FDA Warns that Oxygen Not Always a Life Saver

Hyperbaric oxygen therapy does not work for certain conditions and can have serious risks

(RxWiki News) Normal body tissue needs oxygen to function. And when tissues are injured, they need extra oxygen to heal. A type of therapy that provides this extra oxygen has become popular in recent years.

The Food and Drug Administration (FDA) recently issued a consumer update about the use of this therapy — called hyperbaric oxygen therapy — for unapproved conditions.

Hyperbaric oxygen therapy has not been clinically proven to cure or be effective in treating cancer, autism, diabetes and a host of other conditions, said the update. In some cases, this type of therapy may even endanger health, the FDA warned.

"Ask your doctor about the risks and benefits of your treatments."

The consumer update was issued by the US Food and Drug Administration (FDA).

The aim of this update was to warn people about unapproved use of hyperbaric oxygen therapy and its potential adverse effects.

Hyperbaric oxygen therapy uses a special chamber to increase the amount of oxygen the patient breathes in, which then increases the concentration of oxygen in the blood. An increase in blood oxygen may help deliver more oxygen to important tissues and help combat infections, minimize injury and promote wound healing.

Some hospitals in the US are equipped with a hyperbaric oxygen chamber. Smaller units may be available in outpatient clinics.

The FDA classifies hyperbaric chambers as medical devices that need to be cleared as safe and effective before they can be sold on the market.

In the past three years, the FDA has received 27 complaints from health professionals regarding the unapproved use of hyperbaric oxygen chambers.

According to the FDA consumer update, hyperbaric oxygen has only been approved to treat 13 conditions. Key examples of these conditions include air or gas embolism, which is basically a dangerous "bubble" in the blood that can block blood vessels, carbon monoxide poisoning and burns caused by heat or fire.

Despite claims made by certain websites and medical practitioners, the consumer update points out that there is no direct evidence that hyperbaric oxygen therapy cures or is an effective treatment for a host of other conditions.

These include HIV/AIDS, Alzheimer's disease, asthma, Bell's palsy, brain injuries, cerebral palsy, depression, heart disease, hepatitis, migraines, multiple sclerosis, Parkinson's disease, spinal cord injuries, sports injuries and stroke.

In fact, sometimes, hyperbaric oxygen therapy might even put people’s health at risk.

Patients receiving this type of therapy are at risk of suffering mild injury such as sinus pain, ear pressure and painful joints. But the adverse effects can also be serious, says the FDA, and may include paralysis or air embolism. Since hyperbaric chambers are also loaded with oxygen, there is also a risk of fire.

"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," said 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," warns Patel.

"If you're considering using [hyperbaric oxygen therapy], it's essential that you first discuss all possible options with your healthcare professional. Whatever treatment you're getting, you need to understand its benefits and risks. Your health care professional can help you determine which treatment is your best option,” Patel advised.

The consumer update was published by the FDA on August 22.

Review Date: 
August 26, 2013