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Off Label

There are many other chronic conditions not yet officially approved by the FDA.  These conditions are termed “off-labels.” When a drug or device is approved for marketing by the FDA, it normally has to state a list of indicated use. The list would include what diagnoses the particular drug or device would be used to treat.  When the drug or device is used for a particular diagnosis that does not appear on the original list, then for that indication it is considered "off-label". (Device Labeling Guidance, FDA Guidance Doc. No. G-91, pt. III May 8, 1991)

Off-label uses are neither risky nor investigational; they constitute the traditional practice of medicine that has existed long before the FDA. The off-label designation by the FDA is simply a term they use to mean they are silent on the indicated use. Medicare, medicaid, and private health insurances cover medically approved uses of HBOT only. As such, there are many other conditions that are considered “off-label” which are not covered by insurance companies.

Listed below, are some promising use of mild Hyperbaric Oxygen Therapy (mHBOT):

  • Lyme disease
  • Acute Coronary Syndrome (ACS)
  • Alzheimer’s
  • Autism
  • Cerebral Palsy (CP)
  • Migraine/Headaches
  • Multiple Sclerosis (MS)
  • Stroke
  • Traumatic Brain Injury (TBI)
  • Vascular Dementia (VD)
  • Arthritis
  • Chronic Fatigue Syndrome (CFS)
  • Complex Regional Pain Syndrome (CRPS)
  • Fibromyalgia
  • Chemotherapy Recovery
  • Cancer