Facts On Off-Label Drug Use

The term ‘Off-label’ refers to the use of drugs to treat diseases or medical conditions for which they are unintended. While off-label use may seem appealing for ailments with no known solution, it can potentially harm these users.

According the FDA, drugs only receive approval after extensive scientific research. Before approval, a company must submit clinical information to the FDA for review. When the FDA approves a drug, it conducts a careful evaluation of the benefits and risks and uses strong scientific data to support the decision. The drug must prove its benefits outweigh potential risks before being deemed “safe.” The FDA also approves the label, which provides key information about what the drug treats, how to use it, information about risks and more.

Off-label use may occur for various reasons. For instance, a medical professional may believe a drug can treat a certain disease or medical condition that currently does not have an approved treatment. Off-label use may also occur if a patient tried the approved treatments for their disease or medical condition but did not see any benefits or results.

The FDA relies on scientific data for drug approval, and as such, cannot approve certain drugs for certain diseases and medical conditions. For example, a drug may be approved to treat nausea and vomiting following chemotherapy and surgery, but might be used off-label to treat morning sickness. No scientific data proves the drug’s effectiveness for treating morning sickness and as a result the FDA cannot approve the drug to treat this ailment. Off-label use can result in unforeseen consequences and side effects thus leading to additional illnesses and medical complications. Similar to this, those considering off-label use should talk to their doctor in depth about the drug and voice any concerns.