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January 1994

The Use of Food and Drug Administration Approved Medications for Unlabeled (Off-Label) UsesThe Legal and Ethical Implications

Author Affiliations

From the Department of Dermatology and Health Administration, Loma Linda (Calif) University School of Medicine.

Arch Dermatol. 1994;130(1):32-36. doi:10.1001/archderm.1994.01690010036003

Physicians increasingly use Food and Drug Administration (FDA)-approved drugs (medication) for unlabeled (off-label) indications. The ethical and legal implications of these actions are not always clear. In this article, I examine the common law and federal statutory regulations concerning this issue and also explore some of the ethical and financial issues involved.

BACKGROUND  One prescribes a drug in the hope that medication will benefit the person to whom it is given. Yet, every drug has the potential to cause effects on the body that can be beneficial or adverse.1 Adverse reactions can range in seriousness from relatively mild to fatal.1 One estimate showed that adverse drug reactions are responsible for 1.0% to 3.5% of admissions to medical wards.2 One government estimate showed that 130 000 US hospital— based deaths per year were caused by adverse drug reactions.3 These adverse reactions can occur with proper use (idiosyncratic)

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