 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28593504/an-algorithm-to-identify-generic-drugs-in-the-fda-adverse-event-reporting-system
#5
Geetha Iyer, Sathiya Priya Marimuthu, Jodi B Segal, Sonal Singh
INTRODUCTION: Although generic drugs constitute approximately 88% of drugs prescribed in the US, there are no reliable methods to identify generic drugs in the US FDA Adverse Event Reporting System (FAERS). OBJECTIVE: The aim of this study was to develop an algorithm for identifying generic drugs in the FAERS. DATA SOURCE: We used 1237 adverse event reports for tamsulosin, levothyroxine, and amphetamine/dextroamphetamine from the publicly available FAERS from 2011-2013, and 277 source case narratives obtained from the FDA...
June 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28585153/second-generation-antipsychotics-and-metabolic-side-effects-a-systematic-review-of-population-based-studies
#6
REVIEW
Lauren Hirsch, Jaeun Yang, Lauren Bresee, Nathalie Jette, Scott Patten, Tamara Pringsheim
INTRODUCTION: There is strong evidence from randomized controlled trials (RCTs) that second-generation antipsychotic (SGA) medications are associated with metabolic adverse events. However, with the recent increases in the use of SGAs worldwide and frequent off-label use, it is unclear whether these associations are generalizable to populations beyond those included in RCTs. OBJECTIVES: This review aims to characterize the impact of SGAs on the population through a systematic review of population-based studies of SGA users...
June 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28585152/overview-of-the-safety-of-anti-vegf-drugs-analysis-of-the-italian-spontaneous-reporting-system
#7
Paola Maria Cutroneo, Claudia Giardina, Valentina Ientile, Simona Potenza, Laura Sottosanti, Carmen Ferrajolo, Costantino J Trombetta, Gianluca Trifirò
INTRODUCTION: Anti-vascular endothelial growth factor (anti-VEGF) drugs are widely used for the treatment of several cancers and retinal diseases. The systemic use of anti-VEGF drugs has been associated with an increased risk of serious adverse reactions. Whether this risk is also related to intravitreal administration of anti-VEGF drugs is unclear. OBJECTIVE: The aim of this study was to provide an overview of the safety of anti-VEGF drugs in oncology and ophthalmology settings using the Italian Spontaneous Reporting System (SRS)...
June 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28578518/using-simulated-data-to-assess-case-crossover-designs-for-studying-less-transient-effects-of-drugs
#8
LETTER
Malcolm Maclure
No abstract text is available yet for this article.
June 3, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28560588/the-power-of-the-case-narrative%C3%A2-can-it-be-brought-to-bear-on-duplicate-detection
#9
LETTER
G Niklas Norén
No abstract text is available yet for this article.
May 30, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28555362/the-incidence-of-drug-and-herbal-and-dietary-supplement-induced-liver-injury-preliminary-findings-from-gastroenterologist-based-surveillance-in-the-population-of-the-state-of-delaware
#10
Maricruz Vega, Manisha Verma, David Beswick, Stephanie Bey, Jared Hossack, Nathan Merriman, Ashish Shah, Victor Navarro
BACKGROUND AND AIM: The population-based incidence rate of drug-induced liver injury (DILI) in the USA is not known. The Drug-Induced Liver Injury Network (DILIN) accrues cases of hepatotoxicity due to medications and herbal and dietary supplements (HDS) from limited geographical areas. The current analysis was an ancillary study of DILIN aimed at determining the annual incidence of DILI in the USA on a population basis, through surveillance in the state of Delaware. METHODS: At the outset of the study, there were 41 gastroenterologists in the state of Delaware and all agreed to participate in surveillance for DILI, which comprised active reporting of suspected cases to the DILIN...
May 29, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28547654/potential-teratogenic-effects-of-clomiphene-citrate
#11
REVIEW
Alessandra Scaparrotta, Francesco Chiarelli, Alberto Verrotti
Clomiphene citrate (CC) is the oldest drug used to regulate the process of ovulation. Considering the great use of CC over the last 40 years, it is important to understand the possible risks associated with its use. The aim of this review was to evaluate the possible teratogenic effects of CC, analyzing results obtained from animal and human studies. The pharmacokinetics of CC and possible mechanisms involved in teratogenesis are examined. Fetal exposure to CC is possible due to the long half-life of CC and its metabolites...
May 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28540672/communication-on-safety-of-medicines-in-europe-current-practices-and-general-practitioners-awareness-and-preferences
#12
Sieta T de Vries, Maartje J M van der Sar, Amelia Cupelli, Ilaria Baldelli, Anna Marie Coleman, Dolores Montero, Ivana Šipić, Adriana Andrić, Annika Wennberg, Jane Ahlqvist-Rastad, Petra Denig, Peter G M Mol
INTRODUCTION: National competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs). OBJECTIVE: The aim of this study was to assess current European NCA safety communication practices and to investigate European GPs' awareness of and preferences for safety communications on medicines...
