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November 1998

Off-Label Dermatologic Therapies: Usage, Risks, and Mechanisms

Author Affiliations

From the Division of Dermatology, Department of Medicine, Brigham and Women's Hospital, and the Department of Dermatology, Harvard Medical School, (Drs V. W. Li and Haynes) Boston, Mass; and the Angiogenesis Foundation Inc, Cambridge, Mass (Drs V. W. Li, and W. W. Li and Mr Jaffe). Information presented herein is intended for educational purposes and does not constitute medical or legal advice.

Arch Dermatol. 1998;134(11):1449-1454. doi:10.1001/archderm.134.11.1449

Off-label refers to the prescribing of Food and Drug Administration–approved drugs for a use not indicated on the package insert. The prescribing of off-label drugs may benefit patients with many dermatologic diseases including angiogenesis-related conditions. We surveyed 55 dermatologists from a single large academic program to assess their use of particular drugs for specific skin conditions, their perception of such use as being for Food and Drug Administration–approved or for off-label indications, and their attitudes towards off-label therapies. The practice of prescribing off-label drugs was common among the respondents, many of whom had misperceptions about which conditions are Food and Drug Administration–approved indications and about the legal ramifications of off-label therapies. We suggest that understanding the principles of off-label prescribing in conjunction with the mechanisms of drug action in diseases may help clinicians exercise their judgment in finding innovative therapies for their patients.

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