In a July 26 release entitled “Hyperbaric Oxygen Therapy: Get the Facts” the U.S. Food and Drug Administration (FDA) has cleared the use of hyperbaric oxygen therapy (HBOT/HBO2) for the treatment of several conditions. The release further states: “If your health care provider recommends HBOT, the FDA advises you get the treatment at a hospital or facility that has been inspected and is accredited by the Undersea and Hyperbaric Medical Society.”
The agency advises that individuals seeking hyperbaric oxygen therapy check with their health care provider to make sure they are pursuing the most appropriate care, noting that some facilities operate outside recognized FDA guidelines. “The FDA is aware there are some hyperbaric oxygen treatment centers promoting hyperbaric oxygen chambers for uses that have not been cleared or approved by the FDA, such as treatment of cancer, Lyme disease, autism, or Alzheimer’s disease.”
FDA-cleared conditions to be treated with hyperbaric oxygen
The FDA has cleared hyperbaric oxygen therapy for treatment in these disorders:
• air and gas bubbles in blood vessels
• anemia (severe anemia when blood transfusions cannot be used)
• burns (severe and large burns treated at a specialized burn center)
• carbon monoxide poisoning
• crush injury
• decompression sickness (diving risk)
• gas gangrene
• hearing loss (complete hearing loss that occurs suddenly and without any known cause)
• infection of the skin and bone (severe)
• radiation injury
• skin graft flap at risk of tissue death
• vision loss (when sudden and painless in one eye due to blockage of blood flow)
• wounds (non-healing, diabetic foot ulcers)
HBO2 treatment is being studied for other conditions, including COVID-19, but has not cleared or authorized the use of any hyperbaric device to treat COVID-19 or any conditions beyond those listed above. The websites clinicaltrials.gov and the UHMS home pages at https://www.uhms.org/images/Position-Statements/HBO2_and_COVID_8-10-2020_clinicaltrials_8-12-2020.pdf have more information on hyperbaric clinical trials for COVID-19 and other conditions.
~ Taken from MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Get more information on hyperbaric oxygen treatment
About the UHMS
Formed in 1967 the UHMS is an important source of scientific and medical information pertaining to undersea and hyperbaric medicine through its bimonthly, peer-reviewed journal, Undersea and Hyperbaric Medicine, symposia, courses, certifications, workshops and publications.
UHMS organizes an annual scientific meeting at different U.S. and international locations to permit review of the latest in research and treatment and to promote the highest standards of practice.
For more information on the UHMS see www.uhms.org