Prescribing “off-label”: What should a physician disclose?

Abstract

This case highlights clinical dilemmas faced by physicians when treating patients with conditions for which there are limited or no FDA-approved treatment options. First, it raises questions about when it is appropriate to prescribe medications for “off-label” indications and what might be the ethical and legal implications of doing so. It also prompts us to consider why pharmaceutical companies might or might not pursue FDA approval for new indications when a drug has already been approved for use in another condition. Finally, this case demonstrates the importance of employing shared decision making when discussing complex clinical decisions and how such techniques might have led to different outcomes and better understanding between Dr. Shannin, Maxine, and Heather.