What is an unlabeled use of medication?

An unlabeled use of medication refers to a use that has not been approved by the FDA. This means that while a medication might be indicated for certain conditions or symptoms as outlined in its labeling or package insert, healthcare providers may prescribe it for other conditions based on their clinical judgment and existing evidence. These off-label uses occur quite frequently in practice, especially for treatments that may not yet have received formal approval for specific conditions due to various factors, including the need for further research or evolving medical understanding. Understanding unlabeled uses is crucial for healthcare professionals, as this often encompasses significant areas of therapy, particularly in complex cases where standard treatments may not be effective.