Off-label drug use occurs when physicians prescribe a drug for indications other than those listed on the product label or package insert. Although off-label uses are usually based on clinical studies, these potentially useful therapies have not been approved by the Food and Drug Administration (FDA). Clinicians opposed to off-label drug use express concern that the potential risks may be the same or even greater relative to the benefits.

Pregnancy poses a unique situation with regard to off-label drug use. Conceptually, treatment of the mother and fetus can be approached independently; however, from a practical viewpoint, neither can be treated alone, which can represent a conflict of interest. A drug prescribed in an off-label manner should not “just be tried out” but used to answer the question “does it really work?”