Off-Label Use vs Off-Label Marketing of Drugs
JACC: Basic to Translational Science, 2023 Once medical drugs and devices are approved for marketing by the FDA they can legally be used for purposes and in ways other than the ones for which they have been tested and approved. However, it is illegal for manufacturers to advertise or promote such unapproved uses of the drugs and devices.
Gail A. Van Norman
semanticscholar +5 more sources
Outcomes of off-label drug uses in hospitals: a multicentric prospective study [PDF]
, 2014 Purpose: The study aims to assess the clinical evidence, outcome and cost of off-label use of medicines in the hospital setting. Methods: A multicentric prospective cohort study of patients treated with off-label medicines was carried out in five ...
Imma Danés +12 more
openalex +3 more sources
Efficacy of Off-Label Use of Anticancer Drugs in Oncology
Креативная хирургия и онкология, 2023 The off-label use of anticancer drugs is widespread in modern oncology. The potential advantages of such prescriptions are associated with exceeding the expected clinical benefi ts over the risks of complications.
E. V. Karabina +2 more
doaj +3 more sources
Off-label use of orphan medicinal products: a Belgian qualitative study [PDF]
Orphanet Journal of Rare Diseases, 2016 Background Off-label use of (orphan) medicinal products for (rare) diseases is quite common but not underpinned by clinical studies to confirm efficacy and safety. No risk-analyses by regulatory agencies are carried out.
Marc Dooms +2 more
doaj +2 more sources
The off-label use of anakinra in pediatric systemic autoinflammatory diseases [PDF]
Therapeutic Advances in Musculoskeletal Disease, 2020 Interleukin 1 (IL-1), a central mediator of innate immunity, is considered a master cytokine of local and systemic inflammation. IL-1 has emerged as pivotal in the pathogenesis of autoinflammatory diseases (AIDs), and blockade of its pathway has become a
Valerio Maniscalco +6 more
openalex +2 more sources
Antipsychotic off-label use in the 21st century: An enduring public health concern [PDF]
Dialogues in Clinical NeuroscienceSoon after the introduction of second-generation antipsychotics, antipsychotic off-label use (OLU) progressively became a common prescribing practice. This evolving practice should be regularly monitored considering the growing number of persons exposed ...
Hélène Verdoux
doaj +2 more sources
Using Twitter data to understand public perceptions of approved versus off-label use for COVID-19-related medications [PDF]
J. Am. Medical Informatics Assoc., 2022 Objective Understanding public discourse on emergency use of unproven therapeutics is essential to monitor safe use and combat misinformation. We developed a natural language processing-based pipeline to understand public perceptions of and stances on ...
Y. Hua +6 more
semanticscholar +1 more source
Off-Label Use of Topical Ruxolitinib in Dermatology: A Systematic Literature Review and Current Perspectives. [PDF]
Exp DermatolSpadafora M +5 more
europepmc +3 more sources
MoDorado: enhanced detection of tRNA modifications in nanopore sequencing by off-label use of modification callers. [PDF]
Nucleic Acids ResRübsam FNM +8 more
europepmc +3 more sources
Off-Label Use of Tenecteplase for the Treatment of Acute Ischemic Stroke
JAMA Network Open, 2022 Key Points Question How does the use of tenecteplase compare with the use of alteplase in the clinical outcomes of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis?
A. Katsanos +11 more
semanticscholar +1 more source