Ten common questions (and their answers) about off-label drug use
- PMID: 22877654
- PMCID: PMC3538391
- DOI: 10.1016/j.mayocp.2012.04.017
Ten common questions (and their answers) about off-label drug use
Abstract
The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education exercises, and the media. Yet, we propose that many health care professionals have an underappreciation of its definition, prevalence, and implications. This article introduces and answers 10 questions regarding OLDU in an effort to clarify the practice's meaning, breadth of application, acceptance, and liabilities. Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient. In addition, health care professionals should educate themselves about OLDU to weigh the risks and benefits and provide the best possible care for their patients.
Copyright © 2012 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
Comment in
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Off-label drug use: the bevacizumab story.Mayo Clin Proc. 2013 Mar;88(3):305. doi: 10.1016/j.mayocp.2012.12.007. Epub 2013 Feb 27. Mayo Clin Proc. 2013. PMID: 23489456 No abstract available.
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In reply.Mayo Clin Proc. 2013 Mar;88(3):305-6. doi: 10.1016/j.mayocp.2012.12.008. Epub 2013 Feb 27. Mayo Clin Proc. 2013. PMID: 23489457 No abstract available.
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