Association Between Data Sources and US Food and Drug Administration Drug Safety Communications.
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DOI: 10.1001/jamainternmed.2019.3066
Abstract: Association Between Data Sources and US Food and Drug Administration Drug Safety Communications Drug safety communications (DSCs) are the primary tool for the US Food and Drug Administration (FDA) to communicate important new postmarketing safety… read more here.
Keywords: safety communications; safety; drug administration; drug ... See more keywords
Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem‐containing medications
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DOI: 10.1002/pds.4215
Abstract: Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next‐morning impairment and recommending lower starting doses particularly for women. This study aimed to… read more here.
Keywords: zolpidem; drug safety; changes prescribing; safety communications ... See more keywords
Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database
Sign Up to like & getrecommendations! Published in 2018 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4623
Abstract: Postmarketing drug safety surveillance relies upon measures of disproportionate reporting in spontaneous reporting systems. It has been hypothesized that products or events reported frequently may “mask” signals. read more here.
Keywords: masking vaccines; drug; drug safety; vaccines pediatric ... See more keywords
Establishment of the MID‐NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan
Sign Up to like & getrecommendations! Published in 2019 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4879
Abstract: To establish a new medical information database network (designated MID‐NET®) to provide real‐world data for drug safety assessments in Japan. read more here.
Keywords: medical information; drug safety; information database; database ... See more keywords
Empirical assessment of case‐based methods for drug safety alert identification in the French National Healthcare System database (SNDS): Methodology of the ALCAPONE project
Sign Up to like & getrecommendations! Published in 2020 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4983
Abstract: To introduce the methodology of the ALCAPONE project. read more here.
Keywords: methodology alcapone; methodology; drug safety; alcapone project ... See more keywords
Impact of a drug safety communication on the severity of benzonatate exposures reported to poison centers
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DOI: 10.1002/pds.5136
Abstract: Identify if publication of the 2010 drug safety communication (DSC) regarding benzonatate was associated with a decrease in the incidence of severe benzonatate poisonings reported to United States poison centers. read more here.
Keywords: poison centers; drug; benzonatate; drug safety ... See more keywords
Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review
Sign Up to like & getrecommendations! Published in 2022 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5548
Abstract: Signal detection is a crucial step in the discovery of post‐marketing adverse drug reactions. There is a growing interest in using routinely collected data to complement established spontaneous report analyses. This work aims to systematically… read more here.
Keywords: routinely collected; signal detection; drug safety; drug ... See more keywords
Detection of drug safety signal of drug‐induced neutropenia and agranulocytosis in all‐aged patients using electronic medical records
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DOI: 10.1002/pds.5559
Abstract: We explored the adverse drug reaction signals of drug‐induced neutropenia (DIN) and drug‐induced agranulocytosis (DIA) in hospitalized patients and evaluated the novelty of these correlations. read more here.
Keywords: drug induced; detection drug; induced neutropenia; drug safety ... See more keywords
Federated analyses of multiple data sources in drug safety studies
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DOI: 10.1002/pds.5587
Abstract: Studies of rare side effects of new drugs with limited exposure may require pooling of multiple data sources. Federated Analyses (FA) allow real‐time, interactive, centralized statistical processing of individual‐level data from different data sets without… read more here.
Keywords: data sources; drug safety; multiple data; federated analyses ... See more keywords
The assessment of drug safety for the fetus
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DOI: 10.1007/s11096-020-01132-y
Abstract: Long standing concerns regarding the use of medications during pregnancy and their unknown effects on fetal development and child health suggests the need for modified study methods regarding the establishment of drug safety for the… read more here.
Keywords: drug safety; assessment drug; safety fetus;
Drug Safety Analysis in a Real-Life Cohort of Parkinson’s Disease Patients with Polypharmacy
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DOI: 10.1007/s40263-017-0478-0
Abstract: BackgroundPolypharmacy is common in geriatric Parkinson’s disease (PD) patients in advanced disease stages with multiple comorbidities, bearing multiple risks for drug safety in theory.ObjectiveThe aim of this study was to empirically identify the most frequent… read more here.
Keywords: disease patients; drug; drug safety; parkinson disease ... See more keywords