Hyperbaric Oxygen Therapy Ads May Be Misleading, Dangerous: FDA
Federal health officials are warning consumers to be wary of claims that advertise the benefits of hyperbaric oxygen therapy (HBOT) for uses that have not been approved by the FDA.
Numerous internet advertisements have popped up recently claiming HBOT is safe and effective for treating a variety of conditions, including cancer, autism, diabetes and many other diseases.
Many of these uses have not been approved as safe or effective by federal regulators, and the FDA issued a consumer update this week to warn about these misleading ads and to indicate that hyperbaric chambers should not be used for unapproved applications, which may potentially harm consumers.
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Hyperbaric oxygen therapy (HBOT) offers patients increased levels of oxygen in a pressurized chamber. Injured tissue sometimes require more oxygen to heal. The atmospheric pressure in the chamber is raised up to three times higher than normal, allowing the lungs to receive more oxygen.
Treatment also offers an increased amount of oxygen to the blood, which may improve oxygen delivery for vital tissue function. Heightened oxygen may help the body fight infection or minimize injury.
Hyperbaric oxygen treatment can pose risks to users. Some risks are mild others more severe and may include sinus pressure and pain, ear pressure, painful joints, paralysis and air embolism. Hyperbaric chambers also pose a risk of fire, considering the environment is oxygen rich, creating an area which would potentially allow fire to grow uncontrolled.
Hyperbaric chambers are medical devices which require FDA clearance. Clearance is given after the FDA has reviewed validated scientific data which supports the use of the chamber and demonstrates its safety and effectiveness, especially in comparison to other legally marketed devices.
The FDA has approved 13 specific uses of HBOT, including treatment of air or gas embolism or “bubbles in the bloodstream, carbon monoxide poisoning, decompression sickness often suffered by divers and thermal burns.
Unapproved Uses Advertised
HBOT is often advertised as treatment for the use of many other diseases and illnesses, which have not been cleared by the FDA. Some of these uses include treatment for AIDS/HIV, Alzheimer’s disease, asthma, brain injury, depression, diabetes, heart disease, hepatitis, Parkinson’s disease, stroke and many other illnesses.
The FDA warns, HBOT has not been proven as a universal treatment for every illness or injury. These claims often give consumers the impression that they will be helped or cured by the treatment, when often they are endangered by treating their ailment in this manner.
The FDA has received at least 27 complaints from consumers and health care professionals over the past three years about medical centers advertising HBOT as treatment. Often the treatment is ineffective for the advertised purpose and may be dangerous.
“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,” says Nayan Patel, a biomedical engineer in FDA’s Anesthesiology Devices Branch. “In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).”
The FDA warns consumers should discuss the treatment options with a health care provider before treatment. Experts warn patients to consider the benefits and the risks before making a final decision.
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