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

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https://www.readbyqxmd.com/read/28735357/promoting-and-protecting-public-health-how-the-european-union-pharmacovigilance-system-works
#1
Aniello Santoro, Georgy Genov, Almath Spooner, June Raine, Peter Arlett
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks...
July 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28733971/the-fetal-safety-of-enoxaparin-use-during-pregnancy-a-population-based-retrospective-cohort-study
#2
Meital Shlomo, Rafael Gorodischer, Sharon Daniel, Arnon Wiznitzer, Ilan Matok, Boris Fishman, Gideon Koren, Amalia Levy
INTRODUCTION: Enoxaparin is widely used during pregnancy as pregnancy is a hypercoagulable state; however, its fetal safety has scarcely been investigated. OBJECTIVE: Our study aimed to examine fetal safety following enoxaparin exposure during pregnancy. METHODS: A population-based, retrospective cohort study was performed by linking computerized databases, including the drug dispensing registries of Clalit Health Services in Israel and maternal and infant hospital records, between 1998 and 2009...
July 21, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28702803/brian-a-baldo-safety-of-biologics-therapy-monoclonal-antibodies-cytokines-fusion-proteins-hormones-enzymes-coagulation-proteins-vaccines-botulinum-toxins-1st-edition-springer-2016-print-book-isbn-978-3-319-30470-0-e-book-isbn-978-3-319-30472-4
#3
https://www.readbyqxmd.com/read/28698988/medication-errors-a-characterisation-of-spontaneously-reported-cases-in-eudravigilance
#4
Victoria Newbould, Steven Le Meur, Thomas Goedecke, Xavier Kurz
INTRODUCTION: Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors. OBJECTIVE: This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002-2015 before the release of EU good practice guidance. METHODS: Case reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA(®)) term is reported and included in the Standardised MedDRA(®) Query (SMQ) for medication errors...
July 11, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28695474/statin-therapy-and-risk-of-intracranial-hemorrhage-in-patients-with-ischemic-stroke
#5
LETTER
Matilda Florentin, Moses S Elisaf
No abstract text is available yet for this article.
July 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28689334/safety-and-interactions-of-direct-oral-anticoagulants-with-antiarrhythmic-drugs
#6
REVIEW
Ipek Celikyurt, Christoph R Meier, Michael Kühne, Beat Schaer
Direct oral anticoagulants (DOACs) are novel direct-acting medications that are selective for either thrombin or activated factor X. Due to their obvious benefits for patients (fewer interactions, broader therapeutic window, etc.), they are increasingly used as an alternative to warfarin, phenprocoumon, or acenocoumarol. One of the major indications for use of DOACs is stroke prevention in patients with atrial fibrillation (AF). However, interactions still exist, especially in combination with antiarrhythmic drugs (AADs), which are frequently given to AF patients for rhythm or rate control...
July 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28689333/the-ribavirin-pregnancy-registry-an-interim-analysis-of-potential-teratogenicity-at-the-mid-point-of-enrollment
#7
Susan M Sinclair, Judith K Jones, Richard K Miller, Michael F Greene, Paul Y Kwo, Willis C Maddrey
INTRODUCTION: Significant teratogenic effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in women who are pregnant and in the male sexual partners of women who are pregnant. Both sexes are advised to avoid pregnancy for 6 months after exposure. The Ribavirin Pregnancy Registry was established in 2003 to monitor pregnancy exposures to ribavirin for signals of possible human teratogenicity. METHODS: This voluntary registry enrolls pregnant women with prenatal exposure to ribavirin...
July 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28681266/muscular-adverse-drug-reactions-associated-with-proton-pump-inhibitors-a-disproportionality-analysis-using-the-italian-national-network-of-pharmacovigilance-database
#8
Alice Capogrosso Sansone, Irma Convertino, Maria Teresa Galiulo, Stefano Salvadori, Stefania Pieroni, Tamara Knezevic, Stefania Mantarro, Alessandra Marino, Manfred Hauben, Corrado Blandizzi, Marco Tuccori
INTRODUCTION: Proton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports. AIM: This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database. METHODS: A disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016...
