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FDA seeks to debunk claims about hyperbaric oxygen therapy

The FDA issued a consumer alert to dispel certain claims about hyperbaric oxygen therapy.

“Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies,” Nayan Patel, a biomedical engineer in the FDA’s Anesthesiology Devices Branch, stated in the article. “In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).”

HBOT involves breathing oxygen in a pressurized chamber. The FDA has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness suffered by divers.

Patients may be unaware that the safety and effectiveness of HBOT has not been established for diseases and conditions such as AIDS/HIV, Alzheimer’s disease, asthma, Bell’s palsy, brain injury, cerebral palsy, depression, heart disease, hepatitis, migraine, multiple sclerosis, Parkinson’s disease, spinal cord injury, sports injuries and stroke.

Patel said the FDA has received 27 complaints over the past three years from consumers and healthcare professionals about treatment centers that promoted the hyperbaric chamber for uses not cleared by the agency.

Patients receiving HBOT are at risk of suffering injuries ranging from mild (such as sinus pain, ear pressure and painful joints) to serious (such as paralysis and air embolism). Since hyperbaric chambers are oxygen-rich environments, there also is a risk of fire.

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By | 2013-08-23T00:00:00-04:00 August 23rd, 2013|Categories: National|0 Comments

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