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
Pharmacology & Pharmacy
Lucia Gozzo, Calogero Vetro, Serena Brancati, Laura Longo, Daniela Cristina Vitale, Giovanni Luca Romano, Elisa Mauro, Paolo Fabio Fiumara, Cinzia Maugeri, Marina Silvia Parisi, Ilaria Dulcamare, Bruno Garibaldi, Andrea Duminuco, Giuseppe Alberto Palumbo, Francesco Di Raimondo, Filippo Drago
Summary: This study collected real-world data on patients treated with VEN + HMAs in Italian hospitals and found significant efficacy of the combination therapy in patients with no adequate therapeutic options, but also a high rate of adverse drug reactions, including serious infections and hematological toxicities.
FRONTIERS IN PHARMACOLOGY
(2021)
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
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
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
Medicine, General & Internal
Aristeidis H. Katsanos, Klearchos Psychogios, Guillaume Turc, Simona Sacco, Diana Aguiar de Sousa, Gian Marco De Marchis, Lina Palaiodimou, Dimitrios K. Filippou, Niaz Ahmed, Amrou Sarraj, Bijoy K. Menon, Georgios Tsivgoulis
Summary: Evidence from nonrandomized studies suggests that tenecteplase is as safe as alteplase and potentially associated with improved functional outcomes compared with alteplase.
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)
Article
Veterinary Sciences
Saeyoung Lee, Woo-Jin Song, Jongjin Park, Minkun Kim, Sangkyung Choen, Myung-Chul Kim, Hyohoon Jeong, Youngmin Yun
Summary: Crisdesalazine is a multi-targeted drug used to prevent dementia by targeting amyloid plaque, neurofibrillary tangle, and neurodegeneration. It showed additional therapeutic effects in canine meningoencephalitis of unknown origin (MUO) patients.
VETERINARY SCIENCES
(2023)
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
Psychiatry
M. Hojlund, J. H. Andersen, K. Andersen, C. U. Correll, J. Hallas
Summary: Over one-third of antipsychotic users in Denmark did not have psychiatric, neurological or cancer diagnoses as possible indications for antipsychotic therapy. Many antipsychotics are initiated or prescribed in general practice, and a concerningly large subgroup without documented diagnoses relevant for antipsychotics continued to receive them. Rational prescribing, adequate side effect monitoring and further research into reasons for the observed antipsychotic use patterns and their risk-benefit ratio are needed.
EPIDEMIOLOGY AND PSYCHIATRIC SCIENCES
(2021)
Article
Pharmacology & Pharmacy
Guangyao Li, Ningli Wang, Yu Zhang, Wenbin Wei, Hai Lu, Suodi Zhai, Chao Zhang
Summary: This article discusses the widespread use of off-label drugs in ophthalmology in China and the safety issues associated with inappropriate use. To guide the use of these off-label drugs, the authors developed an evidence-based guideline using systematic reviews and meta-analyses to synthesize scientific evidence, and employed the GRADE approach to assess the quality of evidence and grade the strength of recommendations.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Cardiac & Cardiovascular Systems
So-Ryoung Lee, Eue-Keun Choi, Sang-Hyun Park, Jin-Hyung Jung, Kyung-Do Han, Seil Oh, Gregory Y. H. Lip
Summary: In Asian patients with atrial fibrillation, off-label underdosed apixaban use without meeting dose reduction criteria was associated with higher risks of ischemic stroke and all-cause death compared to on-label standard dose apixaban use.
EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
(2021)
Article
Dermatology
Niina Kleiber, Laurence Gariepy-Assal, Jerome Coulombe, Simon Marcoux, Sandrine Essouri, Catherine McCuaig, Julie Powell, Gilles Soulez, Josee Dubois
Summary: Off-label drug use is common in the management of vascular anomalies (VA) and poses significant safety concerns, with 98.9% of drugs used off-label. Only one drug, the oral solution of propranolol hydrochloride (Hemangeol (R)), is approved for use in VA. Safety issues are more prevalent in systemic drugs compared to locally delivered drugs, emphasizing the importance of carefully weighing risks and benefits when using these treatments.
Review
Critical Care Medicine
Ayman A. Hussein, Paulino Alvarez, Grant Reed, Gustavo A. Heresi
Summary: This article reviews the evidence and current off-label use of direct oral anticoagulants in various cardiopulmonary disease states.
