Question: Many uses for HBOT are termed "off-label" by the FDA. What does that mean?
Answer: Any medication or medical device that is prescribed for a particular diagnosis that does not appear on the FDA's approved, or "labeled", list is considered "off-label". Off-label uses are neither risky nor investigatory; they constitute the traditional practice of medicine that has existed long before the FDA. In the article, "FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions", Dr Beck and Dr Azari discuss many instances where patients are frequently prescribed medications for "off-label" conditions.
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