Off-label dermatologic therapies. Usage, risks, and mechanisms.
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.
Li
V W
VW
Department of Medicine, Brigham and Women's Hospital, Boston, Mass., USA.
Jaffe
M P
MP
Li
W W
WW
Haynes
H A
HA
D003879:Dermatologic Agents / Q000627:therapeutic use*; D017277:Drug Approval; D004348:Drug Labeling; D006801:Humans; D012307:Risk Factors; D012871:Skin Diseases / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration
D003879:Dermatologic Agents