FDA warns that much of ‘ketamine therapy’ appears to be just a party

Shocking news: All that “ketamine therapy” your friend has been doing might actually just be a party, really.

Ketamine, a dissociative anesthetic known for its psychedelic effects, has had a big year. Thanks in large part to its famous fans, a list that includes SpaceX honcho Elon Musk, the number one ketamine billionaire, the compound has skyrocketed in mainstream popularity, with its supporters claiming that the psychotropic drug is an effective therapeutic treatment for treating psychiatric disorders ranging from depression to post-traumatic stress disorder.

Through various telemedicine platforms, the drug is widely available online; sit down for a brief video call, and depending The New York Timesa hopeful participant may receive more than 30 doses of ketamine in the form of pills, sprays or lozenges.

But as eager as online sellers are to sell their ketamine lollipops, America’s drug daddy is here to remind us that the famous horse drug is still unregulated.

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a warning stating that no compounded version of ketamine, that is, a version of ketamine that, like other drugs, is mixed or modified to suit an individual patient, according to the FDA, has not been generally approved for the “treatment of any psychiatric disorder.”

So, in other words, if you buy so-called therapeutic ketamine through an online supplier, it’s less like using telemedicine to receive prescription antidepressants, and a little more like… well, just buying some ordinary party drugs.

And according to the FDA’s warning, the danger here doesn’t just lie in the pharmaceutical Wild West. Certainly, given the lack of FDA approval, the safety and effectiveness of in-person ketamine sessions is up for debate. But in a clinical setting, there is at least some supervision that a professional can step in if someone has a bad reaction to medication, for example. In contrast, those who purchase the drug online are very likely to take it without any professional supervision, a reality that amplifies the very real risks of ketamine.

These risks should not be neglected. As the FDA noted in its warning, the drug’s potential side effects include “abuse and misuse.” Ketamine is a recreational drug, after all, and is known to be addictive as well as “psychiatric events, increased blood pressure, respiratory depression (slowed breathing), and lower urinary tract and bladder symptoms.

The FDA also warns that online sellers may be less likely to provide buyers with “important information about potential risks associated with the product.” Which obviously isn’t great.

To be clear, ketamine isn’t exactly illegal. It is classified as a Schedule III non-narcotic under the Controlled Substances Act, and there is a version that has was approved for therapeutic purposes: esketamine, a nasal spray specially authorized in 2019 to treat depression when other antidepressants fail. And, generally speaking, we would be remiss not to note that psychedelics appear to offer fascinating and exciting therapeutic benefits in clinical settings.

But buying Some Guy’s Ketamine over the Internet is simply not the same as receiving professionally controlled and administered clinical treatments, and some of those who believe in the drug as a life-changing therapeutic fear that the market will Unregulated line won’t derail that hope. for future FDA approval.

“Our concern is that these online sellers are going to ruin everyone’s lives,” Peter Koshland, who owns a compounding pharmacy in San Francisco, told the newspaper. New York Times.

“Our fear is that regulators, if they perceive a threat to public health,” Koshland added, “will pull back from this incredible drug and leave patients at risk.”

Learn more about ketamine: Startups have a fun new idea: workplace ketamine sessions