‘Off-Label’ refers to the use of certain drugs or medical procedures that were not yet approved by the FDA or Health Canada for official marketing purposes. There is only a chance for approval for these after passing rigorous studies, demonstrating quantifiable proof to treat specified illnesses. The use or limitations of these are subject to the approval of the FDA or Health Canada. The research needed to support the viability of a drug or medical procedure can be very costly. Since oxygen is readily available and patenting it is impossible, the small profit made from the sale of this good is not sufficient to fund studies with regard to the use of hyperbaric oxygen therapy that would meet the requirements of these two popular regulatory bodies.

In 2003, however, the attempts of the International Hyperbaric Medical Association to work with the FDA and other government regulatory bodies paid off when hyperbaric oxygen therapy was approved for the treatment of diabetic foot wounds. Although many types of illnesses are not approved by the FDA to be treated with HBOT, the Ethics Task Force of the Undersea and Hyperbaric Medical Society in 1998 found that HBOT passes ethical practices supported by the Hippocratic Oath which states that “…I will apply dietetic measures for the benefit of the such according to my ability and judgement; I will keep them from harm and injustice”, translated in modern age as, “I will apply, for the benefit of the sick, all measures which are required.”

Today, the off-label use of HBOT is now being used to treat a wide variety of illnesses. In fact, the International Hyperbaric Medical Association promotes its off-label use. HBOT is considered generally safe and should be prescribed by a physician. This procedure is commonly performed under the supervision of a medical practitioner. Just like other medical procedures, there are some risks associated with its use hence one should get a medical advice prior treatment.

Listed below are some of the conditions that have the ‘off-label” mark for HBOT: 

  •     ADD / ADHD
  •     Asthma / Allergies
  •     Altitude Sickness
  •     Alzheimer’s / Dementia
  •     Autism Spectrum Disorders
  •     Brain Injury
  •     Burns
  •     Cerebral Palsy
  •     Chronic Fatigue Syndrome
  •     Circulation Issues
  •     Diabetic Complications
  •     Digestive Disorders
  •     Disc Herniation
  •     Dizziness
  •     Fibromyalgia
  •     Flu
  •     Frequent Flying / “Jet Lag”
  •     Headaches / Migraines
  •     Hypoxia
  •     Immune Deficiency Infection – (Bacterial, Fungal, Viral)
  •     Inflammation
  •     Lyme Disease
  •     Multiple Chemical Sensitivity
  •     Multiple Sclerosis
  •     Muscle / Tendon / Joint Pain
  •     Premature Aging
  •     Rheumatoid Arthritis
  •     Sleep Disorders
  •     Smoking
  •     Sports Enhancement & Injury Recovery
  •     Stress / Anxiety / Depression
  •     Stroke
  •     Surgical Recovery
  •     Toxic Environmental Exposure
  •     Wound Healing

Disclaimer: Information found in this page should only be used for educational purposes only. MC Rehabilitation and Wellness recommends that you talk to your physician for proper medical recommendation including for therapies like HBOT.


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