Controversies in off‐label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies
Katlein França MD, PhD  Sergio Litewka MD
First published: 31 August 2018 https://doi.org/10.1111/ijd.14222
Funding: None.
Conflicts of interest: None.
Read the full text
ePDFPDFTOOLS SHARE
Abstract
The term “off‐label drug use” involves the prescription of medications for unapproved indications or in unapproved dosage, dosage form, or route of administration. Off‐label medications are common in the management of dermatologic diseases. In the recent years, new indications for botulinum toxin, biologics, spironolactone, topical calcineurin, and topical vitamin D analogues emerged, and these drugs are being used off‐label to treat a variety of conditions. The high cost and long time required for the approval discourage pharmaceutical companies from developing studies and pursuing the approval by regulatory agencies. Patients and physicians may have a different perspective regarding the off‐label use of medications. The ethical discussion is based on the different opinions concerning the need for informed consent by the patient and how this could be applicable in the clinical practice.