Breaking Stigmas: Off-Label Medical Treatments Proven Effective in Treating Mental Health Challenges
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Off Label & FDA
In the mental health world, stigmas often arise from a need to understand the challenges faced by those experiencing mental health issues. This uncertainty causes hesitation or avoidance to seek treatment that can effectively help and furthers individuals into the stereotypes of mental health challenges and emotional trauma like anxiety, depression, and post-traumatic stress.
The same can be said of off-label medical treatments. Stigmas can often deter individuals from seeking the care they need. Usually, there is a common misconception that off-label treatments are unsafe or ineffective. However, this is simply not the case.
Off-label use of medications and treatments has been a common practice in medicine for many years, and many treatments used off-label have been proven effective in treating various conditions. An estimated 30% of all medications are prescribed off-label, including many cancer drugs, and are frequently used by physicians even though they are not FDA-approved for that particular purpose.
For example, aspirin is often prescribed off-label to reduce cardiac risk factors, while Wellbutrin is commonly used off-label to treat ADHD.
The designation of "off-label" use for a medication does not necessarily indicate that the FDA has conducted drug trials and determined the substance to be unsafe or ineffective. Rather, it may simply imply that the FDA has not yet completed clinical trials for the specific use in question.
Let's explore these effective treatment protocols that are considered "off-label":
The Stellate Ganglion Block (SGB) and off-label use
The dual sympathetic reset (DSR), an advanced stellate ganglion block (SGB), which the FDA has approved for pain management, is a treatment that involves injecting a local anesthetic into the stellate ganglion nerve located on both sides of the neck. For years, it has been used to treat pain and hot flashes due to menopause. Now, SGB can also be safely and effectively used off-label by licensed professionals to treat emotional trauma and mental health challenges like anxiety, depression, and post-traumatic stress and their symptoms like trouble sleeping, fatigue, worry, and difficulty concentrating.
The anesthetic used in SGB is either Ropivacaine or Bupivacaine, both of which are local anesthetics. The FDA approved both Bupivacaine and Ropivacaine for use as a local anesthetic. Bupivacaine is commonly used in many medical procedures, such as epidurals during childbirth. Ropivacaine is used to cause numbness or loss of feeling before and during surgery, labor, and delivery and relieves acute pain.
Over the last decade, the stellate ganglion block (SGB) treatment has adapted in ways that show great promise and higher success rates in relieving symptoms of emotional trauma and mental health challenges with Stella's Dual Sympathetic Reset.
The Dual Sympathetic Reset Protocol
The dual sympathetic reset is an advanced stellate ganglion block (SGB) protocol developed by Dr. Eugene Lipov, Stella's Chief Medical Officer. It involves administering two local anesthetic injections of Bupivacaine or Ropivacaine, used off-label, near a cluster of sympathetic nerves in one side of the neck responsible for triggering the fight or flight response.
The injection of anesthetic can reduce the levels of norepinephrine and eliminates excess nerves through a process known as pruning.
These combined effects can help restore normal biological function and relieve even the most severe symptoms of emotional trauma and mental health challenges.
Ketamine Infusion and off-label use
Ketamine, which has been FDA-approved as an anesthetic medication, has also been shown to be effective off-label in treating symptoms of depression and anxiety –– though the nasal spray form of ketamine, Esketamine, has recently been explicitly FDA-approved for treating suicidal ideation.
Stella uses the safest approach working with ketamine during ketamine infusion - Providing ketamine in a dose-controlled manner through a series of infusions.
Ketamine selectively interacts with essential neurotransmitters in the brain. Increasing glutamate levels between neurons activate the AMPA receptor, leading to synaptogenesis. This process controls communication between neurons and can affect mood, thought patterns, and cognition.
Over the years of its use off-label, it has been found to improve mood and reduce symptoms of depression by increasing glutamate levels in the brain with minimal side effects.
Effects of off-label use
There are minimal side effects to treatment with DSR and ketamine infusion, and there is no evidence that either is habit-forming or addictive when administered in a medically supervised course of treatment.
At Stella, our medical professionals carefully consider and monitor off-label use to ensure the safety and efficacy of the treatment.
Every day, the mental health and medical community at large is discovering that off-label use is vital. It allows healthcare providers to explore alternative treatments for various medical challenges beyond what the drug was initially approved for. This can be particularly beneficial when conventional treatments are ineffective or limited treatment options are available.
Stigmas surrounding off-label medical treatments should not deter individuals from seeking out the care they need. Stella's innovative treatments have shown promise in treating debilitating symptoms for those seeking relief.
Treatment by Stella has the potential to help millions of people with emotional trauma experience lasting relief. To learn more, please visit our Care Approach page. If you want to learn more about Treatment by Stella or schedule an assessment with our trauma-informed Advanced Practice Providers, call our Care Advocate Team now: (908) 293-7559