Misuse of ketamine causes US agency to issue warning – 10/12/2023 – Health

The Food and Drug Administration (FDA) issued a warning on Tuesday about the dangers of treating psychiatric disorders with manipulated versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking therapies. alternatives for depression, anxiety, post-traumatic stress disorder and other difficult to treat mental health problems.

Compounded medicines are those that have been modified or adapted in the laboratory to meet the specific needs of an individual patient.

The agency, citing reports it has received of adverse incidents, warned that unsupervised use of compound ketamine increases the risk of dangerous psychiatric reactions and health problems such as increased blood pressure, respiratory and urinary tract problems that can lead to incontinence.

The warning sought to differentiate the supervised use of ketamine as a psychiatric therapy administered in clinics and “wellness centers” and online sellers who prescribe the drug via telemedicine so that patients can take it at home.

“Patients receiving compounded ketamine products through compounders and telemedicine platforms for the treatment of psychiatric disorders may not receive important information about the potential risks associated with the product,” the FDA said in its warning.

With the exception of esketamine, a ketamine nasal spray approved by the US government for treatment-resistant depression, psychiatric use of ketamine is neither approved nor regulated, although so-called “off-label” use of ketamine is not illegal.

Since it was first approved as an anesthetic in 1970, ketamine has also gained popularity as Special K, a party drug that is often snorted. More recently, there has been an explosion in injected ketamine-assisted therapy, much of it driven by a small but growing body of research reporting advances among patients with difficult-to-treat mental health problems.

But the regulatory vacuum also opened space for increasing abuses. Ketamine can be addictive and heavy, prolonged use can lead to significant health problems, including irreversible damage to the urinary tract.

The huge rise in telemedicine during the Covid-19 pandemic has given rise to a legion of online prescribers prescribing cheap ketamine lozenges, pills or nasal sprays after a brief video interview. Some companies provide up to 30 doses after a session, which experts say can lead to misuse.

“Whenever you have something new, there may be people who get ahead of it. And there will be people who do things based on less evidence rather than more,” said Joshua Berman, medical director of interventional psychiatry at Columbia University, who helped developing the department’s ketamine program.

Pharmaceutical compounding industry executives said they welcomed government oversight but expressed concern that a lack of subtlety in the FDA’s guidance could lead to excessive crackdowns by state regulators, which have jurisdiction over the nation’s compounding facilities.

“Our concern is that these online sellers are going to end up ruining everything for everyone,” said Peter Koshland, who runs a compounding pharmacy in San Francisco. “Our fear is that regulators, if they see a threat to public health, will act to withdraw this incredible medicine and leave patients at risk.”

The FDA warning did not include data on adverse reactions among ketamine users. It cited a single case from April of a patient with post-traumatic stress disorder who experienced shortness of breath after taking compounded oral ketamine outside of a healthcare setting. The level of ketamine in the patient’s blood, according to the agency, was twice the amount normally used in anesthesia.

The agency declined to make an agent available for an interview.

Steven Radowitz, chief medical officer at Nushama, a ketamine clinic in New York City that administers the drug via injection, said he hoped the alert would help patients differentiate between companies that sell the drug online and those whose treatments are tracked. by strict supervision. At Nushama, he said the treatment protocol includes six sessions of the medicine over three weeks, and an in-house team that includes doctors, nurses and therapists.

“No one goes home with ketamine,” Radowitz said. “And that’s how it should be.”