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

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Wittich, Christopher M., Burkle, Christopher M., Lanier, William L.·2012·Mayo Clinic Proceedings

DOI 10.1016/j.mayocp.2012.04.017PMC PMC3538391

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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.

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Authors: Wittich, C. M., Burkle, C. M., & Lanier, W. L.
Affiliations: Mayo Clinic (US)
Corresponding author: Wittich, Christopher M.
ORCID: Wittich, Christopher M.
Burkle, Christopher M.
Lanier, William L.
Venue: Mayo Clinic Proceedings
Publisher: Elsevier BV
Published: 2012-10
Volume: 87
Issue: 10
Pages: 982-990
ISSN: 0025-6196 (ISSN-L)
DOI: 10.1016/j.mayocp.2012.04.017
PMC: PMC3538391
OpenAlex: W2166119767
Cited by: 368
References: 48
Citations by year: 2026: 17 · 2025: 24 · 2024: 62 · 2023: 42 · 2022: 32 · 2021: 35 · 2020: 26 · 2019: 29 · 2018: 25 · 2017: 25 · 2016: 21 · 2015: 11 · 2014: 12 · 2013: 4 · 2012: 3
FWCI: 8.41
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Mayo Clinic Proceedings (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords: off-label drug use, FDA-approved indications, prescribing patterns, physician liability, pharmaceutical marketing, pediatric prescribing, pregnant patients, psychiatric patients, risk-benefit assessment
MeSH terms: Attitude of Health Personnel, Drug Labeling, Female, Humans, Male, Patient Education as Topic, Physician-Patient Relations, Practice Patterns, Physicians', Drug Prescriptions, United States, United States Food and Drug Administration, Safety Management, Off-Label Use

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