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Off-Label Use vs Off-Label Marketing of Drugs
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 +4 more sources
Antipsychotic off-label use in the 21st century: An enduring public health concern [PDF]
Soon 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
Metabolic adverse effects of off-label use of second-generation antipsychotics in the adult population: a systematic review and meta-analysis [PDF]
Nicolette Stogios +9 more
openalex +2 more sources
Using Twitter data to understand public perceptions of approved versus off-label use for COVID-19-related medications [PDF]
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 Tenecteplase for the Treatment of Acute Ischemic Stroke
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
Intravenous thrombolysis (IVT) represents the only systemic reperfusion therapy able to reverse neurological deficit in patients with acute ischemic stroke (AIS).
G. Tsivgoulis +13 more
semanticscholar +1 more source
Management guideline for the off-label use of medicine in China (2021)
Background Off-label drug use embodies a thorough clinical diagnosis and evaluation of treatment needs and should not be confused with unreasonable drug use, but it also faces potential risks with drug safety and legal issues. Research design and methods
W. Zuo +18 more
semanticscholar +1 more source
Off-label antineoplastic drugs. An effectiveness and safety study [PDF]
Objective: The use of antineoplastic medicines in special situations is common in clinical practice; it is strongly regulated and there is little information on its outcomes.
Cristina Arroyo Álvarez +5 more
doaj +1 more source
Introduction: Most of the antibiotics currently used in pediatrics are either unlicensed or being prescribed outside the specifications of product label (off-label prescribing).
Muhammad Hafeez +6 more
doaj +1 more source
Off-Label Drug Use in Oncology
The off-label use of medicines is a routine clinical practice of oncology, especially in malignant-tumour patients with no treatment alternatives left when registered-drug options have been exhausted or standard therapies reveal contraindications.
E. V. Karabina +2 more
doaj +1 more source

