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ON-LABEL/ OFF-LABEL AND YOUR HEALTH CHOICES

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DR. JOSEPH DITURI (Dr. Deep Sea)

FEB 2025

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I'd like to talk to you a little bit about on-label and off-label. But first I have a question for you. What is Viagra used for?


All kidding aside, that's right--it's FDA-approved as a cardiac drug. Wait...what? That's right, its off-label use is for erectile dysfunction. However, it is prescribed significantly more in its off-label capacity than it is for its FDA-approved capacity.

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The same is true for Hyperbaric medicine. Hyperbaric medicine has 16 approved indications. That means that the FDA has signed off that these work, and most insurances may pay for those conditions. However, there are quite literally hundreds of possible off-label indications for which hyperbaric oxygen therapy can be prescribed. The most important thing to do is for the provider to understand the mechanism of action. Any drug is prescribed because of its mechanism of action. In the case of hyperbaric oxygen therapy, there are 13 known mechanisms of action.

  1. Decrease bubble size.

  2. Hyperoxygenation.

  3. Reduced lipid peroxidation.

  4. Vasoconstriction.

  5. Reduced intervascular leukocyte adherence.

  6. Toxin inhibition.

  7. Leukocyte oxidative killing.

  8. Antibiotic Synergy.

  9. Growth factor release such as angiogenesis, neurogenesis, or mitogenesis.

  10. Fiberglass proliferation secondary to collagen synthesis.

  11. Stem cell proliferation.

  12. Increase reverse transcriptase activity.

  13. Reduction of cytokine activity which, in turn, reduces inflammation.

Dr. Joseph Dituri

Dr. Dituri is a biomedical engineer, retired Navy commander, and hyperbaric medicine expert.

Any provider worth their salt knows the mechanisms of action of any drug they prescribe. A course by the International Board of Undersea Medicine can help you understand them and apply them across a broad spectrum of maladies scientifically with the backing of peer-reviewed publications. That's the best way to affect care for the patient.


Hyperbaric oxygen therapy is a safe and effective primary care or adjunctive care protocol that is FDA-approved. Regardless of how the provider chooses to use this drug, they should be looking at the science behind it and whether or not there's efficacy so that they can do no harm to the patient and they can affect change.

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Don't let any of these self-proclaimed experts in Hyperbaric medicine tell you that it is illegal or that you are not allowed to get Hyperbaric medicine off label. The fact is that it is not a problem whatsoever to be treating somebody off label, and no person should shame you for seeking alternative natural help for whatever problem you may have. The ONE solid piece of advice is that you should KNOW the mechanism of action of the drug oxygen and see if the science fits the possible help you need. 


Everything should be done scientifically and at a reputable chamber facility. For instance, if you don't see an emergency procedures binder at the clinic you are previewing...you should not be there. Additionally, ensure they are taking great care of their patients and operating within sound scientific principles. A little bit of homework on your end before going to see the chamber will help.

The Art and Science of Hyperbaric Medicine

The book will demystify hyperbaric therapy and provide comprehensive information about its applications.

There is no one-size-fits-all treatment. For instance, a review of the literature appears to indicate that if you are looking for the mechanism of action to inhibit toxins, we know that if you get above 250 mmhg at the cellular level that toxins are not produced. This will absolutely help understand which pressure at which the patient should be treated. A quick bit of mathematics suggests that you should be above 2.4 when trying to inhibit toxins.


This is a very complex sort of treatment protocol to wrap your arms around and just do a one-size-fits-all. I would shy away from those clinics that are cookie cutter and do not offer different treatment protocols for different ailments. You can get some good healing from Hyperbaric medicine, but it has to be administered correctly in order to facilitate your best healing. 


You can find more information from "The Art and Science of Hyperbaric Medicine," a book now available online. This book can help you understand the pitfalls and issues with hyperbaric medicine and let you know what the possibilities are, scientifically speaking, from being treated with hyperbaric medicine. 


Remember, your health is the most important thing, so please be careful about what center you choose to use for your health.

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