- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA: Hyperbaric Oxygen Therapy Is No Cure-All
Internet sites tout unapproved uses (August 22)
Hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or to be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by the FDA.
HBOT involves breathing oxygen in a pressurized chamber. The FDA has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness experienced by divers.
HBOT has not, however, been proven to be the kind of universal treatment it has been touted to be on some Internet sites. For example, the safety and effectiveness of HBOT have not been established for the treatment of HIV/AIDS, Alzheimer’s disease, asthma, brain injury, cerebral palsy, depression, heart disease, hepatitis, migraine, multiple sclerosis, Parkinson’s disease, spinal cord injury, sports injury, or stroke.
The FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.
“Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by the FDA, which may cause them to delay or forgo proven medical therapies,” says Dr. Nayan Patel, a biomedical engineer in the FDA’s Anesthesiology Devices Branch. “In doing so, they may experience a lack of improvement and/or worsening of their existing conditions.”
Patel says the FDA has received 27 complaints from consumers and health care professionals over the past 3 years about treatment centers promoting the hyperbaric chamber for uses not cleared by the agency.
Source: FDA; August 22, 2013.