Off-label drug uses are defined as taking or prescribing a drug for other conditions than those approved by regulators. For example, doctors frequently prescribe amitriptyline for treatment of migraines, when the actual labeled use is for depression. New studies have found increased adverse effects with increased off-label drug use.
About 12% of doctors prescribe off-label drugs, and many of them do it without even knowing about it. According to a report by the Wall Street Journal, doctors "typically choose a drug based on other patients' experiences with similar conditions or clinical guidelines from professional organizations, which sometimes include off-label use of a drug."
The groups with the highest rate of off-label use include children, pregnant women and psychiatric patients, who are normally excluded from clinical drug trials. In addition cancer patients also have a high rate of off-label prescriptions because one type of anti-cancer drug may be found to be useful for a few cancer types. The most common types of negative side effects of off-label drug uses were gastrointestinal, nervous system and respiratory symptoms.
While off-label drug uses could prove effective for patients, the study's main message is to discourage off-label prescribing or use without strong scientific evidence.