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What does "off-label use" mean? I see this sometimes in tiny print at the end of articles in health magazines.

"Off-label" refers to the use of drugs and medical devices for some other purpose than what they were meant to be used for. For example, a drug for seizures (Neurontin) has been found to work for patients with diabetes who have nerve pain from peripheral neuropathies. Another off label use is a drug for asthma (Terbutaline). This drug is used to prevent premature labor in pregnant women. Or there’s the spine surgeon who uses substitute bone graft in ways that haven't been tested yet.

The Food and Drug Administration (FDA) requires doctors to use legal drugs and devices as they were meant to be used. Doctors are free to prescribe as they wish but the FDA says drug-makers can’t advertise treatments that aren’t tested or approved.

Off label use must be done with careful record keeping. It's considered "investigational" until studied and proven effective. It can have dangerous side effects including death.


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