FDA Issues Warning on Use of Psychedelic Drug

In recent years, there has been a growing interest in ketamine use for treating psychiatric illnesses. Illicit ketamine use is also on the rise.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The Food and Drug Administration (FDA) on Tuesday warned patients and health care providers about the risks associated with compounded ketamine, a type of psychedelic.

In recent years, there has been a growing interest in ketamine use for treating psychiatric illnesses. Illicit ketamine use is also on the rise.

“Despite increased interest in the use of compounded ketamine, we are not aware of evidence to suggest that it is safer, is more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders,” the FDA wrote in a statement.

“Ketamine is not FDA approved for the treatment of any psychiatric disorder. FDA is aware that compounded ketamine products have been marketed for a wide variety of psychiatric disorders … however, FDA has not determined that ketamine is safe and effective for such uses.”

What Is Ketamine?

Ketamine is a schedule 3 controlled substance that the FDA approved as an injection for induction and maintenance of anesthesia.

A generic anesthetic, ketamine has hallucinogenic effects. The drug distorts the perception of sight and sound and makes a person feel disconnected from their pain and environment.

Some doctors consider ketamine a psychedelic since users may experience changes to the perception and sense of their environment, characteristic of psychedelic drugs. However, ketamine works differently from traditional psychedelics.

Most psychedelics create extrasensory effects by overstimulating the pyramidal cells, the brain’s “movers and shakers“ responsible for thinking and voluntary movement. Ketamine produces slightly weaker effects by inhibiting the cells that control pyramidal cells, thereby releasing the pyramidal cells from control.

The FDA has not established a safe or effective dose of ketamine, which is a mixture of both R and S ketamine molecules, for any psychiatric uses. However, some health care providers prescribe it for off-label use to treat such conditions.

Spravato, which only includes the S-ketamine molecules, is approved as a nasal spray for treatment-resistant depression and suicidal ideation and behavior in adults with major depressive disorder.

Spravato must be dispensed and administered in medically supervised health care settings certified in the FDA’s drug safety program. Since compounded ketamine products are not monitored under the drug safety program, the FDA claims the products may be less safe.

Health Risks of Ketamine

In the warning, the FDA cited an adverse event report of a patient who experienced hypoventilation after taking an oral ketamine compound outside a health care setting.

“The patient’s ketamine blood level appeared to be twice the blood level typically obtained for anesthesia,” the FDA wrote. The agency listed potential psychological side effects as dissociation, a disconnection between a person’s thoughts, feelings, sense of space, time, and self, and changes in vital signs.

Ketamine is typically associated with an increase in blood pressure and heart rate. However, patients who are depleted of catecholamines, a group of hormones including dopamine and norepinephrine, can experience a drop in heart rate when they take ketamine. Catecholamine depletion is a common side effect of antidepressants.

Another severe potential health consequence is bladder damage. People who chronically take high doses of ketamine can develop incontinence and difficulties and pain with urination.

Ketamine also bears psychological risks.

“It has significant effects on cognition, meaning that you’re no longer thinking clearly at all,” Dr. Gerard Sanacora, a professor of psychiatry at Yale University, said in an interview with Yale. “It can also dramatically alter perceptions. People can hear things differently, see things differently, feel things differently—this can be really scary to some people and cause them to act differently than they would without the drug in their system.”

Being under the influence of hallucinogens is considered “tripping.” Reactions to a “bad trip” can cause fear, confusion, or panic. Additionally, ketamine may leave a person with amnesia once their trip has ended, and long-term use is associated with memory loss and loss of concentration. Studies have shown that chronic use of ketamine can also change brain structure.

Dr. Sanacora added that ketamine is not a miracle cure for serious mental illnesses.

“This is not a treatment to be given in isolation. All of the studies presented for consideration of FDA approval were done with very close psychiatric follow-up. It is incredibly naïve and uninformed to think ketamine alone will make your depression go away. It’s a part of a treatment plan, not the treatment plan.”

Despite being a popular recreational drug for decades, ketamine is potentially addictive.

Hallucinogen Use: A Historic High

The pandemic coincided with a rise in recreational drugs like marijuana and hallucinogens. Simultaneously, there has been renewed interest in using hallucinogens to treat mental health problems.

A recent report released by the National Institutes of Health (NIH) showed that usage of drugs has climbed to historic highs. The use of hallucinogens rose to 8 percent for 19-to-30-year-olds. In 2017, around 5 percent of Americans in this age range used hallucinogens.

People aged 35 to 50 saw a historic rise in hallucinogen use, doubling since 2021, with around 4 percent reporting usage of hallucinogens in 2022.

Telemedicine has also made previously illegal prescriptions of ketamine more readily available. Since the pandemic, permanent regulations have allowed patients to receive treatment from health practitioners online and even from other states instead of requiring face-to-face meetings.