Off-label drug use refers to the use of a medication in a way that has not been approved by the Food and Drug Administration. This can include using a drug for an unapproved indication, age group, dosage, or route of administration.
Off-label prescribing is legal, but the efficacy and safety of the medication have not been reviewed by the FDA. Off-label use is common and can be beneficial to patients, but it can also increase the risk of harm and liability for providers.
Around 20% of all prescriptions in the United States are for off-label use. Examples of Off-label drug use:
FDA-approved use : treating erectile dysfunction and pulmonary arterial hypertension
Off-label use: treating altitude sickness and Raynaud’s phenomenon
If a patient does not have access to a particular FDA-approved drug, a doctor may prescribe a drug off-label. Drugs in the US are approved and legalized by the FDA. In order to gain FDA approval, drug companies must submit certain information to the agency.
Elaine Silvestrini is an award-winning journalist with 30 years of experience covering state and federal court systems who is with Drugwatch and has given a detailed explanation of Why Doctors Prescribe Drugs Off-Label with fast facts that all healthcare professionals need to be aware of.