ArticleJACC. Basic to translational science2023
Off-Label Use vs Off-Label Marketing of Drugs: Part 1: Off-Label Use-Patient Harms and Prescriber Responsibilities.
Article in JACC. Basic to translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed.
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- Panitumumab-Based EGFR Blockade in SMARCB1-Deficient Renal Medullary Carcinoma: Preclinical Basis and Prospective Clinical Activity.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Genetically supported drug target prioritization for rare diseases.Genome medicine · 2026Article
- Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence.iScience · 2026Article
- Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan.Journal of medical systems · 2026Article
- A prospective observational study on the off-label use of medications in the psychiatry outpatient department of a tertiary care hospital.Indian journal of pharmacology · 2026Observational
- Development of tenecteplase for stroke thrombolysis: Japan's endeavor.Hypertension research : official journal of the Japanese Society of Hypertension · 2026Review
- Prevalence of use and interest in using glucagon-like peptide-1 receptor agonists for weight loss: a population study in Great Britain.BMC medicine · 2026Article
- Medicines, Diseases, Indications, and Contraindications (MeDIC): a foundational resource to support drug repurposing.Nucleic acids research · 2026Article
- Approaches to ketamine-assisted couple therapy.Frontiers in psychology · 2026Article
- Identification of therapeutic targets for renal medullary carcinoma via integrated genomic and transcriptomic profiling.Cell reports. Medicine · 2025Article
- Drug Repurposing in Veterinary Oncology: Myth or Reality?Veterinary sciences · 2025Review
- Utilization of Ciprofloxacin-Dexamethasone in the Airway: A Scoping Review.The Laryngoscope · 2025Article
- The Expanding Role of Omalizumab: From Food Allergy to Drug Desensitization.International journal of molecular sciences · 2025Review
- Therapeutic Potential of Calcium Channel Blockers in Neuropsychiatric, Endocrine and Pain Disorders.Cells · 2025Review
- Individualized and innovative gender healthcare for transgender and nonbinary youth.Nature reviews. Endocrinology · 2025Review
- Ethical considerations in AI for child health and recommendations for child-centered medical AI.NPJ digital medicine · 2025Review
- AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.The AAPS journal · 2025Article
- Pioneering a new field of computational pharmacophenomics to unlock the life-saving potential of existing medicines.The Lancet. Haematology · 2025Article
- Off-label Prescribing of Clozapine and Safety.Turk psikiyatri dergisi = Turkish journal of psychiatry · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. Part 1 of this review focuses on off-label use of FDA-approved therapies. Part 2 addresses illegal off-label marketing of drugs and devices. While off-label use can be beneficial to patients, unless carefully undertaken off label use may undermine the important safety mission of the FDA, can expose patients to elevated risks without proven benefits (or possibly no benefit), and can reduce motivation of companies to study the safety and risks of off-label use of therapies. These problems are further amplified when off-label use occurs among very vulnerable patient populations such as the elderly, patients with mental health disorders, pregnant women and pediatric patients. This review considers ethical issues in off-label use, as well as important steps for physicians considering an off-label prescription of a drug or device.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.