Beware: Claims of Efficacy of “Off-Label” Uses of Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy (HBOT), which involves exposure of the body in a chamber to 100% oxygen under pressure, is widely know as a treatment for “the bends,” the common name for decompression illness in divers. The FDA long ago approved this use of HBOT. The benefit obtained from HBOT for that and other approved uses derives from injured tissue being exposed to up to three times greater oxygen than is dissolved in the blood through breathing ordinary oxygen at normal air pressure.
Hyperbaric chambers are FDA regulated medical devices requiring FDA clearance, which obtained only after FDA has reviewed valid scientific evidence supporting the use, and its safety and efficacy. In addition to decompression sickness, 12 other uses of HBOT have been cleared by FDA, including air or gas embolism, carbon monoxide poisoning, enhancement of healing in certain problem wounds such as diabetic foot ulcers, and burns caused by heat or fire.
Recently however, an increasing number of consumer complaints coupled with an increase in Internet advertising of claims by HBOT treatment centers of efficacy for a host of other diseases and conditions including AIDS/HIV, cancer, traumatic brain injury, sports injuries generally, and autism in children, led FDA to issue a consumer update advising consumers not to be misled by these claims. In the update, FDA advises of its concern that some efficacy claims made by HBOT treatment centers could give consumers a “wrong impression that could endanger their health.” Click here to read the full update.
One area of most heated debate between HBOT experts, regulators, and patient advocates is the use of this therapy for treatment of autism in children. Although some parents of autistic children have reported improvements, and have gone so far as to spend tens of thousands of dollars to purchase hyperbaric chambers, no clinical evidence in peer-reviewed medical literature exists to support this “off label” use HBOT. Notably, not long ago a northern New Jersey medical center withdrew a request it had submitted to the State’s Department of Health and Senior Services to use this experimental method to treat autistic children. But, after public reports emerged regarding the controversy surrounding the treatment for autistic children, the medical center announced that it would instead continue to focus on more conventional widely-accepted uses for the therapy such as diabetic wound care.
The cautionary consumer update regarding HBOT provides a reminder of the FDA’s reach in regulating medical devices and of the need for manufacturers and health care providers to be circumspect before pressing “off-label” uses of devices before sufficient scientific substantiation exists to support them.
For more information, click here.