Patients who are given prescriptions for drugs often don’t know that the medicines haven’t been approved by the Food and Drug Administration for a particular purpose. The practice, known as “off-label drug use,” is common.
Off-label drug use is legal, but it isn’t regulated, according to the American Cancer Society (ACS). The exception: certain controlled substances, including painkillers.
In a study published in the “Mayo Clinic Proceedings,” researchers reported that in a group of five commonly used medications, one in five prescriptions was for an off-label purpose.
Off-label use, according to the ACS, usually occurs with older, generic medicines for which a new use has been found. The process required to obtain official FDA approval is long and expensive, and may require more money and research than pharmaceutical companies are willing to spend on generic drugs. Another variation on off-label drug use is prescribing a dosage not originally approved by the FDA.
Drugs that are commonly prescribed for off-label use include antidepressants originally designed to treat neuropathy. Inhaled broncodilators are also commonly prescribed for off-label use by children.
There are no laws that require doctors to disclose off-label use to a patient, Mayo reported, and physicians aren’t liable for any effects of off-label use.
The Mayo researchers called for patients to become aware of how common off-label use is. Lead author Dr. Christopher Wittich, an internal medicine physician at the Mayo Clinic in Rochester, Minn., said in a statement, "Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one."
