FDA Issues Warning Regarding Misuse of Ketamine
Unsupervised treatment – fueled by telemedicine prescriptions – for various psychiatric problems poses a number of health risks, the agency said.
The Food and Drug Administration issued a warning Tuesday about the dangers of treating psychiatric disorders with compound versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety and post-traumatic stress disorder. stress disorder and other difficult-to-treat mental health problems.
Compounded medications are those that have been modified or adapted in the laboratory for the specific needs of an individual patient .
The agency, citing reports of adverse incidents, warned that unsupervised use of compounded ketamine increased the risk of dangerous psychiatric reactions and problems such as increased blood pressure, respiratory depression and urinary tract problems which 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 marketers who prescribe the drug via telemedicine so buyers can take it at home. /p>
“Patients who receive compound ketamine products from compounders and telemedicine platforms for the treatment of psychiatric disorders may not receive important information about potential risks associated with the product,” the F.D.A. said in its warning.
With the exception of esketamine, a federally approved ketamine nasal spray for treatment-resistant depression, the use ketamine is not approved or regulated, although off-label use of ketamine is not illegal.
Since it was First approved as a battlefield anesthetic in 1970, ketamine also gained popularity under the name Special K, a club drug usually snorted. More recently, there has been an explosion in ketamine-assisted therapy, largely fueled by a small but growing body of research reporting breakthroughs in patients with difficult-to-treat mental health problems.
But the regulatory void has also opened the door to a rise in abuse. Ketamine can be addictive, and heavy, long-term use can lead to significant health problems, including irreversible damage to the urinary tract.
The ketamine boom Telehealth linked to the pandemic has given rise to addiction. to a legion of online prescribers who dispense cheap ketamine lozenges, tablets 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.
“Every time you have something again, there may be people moving forward with 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 program. of ketamine from the department.
Pharmaceutical compounding industry executives said they welcomed government oversight but expressed concern about fact that a lack of nuance in FDA guidance could lead to overzealous enforcement by state regulators, who have jurisdiction over the nation's compounding facilities.
"Our concern is that these online sellers are going to ruin everyone's lives," said Peter Koshland, who runs a compounding pharmacy in S...
Unsupervised treatment – fueled by telemedicine prescriptions – for various psychiatric problems poses a number of health risks, the agency said.
The Food and Drug Administration issued a warning Tuesday about the dangers of treating psychiatric disorders with compound versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety and post-traumatic stress disorder. stress disorder and other difficult-to-treat mental health problems.
Compounded medications are those that have been modified or adapted in the laboratory for the specific needs of an individual patient .
The agency, citing reports of adverse incidents, warned that unsupervised use of compounded ketamine increased the risk of dangerous psychiatric reactions and problems such as increased blood pressure, respiratory depression and urinary tract problems which 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 marketers who prescribe the drug via telemedicine so buyers can take it at home. /p>
“Patients who receive compound ketamine products from compounders and telemedicine platforms for the treatment of psychiatric disorders may not receive important information about potential risks associated with the product,” the F.D.A. said in its warning.
With the exception of esketamine, a federally approved ketamine nasal spray for treatment-resistant depression, the use ketamine is not approved or regulated, although off-label use of ketamine is not illegal.
Since it was First approved as a battlefield anesthetic in 1970, ketamine also gained popularity under the name Special K, a club drug usually snorted. More recently, there has been an explosion in ketamine-assisted therapy, largely fueled by a small but growing body of research reporting breakthroughs in patients with difficult-to-treat mental health problems.
But the regulatory void has also opened the door to a rise in abuse. Ketamine can be addictive, and heavy, long-term use can lead to significant health problems, including irreversible damage to the urinary tract.
The ketamine boom Telehealth linked to the pandemic has given rise to addiction. to a legion of online prescribers who dispense cheap ketamine lozenges, tablets 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.
“Every time you have something again, there may be people moving forward with 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 program. of ketamine from the department.
Pharmaceutical compounding industry executives said they welcomed government oversight but expressed concern about fact that a lack of nuance in FDA guidance could lead to overzealous enforcement by state regulators, who have jurisdiction over the nation's compounding facilities.
"Our concern is that these online sellers are going to ruin everyone's lives," said Peter Koshland, who runs a compounding pharmacy in S...
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