Article
Agriculture, Dairy & Animal Science
Hikmet Un, Nihat Yumusak, Irfan Ozgunluk, Rahsan Yilmaz, Mehmet Cabalar
INDIAN JOURNAL OF ANIMAL RESEARCH
(2019)
Article
Radiology, Nuclear Medicine & Medical Imaging
Rahsan Yilmaz, Nihat Yumusak, Murat Sadic, Hasan I. Atilgan, Meliha Korkmaz, Faruk Bozkaya
NUCLEAR MEDICINE COMMUNICATIONS
(2018)
Article
Veterinary Sciences
Aylin Alasonyalilar Demirer, Ahmet Akkoc, Bayram Senlik, Taci Cangul
TURKISH JOURNAL OF VETERINARY & ANIMAL SCIENCES
(2018)
Article
Food Science & Technology
Ali Sorucu, Hasan Huseyin Oruc
JOURNAL OF FOOD MEASUREMENT AND CHARACTERIZATION
(2019)
Article
Anatomy & Morphology
Bestami Yilmaz, Ismail Demircioglu, Deniz Korkmaz, Aydin Alan, Rahsan Yilmaz, Abdulkadir Ciris
Summary: The study examined the structure of the pecten oculi in Northern Bald Ibises for the first time, revealing similarities to other diurnal bird species with accordion-like pleats, abundant blood vessels, and melanocytes. The pecten had 13-14 pleats and a bridge with stronger pigmentation at the apical part. Overall, the general morphology of the pecten oculi in Northern Bald Ibises was found to be comparable to that in other migratory bird species.
ANATOMIA HISTOLOGIA EMBRYOLOGIA
(2021)
Article
Entomology
Hasan Huseyin Oruc, Meltem cayci, Ali Sorucu, Ender Uzabaci, Ramadhan Nyandwi
Summary: Propolis, with its high content of phenolic compounds, possesses various beneficial properties that make it suitable for human consumption and medicinal purposes. This study analyzed the concentrations of sixteen phenolic compounds in local and imported raw propolis and propolis products in Turkey. The results showed variations in the concentrations of individual phenolic compounds across different propolis samples, as well as significant differences between local and imported samples.
JOURNAL OF APICULTURAL RESEARCH
(2023)
Article
Veterinary Sciences
N. Yumusak, A. Yigin, P. F. Polat, M. Hitit, R. Yilmaz
POLISH JOURNAL OF VETERINARY SCIENCES
(2018)
Article
Veterinary Sciences
F. Temamogullari, F. Aral, R. Yilmaz
POLISH JOURNAL OF VETERINARY SCIENCES
(2018)
Article
Agriculture, Multidisciplinary
B. Yilmaz, R. Yilmaz, I. S. Harem, I Demircioglu
Summary: Through histological and immunohistochemical methods, this study identified four types of nerve endings in the shoulder and elbow joint capsule of gazelles, with more mechanoreceptors detected in the elbow joint compared to the shoulder joint. This suggests a strong innervation in the shoulder and elbow joint capsule of gazelles, potentially contributing to their fast and nimble movement ability.
JOURNAL OF ANIMAL AND PLANT SCIENCES-JAPS
(2021)
Article
Entomology
Hasan H. Oruc, Meltem Cayci, Rashad Sariyev
JOURNAL OF APICULTURAL SCIENCE
(2020)
Article
Agriculture, Multidisciplinary
Mehmet Cetin, Sabri Yurtseven, Abdurrahim Kocyigit, Ftisun Temamogullari, Mehtap Gul Altas, Zafer Ozyildiz, Rahsan Yilmaz, Abdullah Taskin
KSU TARIM VE DOGA DERGISI-KSU JOURNAL OF AGRICULTURE AND NATURE
(2019)
Article
Medicine, General & Internal
I. Duzen, E. Oguz, R. Yilmaz, A. Taskin, E. Vuruskan, Y. Cekici, Z. G. Bilgel, H. Goksuluk, B. Candemir, M. Sucu
BRATISLAVA MEDICAL JOURNAL-BRATISLAVSKE LEKARSKE LISTY
(2019)
Meeting Abstract
Radiology, Nuclear Medicine & Medical Imaging
N. Yumusak, A. Yigin, H. Atilgan, A. Kalayci Yigin, G. Koca, R. Yilmaz, M. Korkmaz
EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING
(2019)
Article
Veterinary Sciences
Ayse Topal, Nihal Y. Gul Satar, I. Taci Cangul, M. Ayberk Oktay, Kivanc Inan, Goksen Cecen, E. Pinar Akarsu, Hakcahan Can
ACTA VETERINARIA BRNO
(2018)
Article
Veterinary Sciences
Yilmaz Rahsan, Yumusak Nihat, Yilmaz Bestami, Ayan Adnan, Aysul Nuran
JOURNAL OF VETERINARY RESEARCH
(2018)
