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      Ten Common Questions (and Their Answers) About Off-label Drug Use

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      Mayo Clinic Proceedings
      Elsevier BV

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          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.

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          Author and article information

          Journal
          Mayo Clinic Proceedings
          Mayo Clinic Proceedings
          Elsevier BV
          00256196
          October 2012
          October 2012
          : 87
          : 10
          : 982-990
          Article
          10.1016/j.mayocp.2012.04.017
          3538391
          22877654
          0eac44c3-3cbe-4de2-84e2-c6c3f187ab5d
          © 2012

          https://www.elsevier.com/tdm/userlicense/1.0/

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