ReviewInternational journal of environmental research and public health2021
Off-Label Medication: From a Simple Concept to Complex Practical Aspects.
Review in International journal of environmental research and public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.
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
30 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Thematic mapping of off-label prescription in psychiatry and its implications for bioethics, human rights, and clinical practice: a scoping review.Frontiers in psychiatry · 2026Pooled it
- Pediatric Use of Off-Label Medicines and Nonevidence-Based Supplements for COVID-19: Findings From the 2015 Pelotas Birth Cohort Study (Brazil).Pharmacoepidemiology and drug safety · 2026Article
- Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence.iScience · 2026Article
- Off-Label Treatment of Alopecia Areata-Retrospective Study.Biomedicines · 2026Article
- Off-label prescribing in ophthalmology: a retrospective analysis.Frontiers in pharmacology · 2026Article
- Psychotropic Medications for Non-Psychiatric Conditions: A Narrative Review.Healthcare (Basel, Switzerland) · 2025Review
- Health-related quality of life and productivity burden for non-professional caregivers of adults with rare diseases: a real-world study.Orphanet journal of rare diseases · 2025Article
- Evaluation of Diagnostic Recommendations Embedded in Medication Alerts: Prospective Single-Arm Interventional Study.Journal of medical Internet research · 2025Article
- Off-Label Treatment in Inflammatory Skin Diseases-European Point of View.Journal of clinical medicine · 2025Review
- Mapping the therapeutic versatility of WHO essential medicines: a systematic analysis of off-label indications.Therapeutic advances in drug safety · 2025Article
- ["How to get your Doxy-PEP?": vulnerabilities and critical routes encountered by men in the therapeutic itinerary in Brazil].Cadernos de saude publica · 2025Article
- Mydriasis mediated by local anesthetics: an unexpected adverse event or new therapeutic indication?Therapeutic advances in drug safety · 2025Review
- Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study.Pharmacy (Basel, Switzerland) · 2024Article
- Barriers and facilitators to guideline for the management of pediatric off-label use of drugs in China: a qualitative descriptive study.BMC health services research · 2024Article
- Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials: Human-Centered Design Approach.JMIR formative research · 2024Article
- Phase I Safety and Feasibility Pilot of Hepatic Artery Infusion Chemotherapy in a Rural Catchment Area Using The Codman Vascular Catheter with The Medtronic SynchroMed II Pump for Intrahepatic Cancers.Annals of surgical oncology · 2024Article
- Estimating Type 2 Diabetes Prevalence: A Model of Drug Consumption Data.Pharmacy (Basel, Switzerland) · 2024Article
- Off-Label Immunosuppressant Drugs in Solid Organ Transplantation.Pharmacy (Basel, Switzerland) · 2024Review
- Ethanol Inhalation as a Method to Denature the Spike Protein of SARS-CoV-2.Advances in experimental medicine and biology · 2024Article
- The real-world safety of oseltamivir and baloxavir marboxil in children: a disproportionality analysis of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet clinical needs. Several therapeutic areas require off-label approaches; therefore, this practice is challenging for prescribing physicians. Meanwhile, the regulatory agencies are making efforts in order to ensure a safe practice. The present paper defines the off-label concept, and it describes its regulation, together with several complex aspects associated with clinical practices regarding rare diseases, oncology, pediatrics, psychiatry therapeutic areas, and the safety issues that arise. A systematic research of the literature was performed, using terms, such as "off-label", "prevalence", "rare diseases", "oncology", "psychiatry", "pediatrics", and "drug repurposing". There are several reasons for which off-label practice remains indispensable in the present; therefore, efforts are made worldwide, by the regulatory agencies and governmental bodies, to raise awareness and to ensure safe practice, while also encouraging further research.
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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.