food and drug administration issued an alarm Ketamine is a powerful anesthetic that is becoming increasingly popular among people seeking alternative treatments for depression, anxiety, post-traumatic stress disorder, and other hard-to-treat mental health problems.
Complex drugs are drugs that have been modified or adjusted in the laboratory to meet the specific needs of individual patients.
Citing reports of adverse events it has received, the agency says supervised use of compounded ketamine can lead to dangerous psychological reactions and health problems, including increased blood pressure, respiratory depression, and urinary tract problems that can lead to incontinence. He warned that it would increase the risk of problems.
The warning applies to supervised use of ketamine as a psychiatric therapy administered in clinics or “wellness centers,” as well as online sellers who prescribe ketamine via telemedicine so that buyers can take the drug at home. I’m trying to differentiate between.
“Patients who receive compounded ketamine products from compounders or telemedicine platforms for the treatment of mental illness may not receive important information about the potential risks associated with the product,” the FDA said. stated in the warning.
With the exception of esketamine, a federally approved ketamine nasal spray for treatment-resistant depression, psychiatric uses of ketamine are unapproved and unregulated, but so-called off-label uses of ketamine are not illegal. .
Since Ketamine was first approved as a battlefield anesthetic in 1970, it also gained popularity as Special K, a club drug that is usually inhaled. More recently, there has been an explosion in treatment with ketamine injections, with many reporting breakthrough advances in patients with difficult-to-treat mental health problems, in a small but growing number of cases. This is driven by a series of research studies.
However, the regulatory vacuum also opens the door to increased fraud. Ketamine can be addictive, and long-term use in large doses can cause serious health problems, including irreversible. urinary tract injury.
The pandemic-related telemedicine boom has spawned a slew of online prescribers dispensing inexpensive ketamine lozenges, pills and nasal sprays after a brief video interview. Some companies are offering up to 30 doses after one session, which experts say could lead to misuse.
“Every time there’s something new, there may be people who get ahead of it and do things based on less evidence, not more evidence.” said Dr. Joshua Berman, medical director of interventional psychiatry at Columbia University and who helped develop the department’s ketamine program.
Pharmaceutical compounding industry executives said they welcome government oversight, but the lack of nuance in the FDA’s guidance could lead to over-policing by state regulators of the nation’s compounding facilities. He expressed concern that there is.
“Our concern is that these online sellers are going to ruin everyone’s lives,” said Peter Koshland, who owns a pharmacy in San Francisco. “Our fear is that if regulators see a threat to public health, they will move to take away this wonderful drug and put patients at risk.”
The FDA warning did not include data on side effects in ketamine users. The report cited one case in April of a patient with post-traumatic stress disorder who experienced respiratory depression after taking combination oral ketamine outside of a medical setting. The patient’s blood ketamine levels were twice the amount normally used for anesthesia, the agency said.
The FDA declined to speak with officials.
Dr. Steven Radowitz, Chief Medical Officer NshamaA New York City ketamine clinic that administers the drug by injection hopes the warning will help patients distinguish between companies selling the drug online and those receiving treatment under strict supervision. He said he is doing so. At Nshama, he said, the treatment protocol includes six ketamine treatments over three weeks and in-house staff, including doctors, nurses and therapists.
“Nobody goes home with ketamine,” Dr. Radowitz said. “And that’s the way it should be.”
