Spontaneous reporting of suspected narcolepsy after vaccination against pandemic influenza A (H1N1) in Germany
Sign Up to like & getrecommendations! Published in 2017 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4292
Abstract: We aimed at investigating whether, in Germany, the number of individual case safety reports (ICSR) of confirmed narcolepsy following Pandemrix® vaccination notified to the Paul‐Ehrlich‐Institut (PEI, German Federal Institute for Vaccines and Biomedicines) was higher… read more here.
Keywords: spontaneous reporting; narcolepsy vaccination; vaccination pandemic; suspected narcolepsy ... See more keywords
Adverse reactions related to proton pump inhibitors in pediatric population: an analysis of spontaneous reporting data.
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DOI: 10.1080/14740338.2021.1978975
Abstract: BACKGROUND The use of proton pump inhibitors (PPIs) has increased in the last ten years in children. Data regarding their safety profile are limited. The aim of this study was to analyze data from the… read more here.
Keywords: proton pump; pump inhibitors; spontaneous reporting; pediatric population ... See more keywords
Quo vadis (where are you going) pharmacovigilance?
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DOI: 10.1111/bcp.15584
Abstract: The goal of pharmacovigilance is to ensure that therapies are safe to use. The Hippocratic principle of do no harm (primum non nocere) forms the very foundation of pharmacovigilance. Pharmacovigilance systems are processes designed to… read more here.
Keywords: safety; world; clinical trials; spontaneous reporting ... See more keywords
Improving the spontaneous reporting of suspected adverse drug reactions; an overview of systematic reviews.
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DOI: 10.1111/bcp.15791
Abstract: AIM To conduct an overview of systematic reviews examining interventions to stimulate spontaneous reporting of suspected adverse drug reactions (ADRs) by HCPs and/or patients/carers METHODS: Systematic reviews published since January 1st , 2000, were identified… read more here.
Keywords: systematic reviews; reporting suspected; suspected adverse; reporting ... See more keywords
Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach
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DOI: 10.1177/1177932220921350
Abstract: The efficacy and safety of herbal supplements suffer from challenges due to non-uniform representation of ingredient terms within biomedical and observational health data sources. The nature of how supplement data are reported within Spontaneous Reporting… read more here.
Keywords: resolution; spontaneous reporting; reporting systems; adverse events ... See more keywords
Immune Checkpoint Inhibitors and Pregnancy: Analysis of the VigiBase® Spontaneous Reporting System
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DOI: 10.3390/cancers15010173
Abstract: Simple Summary In preclinical studies, it has been shown that the blockade of immune checkpoint pathways increases the risk of fetal death. Therefore, the use of immune checkpoint inhibitors (ICIs) in cancer patients who are… read more here.
Keywords: reporting system; checkpoint inhibitors; immune checkpoint; spontaneous reporting ... See more keywords