FDA warns against psychedelic use.
The FDA Warns About the Risks of Compounded Ketamine
The Food and Drug Administration (FDA) issued a warning on Tuesday regarding the dangers associated with compounded ketamine, a type of psychedelic drug.
In recent years, there has been a surge of interest in using ketamine to treat psychiatric illnesses. Unfortunately, illicit use of ketamine is also on the rise.
Despite this growing interest, the FDA emphasizes that there is no evidence to suggest that compounded ketamine is safer, more effective, or faster-acting than FDA-approved medications for psychiatric disorders.
Ketamine is not approved by the FDA for the treatment of any psychiatric disorder. Despite this, compounded ketamine products have been marketed for various psychiatric conditions. However, the FDA has not determined the safety and effectiveness of ketamine for these uses.
What Is Ketamine?
Ketamine is a schedule 3 controlled substance that the FDA has approved for anesthesia induction and maintenance through injection.
Ketamine, a generic anesthetic, has hallucinogenic effects that distort sight and sound perception and create a sense of disconnection from pain and surroundings.
While ketamine is considered a psychedelic due to its impact on perception and environment, it works differently from traditional psychedelics.
Most psychedelics stimulate the brain’s “movers and shakers” responsible for thinking and voluntary movement. In contrast, ketamine inhibits the cells that control these pyramidal cells, resulting in slightly weaker effects.
The FDA has not established a safe or effective dose of ketamine for psychiatric use. However, some healthcare providers prescribe it off-label for certain conditions.
Spravato, a nasal spray containing only S-ketamine molecules, is FDA-approved for treatment-resistant depression and suicidal ideation in adults with major depressive disorder.
Unlike Spravato, compounded ketamine products are not monitored under the FDA’s drug safety program. Therefore, the FDA warns that these products may be less safe.
Health Risks of Ketamine
In its warning, the FDA highlighted a case where a patient experienced hypoventilation after taking an oral ketamine compound outside of a healthcare setting.
The patient’s ketamine blood level was found to be twice the typical level for anesthesia. The FDA listed dissociation and changes in vital signs as potential psychological side effects.
Ketamine is known to increase blood pressure and heart rate, but it can cause a drop in heart rate for patients depleted of catecholamines, which are hormones including dopamine and norepinephrine.
Chronic high-dose ketamine use can lead to bladder damage, resulting in incontinence, urination difficulties, and pain. Psychological risks include impaired cognition, altered perceptions, and the potential for “bad trips” causing fear and confusion.
Long-term ketamine use is associated with memory loss, loss of concentration, and changes in brain structure.
Dr. Gerard Sanacora, a psychiatry professor at Yale University, emphasizes that ketamine is not a standalone treatment for serious mental illnesses.
Despite its popularity as a recreational drug, ketamine is potentially addictive.
Hallucinogen Use: Reaching New Heights
The pandemic has coincided with a surge in recreational drug use, including marijuana and hallucinogens. At the same time, there has been renewed interest in using hallucinogens for mental health treatment.
A recent report from the National Institutes of Health (NIH) revealed that hallucinogen use has reached historic highs, particularly among young adults aged 19 to 30.
Telemedicine has also made previously illegal ketamine prescriptions more accessible, as patients can now receive treatment online without face-to-face meetings.
How does ketamine work differently from traditional psychedelics?
The FDA Warns About the Risks of Compounded Ketamine
The Food and Drug Administration (FDA) issued a warning on Tuesday regarding the dangers associated with compounded ketamine, a type of psychedelic drug.
In recent years, there has been a surge of interest in using ketamine to treat psychiatric illnesses. Unfortunately, illicit use of ketamine is also on the rise.
Despite this growing interest, the FDA emphasizes that there is no evidence to suggest that compounded ketamine is safer, more effective, or faster-acting than FDA-approved medications for psychiatric disorders.
Ketamine is not approved by the FDA for the treatment of any psychiatric disorder. Despite this, compounded ketamine products have been marketed for various psychiatric conditions. However, the FDA has not determined the safety and effectiveness of ketamine for these uses.
What Is Ketamine?
Ketamine is a schedule 3 controlled substance that the FDA has approved for anesthesia induction and maintenance through injection.
Ketamine, a generic anesthetic, has hallucinogenic effects that distort sight and sound perception and create a sense of disconnection from pain and surroundings.
While ketamine is considered a psychedelic due to its impact on perception and environment, it works differently from traditional psychedelics.
Most psychedelics stimulate the brain’s “movers and shakers” responsible for thinking and voluntary movement. In contrast, ketamine inhibits the cells that control these pyramidal cells, resulting in slightly weaker effects.
The FDA has not established a safe or effective dose of ketamine for psychiatric use. However, some healthcare providers prescribe it off-label for certain conditions.
Spravato, a nasal spray containing only S-ketamine molecules, is FDA-approved for treatment-resistant depression and suicidal ideation in adults with major depressive disorder.
Unlike Spravato, compounded ketamine products are not monitored under the FDA’s drug safety program. Therefore, the FDA warns that these products may be less safe.
Healthcare providers and patients should be aware of the potential risks associated with compounded ketamine and consider FDA-approved alternatives for the treatment of psychiatric disorders. It is important to consult a healthcare professional for guidance and to follow their recommendations.
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