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FDA Warns that Off-Label Use of Hyperbaric Oxygen Treatment Can Lead to Serious Injury

FDA Warns that Off-Label Use of Hyperbaric Oxygen Treatment Can Lead to Serious Injury

They have become increasingly popular among elite athletes, fitness centers, and luxury day spas, but the Food and Drug Administration (FDA) warns that hyperbaric oxygen chambers are not approved for widespread use. Moreover, the FDA cautions that hyperbaric oxygen treatment, or HBOT, can actually cause injuries in some cases.
Alternative therapies are big business in the United States, generating $34 billion each year, according to a report published by Smithsonian.com. The website, which cites a study conducted by the chief of infectious disease at the Children’s Hospital of Philadelphia, goes on to state that just one-third of alternative treatments undergo any kind of testing to vouch for their safety or effectiveness.

When an individual is placed in a hyperbaric oxygen chamber, he or she is exposed to oxygen levels three times higher than those found in the normal atmosphere. The chamber’s altered air pressure forces more oxygen into a person’s lungs, which may improve the body’s ability to heal injured tissue, fight infection, and reduce injury. Although the FDA has approved HBOT for 13 types of injuries and illnesses, such as flesh-eating bacteria, carbon monoxide poisoning, decompression sickness, and thermal burns, it has not approved HBOT or the use of hyperbaric chambers for any other disease or purpose.

Furthermore, the FDA has issued several warning letters regarding the sale and use of hyperbaric chambers. The agency also issued a warning letter to consumers informing them of potential risks associated with HBOT, which include sinus pain, ear pressure, paralysis, and air embolism – a serious condition that can lead to death. Because hyperbaric chambers operate in an oxygen-rich environment, they are also associated with a significant fire risk. Tragically, there have been several cases in which patients have been killed when hyperbaric chambers exploded.