Article
Cardiac & Cardiovascular Systems
Gail A. Van Norman
Summary: 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. This review discusses the off-label use of FDA-approved therapies, the illegal off-label marketing of drugs and devices, and the potential risks and ethical issues associated with off-label use.
JACC-BASIC TO TRANSLATIONAL SCIENCE
(2023)
Article
Medicine, General & Internal
Amanda Katherina Herbrand, Andreas M. Schmitt, Matthias Briel, Hannah Ewald, Marius Goldkuhle, Stefan Diem, Anouk Hoogkamer, Markus Joerger, Giusi Moffa, Urban Novak, Lars G. Hemkens, Benjamin Kasenda
Summary: In the Swiss health system, off-label use of anticancer drugs is often intended as a first-line treatment and evidence from randomized clinical trials showing survival benefits was not associated with reimbursement decisions. Transparent criteria considering clinical evidence are needed for fair access to cancer treatments.
Article
Pharmacology & Pharmacy
Min Meng, Qi Zhou, Wenjuan Lei, Min Tian, Ping Wang, Yunlan Liu, Yajia Sun, Yaolong Chen, Qiu Li
Summary: This study systematically analyzed the supporting evidence, drug information, and type of off-label drug use in pediatric guidelines, finding gaps in reporting and evidence of off-label drug use recommendations that could expose children to medical risks.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Nutrition & Dietetics
Min-Yen Chang, Han-Shen Chen
Summary: This study explores consumer needs for food clean label certification and compares them with previous research. The results indicate that consumer involvement and product knowledge significantly influence their purchase intention. The study suggests enhancing consumer knowledge of food security and provides crucial insights for marketing channels.
Article
Pharmacology & Pharmacy
Soojin Lee, Mi Hee Yang, Jung Sun Kim, Yoonsuk Cho, Nigh Choi, Eun Jung Cho, June Dong Park, Yu Hyeon Choi, Kyung Hee Choi
Summary: This study retrospectively analyzed electronic medical data from a pediatric intensive care unit in Korea and found that 96.0% of medications used were off-label. The department of the patient, total number of medications, and length of hospital stay were significantly associated with adverse drug reactions.
SAUDI PHARMACEUTICAL JOURNAL
(2023)
Article
Gastroenterology & Hepatology
Nanne K. H. de Boer, Melek Simsek, Berrie Meijer, Markus F. Neurath, Ad van Bodegraven, Chris J. J. Mulder
Summary: Drug rediscovery refers to the principle of using 'old' drugs outside their original indications. This study focuses on the rediscovery of thioguanine (TG) in the treatment of inflammatory bowel disease in the Netherlands and highlights the global need for optimal use and development of potentially useful drugs. The paper also provides an overview of the registration process for TG, aiming to guide future drug rediscovery efforts.
Article
Pharmacology & Pharmacy
Guoxu Wei, Min Wu, He Zhu, Sheng Han, Jing Chen, Chenchen Zhai, Luwen Shi
Summary: This study quantified and characterized the off-label (OL) use of antineoplastic drugs for treating malignancies in China. Results showed that OL use was prevalent, with uncommon malignancies more likely to be treated in this manner. Furthermore, commonly used antineoplastic drugs were more likely to be used off-label.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Gastroenterology & Hepatology
Amol Agarwal, Talan Zhang, Nishal Ravindran, Paul J. Thuluvath, Anurag Maheshwari
Summary: The off-label use of multitarget stool DNA (mt-sDNA) testing is common in primary care settings, with increasing age being associated with off-label orders. Further efforts are needed to educate patients and providers on the appropriate use of mt-sDNA for colorectal cancer screening.
AMERICAN JOURNAL OF GASTROENTEROLOGY
(2021)
Review
Pharmacology & Pharmacy
Tjitske M. van der Zanden, Nori J. L. Smeets, Marika de Hoop-Sommen, Michiel F. T. Schwerzel, Hui Jun Huang, Lieke J. C. Barten, Joyce E. M. van der Heijden, Jolien J. M. Freriksen, Akira A. L. Horstink, Inge H. G. Holsappel, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt
Summary: A comprehensive overview of the quality of evidence for off-label drug use in children is lacking. The Dutch Pediatric Formulary provides evidence-based dosing guidelines, but most off-label drug records lack high quality evidence. This severely limits drug treatment options for children.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Review
Pediatrics
Min Meng, Meng Lv, Ling Wang, Bo Yang, Panpan Jiao, Wenjuan Lei, Hui Lan, Quan Shen, Xufei Luo, Qi Zhou, Xuan Yu, Yangqin Xun, Ruobing Lei, Tianchun Hou, Yaolong Chen, Qiu Li
Summary: This study aimed to explore the current state of research on off-label drug use in children and identify research gaps in this area. The findings showed that antipsychotic agents were the most commonly reported drug type for off-label use in children. It is suggested that pediatric researchers consider the number of studies on off-label use and existing clinical trials on different drugs when selecting target drugs for new studies.
EUROPEAN JOURNAL OF PEDIATRICS
(2022)
Editorial Material
Chemistry, Multidisciplinary
Christopher R. Fullenkamp, John S. Schneekloth
Summary: A new method has been developed to map and characterize the interactions between small-molecule drugs and RNA in cells, shedding light on the functional effects of these interactions.
Article
Psychiatry
Davide Fortin, Vincent Di Beo, Sophie Massin, Yann Bisiou, Patrizia Carrieri, Tangui Barre
Summary: This study examined the motives for using CBD to reduce cannabis consumption and the factors associated with successful reduction. The results showed that smoking cigarettes and drinking alcohol were correlated with using CBD to reduce cannabis consumption. Among those who used CBD-rich cannabis for smoking, 58.7% reported a large reduction in cannabis consumption, which was associated with non-daily cannabis use and daily CBD use.
FRONTIERS IN PSYCHIATRY
(2022)
Review
Medicine, General & Internal
Emanuela Del Giudice, Jurgen Sota, Francesca Orlando, Ludovica Picciano, Rolando Cimaz, Luca Cantarini, Angela Mauro
Summary: The off-label use of canakinumab has shown excellent efficacy and safety in pediatric patients with various rare diseases and immune-mediated disorders.
FRONTIERS IN MEDICINE
(2022)
Article
Pharmacology & Pharmacy
Kholoud Bastaki, Mohammed El Anbari, Suhaila Ghuloum, Puthen Veettil Jithesh
Summary: The study evaluated the prescription pattern and off-label use of antipsychotics in the Qatari population, revealing a high prevalence of off-label prescriptions for non-mental health conditions among Qatari patients, particularly for controlling chronic diseases and sleeping disorders. Female patients were the majority consumers of antipsychotics, with second-generation antipsychotics like quetiapine and olanzapine being the most commonly prescribed drugs.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Cardiac & Cardiovascular Systems
Nicolas Werner, Matthias Renker, Oliver Dorr, Timm Bauer, Holger Nef, Yeong-Hoon Choi, Christian W. Hamm, Ralf Zahn, Won-Keun Kim
Summary: The study found that around 20% of transcatheter aortic valve replacement procedures involved off-label use of THV based on anatomical considerations, while 16.3% involved implantation of a clinically unsuitable THV. Clinical suitability and adherence to instructions for use varied across different THV systems, but did not affect procedural outcomes.
INTERNATIONAL JOURNAL OF CARDIOLOGY
(2022)