May 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28534236/the-new-phase-of-isop
#13
EDITORIAL
Sten Olsson, Ian C K Wong, Jean-Christophe Delumeau, Mira Harrison-Woolrych
No abstract text is available yet for this article.
May 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28528487/role-of-medicines-of-unknown-identity-in-adverse-drug-reaction-related-hospitalizations-in-developing-countries-evidence-from-a-cross-sectional-study-in-a-teaching-hospital-in-the-lao-people-s-democratic-republic
#14
Céline Caillet, Chanvilay Sichanh, Gaëtan Assemat, Myriam Malet-Martino, Agnès Sommet, Haleh Bagheri, Noudy Sengxeu, Niphonh Mongkhonmath, Mayfong Mayxay, Lamphone Syhakhang, Maryse Lapeyre-Mestre, Paul N Newton, Anne Roussin
INTRODUCTION: The health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People's Democratic Republic (PDR). METHODS: All unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h...
May 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28508325/preliminary-results-of-a-novel-algorithmic-method-aiming-to-support-initial-causality-assessment-of-routine-pharmacovigilance-case-reports-for-medication-induced-liver-injury-the-pv-rucam
#15
Erik Scalfaro, Henk Johan Streefkerk, Michael Merz, Christoph Meier, David Lewis
INTRODUCTION: Data incompleteness in pharmacovigilance (PV) health records limits the use of current causality assessment methods for drug-induced liver injury (DILI). In addition to the inherent complexity of this adverse event, identifying cases of high causal probability is difficult. OBJECTIVE: The aim was to evaluate the performance of an improved, algorithmic and standardised method called the Pharmacovigilance-Roussel Uclaf Causality Assessment Method (PV-RUCAM), to support assessment of suspected DILI...
May 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28497250/people-s-understanding-of-verbal-risk-descriptors-in-patient-information-leaflets-a-cross-sectional-national-survey-of-18-to-65-year-olds-in-england
#16
Rebecca K Webster, John Weinman, G James Rubin
INTRODUCTION: Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. OBJECTIVES: The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and alternative verbal risk descriptors, in the context of mild and severe side effects. METHODS: A cross-sectional online survey was carried out by a market research company recruiting participants aged between 18 and 65 years living in England...
May 11, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28474287/evaluation-of-the-case-crossover-cco-study-design-for-adverse-drug-event-detection
#17
Zachary Burningham, Tao He, Chia-Chen Teng, Xi Zhou, Jonathan Nebeker, Brian C Sauer
INTRODUCTION: The case-crossover (CCO) design was originally intended to study exposures characterized as intermittent with acute effects. The performance of the CCO design is not well characterized under alternative exposure and outcome relationships. OBJECTIVE: The purpose of this study was to evaluate the ability of the CCO to identify simulated treatment effects under different drug exposures and outcomes relationships while varying the duration of the 1:1 matched risk and control windows...
May 4, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28455793/detecting-signals-of-disproportionate-reporting-from-singapore-s-spontaneous-adverse-event-reporting-system-an-application-of-the-sequential-probability-ratio-test
#18
Cheng Leng Chan, Sowmya Rudrappa, Pei San Ang, Shu Chuen Li, Stephen J W Evans
INTRODUCTION: The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health. OBJECTIVE: This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context. METHODS: We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4...
April 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28439716/antipsychotic-prescribing-to-patients-diagnosed-with-dementia-without-a-diagnosis-of-psychosis-in-the-context-of-national-guidance-and-drug-safety-warnings-longitudinal-study-in-uk-general-practice
#19
S Jill Stocks, Evangelos Kontopantelis, Roger T Webb, Anthony J Avery, Alistair Burns, Darren M Ashcroft
INTRODUCTION: Policy interventions to address inappropriate prescribing of antipsychotic drugs to older people diagnosed with dementia are commonplace. In the UK, warnings were issued by the Medicines Healthcare products Regulatory Agency in 2004, 2009 and 2012 and the National Institute for Health and Care Excellence guidance was published in 2006. It is important to evaluate the impact of such interventions. METHODS: We analysed routinely collected primary-care data from 111,346 patients attending one of 689 general practices contributing to the Clinical Practice Research Datalink to describe the temporal changes in the prescribing of antipsychotic drugs to patients aged 65 years or over diagnosed with dementia without a concomitant psychosis diagnosis from 2001 to 2014 using an interrupted time series and a before-and-after design...
April 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28425072/comment-on-evaluation-of-facebook-and-twitter-monitoring-to-detect-safety-signals-for-medical-products-an-analysis-of-recent-fda-safety-alerts
#20
LETTER
Viroj Wiwanitkit
No abstract text is available yet for this article.
April 19, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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