FDA Concerned About Promotion of Hyperbaric Oxygen Chambers for Unsupported Claims
August 22, 2013
To Whom It May Concern:
Over the last year, the FDA has become increasingly aware of hyperbaric oxygen treatment centers promoting hyperbaric oxygen chambers for uses that have not been cleared or approved by the FDA. Even though the FDA does not regulate the practice of medicine, we are concerned that patients may be choosing hyperbaric oxygen therapy (HBOT) over proven medical treatments without realizing that the FDA has only cleared HBOT devices for 13 specific indications, as outlined at the end of this e-mail. The FDA does not have any data supporting the safe and effective use of HBOT for treatment of any indications not included in this list.
The FDA urges patients to discuss this therapy directly with their health care providers to determine if it is an appropriate treatment option. To provide more information, the FDA has published an FDA Consumer Update: Hyperbaric Oxygen Therapy: Don’t Be Misled. We encourage you to share this article with your members. Additionally, if any of your members suspect they have been injured through use of hyperbaric oxygen chambers, we encourage them to submit a report through MedWatch, FDA’s Safety Information and Adverse Event Reporting program.
If you have any questions about this communication, please contact FDA’s Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, or 800-638-2041, or
FDA-Cleared Indications for HBOT Devices
Air or Gas Embolism
Carbon Monoxide Poisoning, including Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
Gas Gangrene (Clostridial Myonecrosis and Myonecrosis)
Crush Injury, Compartmental Syndrome and Other Acute Traumatic Ischemias
Arterial Insufficiencies (Central Retinal Artery Occlusion, Enhancement of Healing in Selected Problem Wounds)
Necrotizing Soft Tissue Infections
Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
Compromised Grafts and Flaps
Acute Thermal Burn Injury