Off-label

Off-label use refers to the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs can be used in off-label ways, although most studies focus on the use of prescription drugs.

Overview

Off-label use is generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used by healthcare providers worldwide to provide care to patients. Off-label use is also often done in pediatric populations and in areas of medicine where patients may not be able to undergo more traditional treatments.

Regulation

In the United States, the Food and Drug Administration (FDA) has a process for drug companies to get official approval for new indications, but this is not required. The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Conversely, in some countries it may be illegal to use certain drugs off-label.

Risks and benefits

While off-label use often relies on high quality evidence, this is not always the case. Without rigorous testing of drugs, side effects and long-term effects may not be fully understood. Such use may be done out of desperation in patients who have failed other treatments. However, there can also be significant benefits to off-label use. For example, many drugs are commonly prescribed off-label in oncology.

See also

• Prescription drug
• Food and Drug Administration
• Ethics in pharmaceutical sales
• Pharmaceutical marketing

References

Off-label Resources
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