FDA issues warning on ketamine misuse | ET REALITY

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

Compounded medications are those that have been modified or adapted in a laboratory for the specific needs of an individual patient.

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

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

“Patients receiving compounded ketamine products from compounding manufacturers 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 federally approved ketamine nasal spray for treatment-resistant depression, psychiatric use of ketamine is not approved or regulated, although so-called off-label use of ketamine is not illegal.

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

But the regulatory vacuum has also opened the door to growing abuses. Ketamine can be addictive and heavy and prolonged use can cause significant, even irreversible, health problems. urinary tract damage.

The pandemic-related telehealth boom has given rise to a legion of online prescribers who dispense low-cost ketamine pills, tablets or nasal sprays after a brief video interview. Some companies provide up to 30 doses after one session, which experts say can lead to misuse.

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

Compounding industry executives said they welcomed government oversight but expressed concern that a lack of nuance in FDA guidelines could lead to excessive crackdowns by state regulators, who have jurisdiction. on the country’s pharmaceutical compounding facilities.

“Our concern is that these online sellers will ruin it for everyone,” said Peter Koshland, who runs a compounding pharmacy in San Francisco. “Our fear is that regulators, if they perceive a threat to public health, will act to withdraw this wonderful drug and leave patients at risk.”

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

The FDA declined to make an official available for an interview.

Dr. Steven Radowitz, medical director of nushama, a ketamine clinic in New York City that administers the drug by injection, said it hoped the alert would help patients differentiate between companies that sell the drug online and those whose treatments are accompanied by strict supervision. At Nushama, he said, the treatment protocol includes six ketamine treatments over the course of three weeks and an in-house staff that includes doctors, nurse practitioners and therapists.

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

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