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Published in Charles E. Dean, The Skeptical Professional's Guide to Rational Prescribing, 2022
The debate continues, with Eguale et al.47 describing multiple examples of adverse drug events associated with off-label prescribing in a study of 46,000 adult patients and 150,000 new prescriptions, with data gathered over 6 years. Unfortunately, fewer than 20% of the off-label prescriptions were backed by strong evidence. Patients receiving these drugs were almost 55% more likely to have an adverse drug event. In a review of this study, Good and Gellad46 emphasize that clinicians often lack the time to assess the evidence behind off-label use, and thus may well lack the knowledge to accurately assess the risk–benefit ratio, making a balanced presentation to the patient difficult.
Preparing and administering sublingual allergen vaccines
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2020
Miguel Casanovas, Jonathan Kilimajer, Enrique Fernández-Caldas
SLIT use has attracted increasing interest in the United States. Physicians may use the allergen extract sublingually rather than subcutaneously, the formula of which is called off-label use. Off-label use means that the medication is being used in a manner not specified in the U.S. Food and Drug Administration's (FDA)-approved packaging label or insert [26,27]. Every prescription drug marketed in the United States carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA. However, most physicians are uncomfortable prescribing and compounding SLIT for their patients until the FDA approves the products. The main hurdles are related to the establishment of the optimal dose, the safety of a treatment administered at home, compliance issues, medical legal risk, and lack of billing codes. This subject has been recently reviewed [28].
Confessions from an insider
Published in Peter C. Gøtzsche, Richard Smith, Drummond Rennie, Deadly Medicines and Organised Crime, 2019
Peter C. Gøtzsche, Richard Smith, Drummond Rennie
It is illegal to market a drug for non-approved indications, so-called off-label use. As we shall see in the next chapter, illegal marketing is very common, and it is also routine that the companies circumvent the law. It is not illegal to discuss research results with doctors, and we could therefore show the film without breaking the law as long as we did not suggest to the doctors to use the drug for chronic bronchitis. If they had asked, we could say that we weren’t allowed to recommend the drug for this indication but that the results were interesting, and that the doctors were free to use drugs for whatever purpose they found reasonable. Absurdly, such indirect recommendations are not illegal. In my opinion, they should be. There is no good reason to present preliminary research results to practising clinicians; it is only reasonable to discuss them with academic researchers with the purpose of embarking on a definitive clinical trial hoping the new indication will be approved by the drug regulators.
College students’ comfort with and intention to use self-collection services for STI testing
Published in Journal of American College Health, 2022
Lisa L. Lindley, A’isha M. Sharif, Tasnuva Chowdhury
It is important to note that some of the tests we asked about in this investigation have not been cleared by the FDA for patient or home collection, and using them in this way is considered off-label use.9 Furthermore, we used the term “self-testing” throughout the survey without providing a definition of what these services are or which STIs could be tested via self-collection methods. This was done intentionally, in order to investigate students’ perceptions of these services. By doing so, however, it may have perpetuated the misperception that certain tests are available or that STI testing is a one-size-fits-all service that “tests for everything,” when it is (or should be) customized according to students’ risk factors. Future research on this topic should include definitions for “self-testing,” “express testing,” or “self-collection” services, explain which STIs can and cannot be tested via these methods, and specify that these services are only suitable for screening of asymptomatic individuals.
The use of off-label medications in substance abuse treatment programs
Published in Substance Abuse, 2020
Maria Paino, Lydia Aletraris, Paul M. Roman
While off-label use of medications is both legal and common, prescribing a medication for an indication that has not yet been FDA-approved usually occurs with little empirical evidence.41 Furthermore, pharmaceutical companies are prohibited from promoting a medication that is not FDA-approved; therefore, the public may be less aware that the medication can be used off-label. Nonetheless, practitioners should be aware of these medications, especially since they may reduce harm due to substance abuse and addiction if other treatments prove to be less successful for certain clients. Treatment centers that offer medications off-label may be in a position to offer education and training regarding efficacy and safety for the use of these medications. We recommend that SUD treatment centers offer their own lectures, or put seminar systems in place, to discuss the new possibilities in off-label medication use.
The Effect of Eplerenone in Chronic Central Serous Chorioretinopathy Refractory to Photodynamic Therapy
Published in Seminars in Ophthalmology, 2019
Dimitrios Karagiannis, Efstratios Parikakis, Loukas Kontomichos, Georgios Batsos, Irini Chatziralli
All patients underwent best corrected visual acuity (BCVA) measurement by means of Snellen charts, dilated fundoscopy and spectral domain-optical coherence tomography (SD-OCT), as well as FA using Heidelberg Spectralis (HRA+OCT, Heidelberg, Germany) at baseline, just before the intake of eplerenone. All participants were treated with oral eplerenone (Inspra, Pfizer) at a dose of 25 mg/day for 4 weeks and 50 mg/day thereafter for a total of 6-month treatment, if potassium levels were within normal limits at the beginning of week 5. Treatment was not continued after 6 months. The off-label use and potential risks and benefits were explained to all patients and written informed consent was obtained before entering the study. The study was in accordance with the Tenets of the Helsinki Declaration and was approved by the institutional review board of our hospital.