July 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28676981/comment-on-patient-reporting-in-the-eu-analysis-of-eudravigilance-data
#9
LETTER
Farid Kheloufi, Anne Default, Frank Rouby, Olivier Blin, Joelle Micallef
No abstract text is available yet for this article.
July 4, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28674842/clinical-relevance-and-predictive-value-of-damage-biomarkers-of-drug-induced-kidney-injury
#10
Sandra L Kane-Gill, Pamela L Smithburger, Kianoush Kashani, John A Kellum, Erin Frazee
Nephrotoxin exposure accounts for up to one-fourth of acute kidney injury episodes in hospitalized patients, and the associated consequences are as severe as acute kidney injury due to other etiologies. As the use of nephrotoxic agents represents one of the few modifiable risk factors for acute kidney injury, clinicians must be able to identify patients at high risk for drug-induced kidney injury rapidly. Recently, significant advancements have been made in the field of biomarker utilization for the prediction and detection of acute kidney injury...
July 3, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28664356/signal-of-miscarriage-with-aripiprazole-a-disproportionality-analysis-of-the-japanese-adverse-drug-event-report-database
#11
Takamasa Sakai, Fumiko Ohtsu, Chiyo Mori, Kouichi Tanabe, Nobuyuki Goto
INTRODUCTION: With recent advances in medicines, many patients with schizophrenia have become able to conceive. One common second-generation antipsychotic given to patients with schizophrenia is aripiprazole. The label information of aripiprazole in Japan states that according to one case report "there is a report of miscarriage in clinical trial". OBJECTIVE: The aim of this study was to evaluate the relationship between aripiprazole and miscarriage by conducting a disproportionality analysis of an adverse drug event report database...
June 29, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28664355/using-multiple-pharmacovigilance-models-improves-the-timeliness-of-signal-detection-in-simulated-prospective-surveillance
#12
Rolina D van Gaalen, Michal Abrahamowicz, David L Buckeridge
INTRODUCTION: Prospective pharmacovigilance aims to rapidly detect safety concerns related to medical products. The exposure model selected for pharmacovigilance impacts the timeliness of signal detection. However, in most real-life pharmacovigilance studies, little is known about which model correctly represents the association and there is no evidence to guide the selection of an exposure model. Different exposure models reflect different aspects of exposure history, and their relevance varies across studies...
June 29, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28664354/impact-of-medicine-withdrawal-on-reporting-of-adverse-events-involving-therapeutic-alternatives-a-study-from-the-french-spontaneous-reporting-database
#13
Cécile Pageot, Julien Bezin, Andy Smith, Mickael Arnaud, Francesco Salvo, Françoise Haramburu, Bernard Bégaud, Antoine Pariente
INTRODUCTION: The consequences of the withdrawal of marketing authorisation of drugs have mostly been studied considering drug prescription patterns for the therapeutic alternatives of the withdrawn drugs. The potential concomitant changes in the reporting of adverse reactions concerning these alternatives have been studied less often. OBJECTIVE: The objective of this study was to analyse the changes in the reporting of adverse events (AEs) for therapeutic alternatives after the withdrawal of three medicines (dextropropoxyphene, pioglitazone and tetrazepam) from the market for safety reasons...
June 29, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28653291/patients-perspectives-on-adverse-drug-reaction-reporting-in-a-developing-country-a-case-study-from-ghana
#14
George Tsey Sabblah, Delese Mimi Darko, Hudu Mogtari, Linda Härmark, Eugène van Puijenbroek
INTRODUCTION: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. OBJECTIVE: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana...
June 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28643174/natural-language-processing-for-ehr-based-pharmacovigilance-a-structured-review
#15
REVIEW
Yuan Luo, William K Thompson, Timothy M Herr, Zexian Zeng, Mark A Berendsen, Siddhartha R Jonnalagadda, Matthew B Carson, Justin Starren
The goal of pharmacovigilance is to detect, monitor, characterize and prevent adverse drug events (ADEs) with pharmaceutical products. This article is a comprehensive structured review of recent advances in applying natural language processing (NLP) to electronic health record (EHR) narratives for pharmacovigilance. We review methods of varying complexity and problem focus, summarize the current state-of-the-art in methodology advancement, discuss limitations and point out several promising future directions...
June 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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
#16
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
#17
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
#18
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
#19
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
#20
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
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