HBOT is "approved" in the United States for 14 "accepted" indications (5) which essentially means indications approved by the HBOT Committee of the Undersea and Hyperbaric Medical Society, and secondarily, the FDA. Internationally, however, hyperbaric oxygen therapy has a much larger list of applications, some of which are documented by stronger scientific evidence than exists for the accepted indications (18, 19). The indications not on the "accepted" list are considered off-label uses of hyperbaric oxygen therapy by the FDA. The off-label use of any FDA-approved medical device or drug is allowed by the FDA for a licensed physician and has generated the data that forms the basis for much of the clinical medical research in the United States. One of the best recent examples of this phenomenon is the drug bupropion, trade names Wellbutrin and Zyban. Wellbutrin had initial FDA approval only as an antidepressant until a psychiatrist noticed that her depressed patients treated with this drug spontaneously quit smoking. Initial reports of this phenomenon spurred doctors throughout the U.S. to begin prescribing the drug for smoking cessation in an off-label fashion. These reports, plus the burgeoning off-label use, spawned three large-scale clinical trials that duplicated the findings of the LA psychiatrist and led to FDA approval for smoking cessation.
Every dosing of Wellbutrin in the United States for smoking cessation from the psychiatrist's initial prescriptions to the FDA-approval for this indication as Zyban was an off-label use of Wellbutrin. Other current examples of off-label uses of drugs include Neurontin, antidepressants, and EDTA. Neurontin is FDA-approved only for seizures, yet the vast majority of its prescribing is for traumatic brain injury, stroke, peripheral neuropathy, and a host of other neurological disorders, all of which are off-label. Antidepressants are FDA-approved only for depression; however, they form the mainstay of chronic therapy for migraine headaches, chronic pain syndromes, and various forms of organic brain injury, again, all of which are off-label uses. Lastly, EDTA is a chelating agent, FDA-approved exclusively (yet, rarely used) for the treatment of lead poisoning, which has become a widespread off-label drug for atherosclerotic vascular disease or "hardening of the arteries." Off-label uses of FDA-approved drugs are commonly known as the clinical practice of medicine and occur everyday in nearly every doctor's office and hospital across the United States with these and a plethora of other FDA-approved drugs. HBOT for anything except the 14 "accepted" indications is similarly an off-label use of HBOT.
19. Mitton C, Hailey D. Health technology assessment and policy decisions on hyperbaric oxygen treatment. Int J of Tech Assess in Health Care, 1999;15(4):661-70