HBOT Treatments and Conditions Treated
If you are considering Hyperbaric Oxygen Therapy (HBOT) treatments, there is a good chance you have come across the terms “FDA Approved” and “Off-Label” when discussing conditions. For many people, this is confusing and concerning when it comes to their medical care. While many conditions are currently FDA approved for HBOT, many are still not. This does not, however, mean that HBOT is not an acceptable treatment option for those other conditions as well. To start, let’s look at what “FDA Approved” really means and how it affects your healthcare options.
The Department of Health and Human Services’ Food and Drug Administration, or FDA, is the agency responsible for protecting the public health and regulating pharmaceutical drugs, biologics, medical devices, tobacco products, food, cosmetics and more. For a drug, medical procedure, or device to receive FDA approval, the manufacturer must prove that they are safe and effective. The FDA makes its decision by reviewing laboratory results, test results, and clinical studies. If a drug or device receives approval, this means the FDA determined that the benefits of the product or treatment outweighed the possible risks.
- Air or Gas Embolism
- Carbon Monoxide Poisoning
- Clostridial Myositis and Myonecrosis (Gas Gangrene)
- Crush Injuries, Compartment Syndrome and Other Acute Traumatic Ischemia
- Decompression Sickness
- Arterial Insufficiencies, such as Central Retinal Artery Occlusion
- Severe Anemia
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory)
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- Compromised Grafts and Flaps
- Acute Thermal Burn Injury
- Idiopathic Sudden Sensorineural Hearing Loss
The term “FDA Approved” is something you may be familiar with. In contrast, a drug or treatment receives the term “Off-Label” when doctors use it to treat a condition that is not FDA approved. HBOT treatment, or hyperbaric oxygen, is only approved for 14 different medical conditions to date. However, physicians and researchers see positive results in many more conditions. Therefore, HBOT treats off-label conditions on a daily basis. This practice is not new to medicine. It would amaze you at how many conditions find relief through off-label use every day.
The use of off-label medications and treatments is nothing new to everyday medicine. It is also not something that is HBOT specific. By FDA rules, physicians have the ability to treat their patients with medications off-label and as a result, often find surprising results. When doctors use a medication off-label and find positive results, they trigger the beginning of medical research and clinical trials necessary to receive a new FDA approval. In the case of HBOT, physicians use and find success in treating many off-label conditions. These conditions include RSD, Alzheimer’s disease, Lyme disease, traumatic brain injuries, PTSD, Fibromyalgia and many, many more.
Call our office today for more information or to schedule an initial consultation with Dr. Spiegel and his team. You can also visit HERE and fill out a contact form and someone will be in contact with you. Take the next step in your healing process and see how HBOT can benefit you!!