Off-label dermatologic therapies. Usage, risks, and mechanisms

Arch Dermatol. 1998 Nov;134(11):1449-54. doi: 10.1001/archderm.134.11.1449.

Abstract

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.

MeSH terms

  • Dermatologic Agents / therapeutic use*
  • Drug Approval*
  • Drug Labeling*
  • Humans
  • Risk Factors
  • Skin Diseases / drug therapy*
  • Surveys and Questionnaires
  • United States
  • United States Food and Drug Administration

Substances

  • Dermatologic Agents