Tocilizumab in rheumatoid arthritis: A case study of safety evaluations of a large postmarketing data set from multiple data sources [PDF]
, 2015 ObjectivesTo evaluate the magnitude of serious adverse events (SAEs) observed in postmarketing reports of tocilizumab (TCZ) for rheumatoid arthritis (RA) in relation to SAEs observed in TCZ clinical trials and external epidemiology data.MethodsA total of
Curtis, Jeffrey R. +6 more
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Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]
, 2010 Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y. +3 more
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Physicians' Experiences as Patients with Statin Side Effects: A Case Series. [PDF]
, 2017 Physicians are among those prescribed statins and therefore, subject to potential statin adverse effects (AEs). There is little information on the impact of statin AEs on physicians affected by them. We sought to assess the character and impact of statin
Golomb, Beatrice Alexandra +2 more
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Journal of Rheumatology, 2020 Objective. To assess the long-term safety and effectiveness of tacrolimus for treating lupus nephritis (LN) in the real-world clinical setting. Methods.
T. Takeuchi +3 more
semanticscholar +1 more source
Effectiveness of drug postmarketing all-case surveillance as a safety measure in Japan
Therapeutic Advances in Drug Safety, 2021 Introduction: The drug pharmacovigilance system in Japan is similar to those in the European Union (EU) and the United States. As a unique Japanese pharmacovigilance program, postmarketing all-case surveillance (PMACS) is required. PMACS plays a key role
Hideyuki Kondo, Ken Masamune
semanticscholar +1 more source
The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements [PDF]
, 2018 The United States Food and Drug Administration (FDA) has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs
Naci, Huseyin +2 more
core +1 more source
Scientific Reports, 2021 Randomized controlled trials (RCTs) have shown an antidepressant effect of glabellar botulinum toxin (BoNT) injections. In the FDA Adverse Event Reporting System (FAERS) database, BoNT injection is associated with reduced incidence rates of depression ...
M. A. Wollmer +3 more
semanticscholar +1 more source
Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians [PDF]
, 2014 Peer reviewedPublisher ...
Bond, Christine M +4 more
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The critical need for postmarketing surveillance in gene therapy for haemophilia
Haemophilia, 2020 The goal of gene therapy for haemophilia is to alter the clinical phenotype to a milder form or even cure, by increasing endogenous coagulation factor levels through transfer of a functional gene encoding the respective deficient coagulation factor and ...
B. Konkle, M. Recht, A. Hilger, P. Marks
semanticscholar +1 more source
Improving the external validity of clinical trials: the case of multiple chronic conditions [PDF]
, 2013 The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will ...
Fortin, Martin, Smith, Susan M.
core +4 more sources