Off label

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

Definition

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 treat a wide range of conditions.

Prevalence

Off-label use is very common. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31%. In oncology, off-label use of drugs is quite common because the field moves quickly and it's common for drugs to be used off-label before the official approval catches up.

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. It's also not required for a doctor to prescribe a drug off-label.

Risks

While off-label use often is beneficial or even standard medical practice, it can also be risky. The biggest risk is that there may not be enough evidence that the off-label use is effective or safe.

See also

• Prescription drug
• Over-the-counter drug
• Food and Drug Administration
• Oncology

Off label Resources
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