off-label use of a drug

What “off-label” use of a drug really is, and why you need to know about it

Gregory Curfman, MD

Assistant Professor of Medicine, Former Editor-in-Chief, Harvard Health Publishing

You might be surprised to learn that, on average, one in five prescriptions are written for an “off-label” use of a drug. That means the doctor believes that the recommended drug will help a patient, even though that drug has not been FDA-approved for that patient’s particular condition or symptoms. This practice is legal and common. Historically, the FDA has restricted the ability of pharmaceutical companies to advertise drugs for off-label uses. However, two recent court cases have opened the door to proactive promotion of drugs for off-label uses. Physicians and consumers need to be aware of this shift when it comes to using drugs safely for off-label purposes.