Patients and people who work in health care

10/10/2023 — More people are interested in blended ketamine goods, such as liquid versions, for treating mental illnesses. This is what people and health care workers should know about blended ketamine products:

• Ketamine has not been cleared by the FDA to treat any mental illness. The FDA knows that combined ketamine products have been sold to treat a wide range of mental illnesses, such as sadness, anxiety, PTSD, and obsessive-compulsive disorder. However, the FDA has not yet decided that ketamine is safe and useful for these uses.
• Compound drugs, such as ketamine products that have been mixed with other chemicals, are not cleared by the FDA. This means that the FDA has not checked their safety, usefulness, or quality before putting them on the market. Because of this, blended drugs don’t have any allowed uses or ways of being administered by the FDA. Compound drugs can be very helpful for some people when an FDA-approved drug is not right for them. However, they are dangerous and should only be used with the supervision of a medical professional of some kind.
• People who use compounded ketamine products without being watched by a medical professional for sedation (feeling sleepy), dissociation (losing touch with their own thoughts, feelings, and sense of time, space, and self), and changes in vital signs (like blood pressure and heart rate) may be more likely to have serious side effects.
• It is known that abusing or misusing ketamine products can lead to mental events, high blood pressure, respiratory depression (slow breathing), and problems with the lower urinary system and bladder. When FDA-approved ketamine (see Ketalar prescription information) is used at the right amounts for FDA-approved reasons and methods of administration, the predicted benefit is greater than the risks.
• Additionally, there is more interest in compounded ketamine, but there is no proof that it is better, more effective, or works faster than FDA-approved drugs for treating certain mental conditions.

BACKGROUND

Ketamine hydrochloride, which is just called “ketamine” here, is a Schedule III controlled drug that is allowed by the FDA as an injection solution that can be given through an IV or a muscle to start and maintain general anesthesia. Like many drugs, ketamine is made up of two molecules that are mirror images of each other: R-ketamine and S-ketamine, which are also known as arketamine and esketamine. The chemical esketamine alone in Spravato is allowed as a nasal spray for adults with depression that doesn’t respond to other treatments and for adults with major depressive disorder who are depressed and having suicide thoughts or acting on them (along with a tablet antidepressant).

On February 16, 2022, the FDA released a compounding risk warning that talked about the possible risks of using made ketamine nasal spray at home and included a number of reports of adverse events. The February 2022 compounding risk warning also talked about Spravato, which needs to go through a Risk Evaluation and Mitigation Strategy (REMS) in order to get FDA clearance. A REMS is a drug safety program that the FDA can require for some approved drugs that pose major safety issues. This is done to make sure that the benefits of the drug are greater than its risks. The Spravato REMS says that esketamine can only be given out and used in medically supervised health care settings that are trained in the REMS and agree to watch over patients for at least two hours after giving it to them. This is because it can make people sleepy or dissociative, and it can also be abused or misused. Because they are not FDA-approved for any use, including mental illnesses, compounded ketamine drugs are not part of a REMS program. This doesn’t mean that ketamine drugs that are mixed together are safer for patients. In fact, blended ketamine goods may not be as safe as they seem because they are not regulated by a REMS.

Since the February 2022 compounding risk warning came out, the FDA has learned that more and more people are interested in using sublingual and oral dose types of compounded ketamine to help mental illnesses. FDA knows that some patients may be interested in being able to get these kinds of goods through online systems and compounders to use at home. But patients may be at risk because there isn’t a health care worker on-site to watch for bad things like sleepiness and confusion. The FDA has also found safety issues with mixed ketamine goods, which we will talk about below. Also, because ketamine hasn’t been cleared for these uses, the FDA hasn’t set any safe or useful doses for any mental reason. Because of these things, the patient may be more likely to have major side effects, be abused, or misused.

Possible risks to safety that come with compounded ketamine products

People who get made ketamine products from compounders and online platforms to help mental illnesses might not get important information about the risks that come with the products. As was already said, there are safety concerns about ketamine products. These include, but aren’t limited to, the possibility of sedation, dissociation, psychiatric events or worsening of psychiatric disorders, abuse and misuse, higher blood pressure, respiratory depression (breathing slows down and shallower, and the lungs don’t exchange carbon dioxide and oxygen as well), and problems with the lower urinary tract and bladder. When compounded ketamine is given at home, there are extra risks because there is no health care worker nearby to watch for dangerous side effects from drowsiness and confusion.

In April 2023, the FDA got a report of a bad event involving a patient who took compounded oral ketamine outside of a health care setting to treat PTSD and experienced breathing problems. The amount of ketamine in the patient’s blood seemed to be twice what is usually found for anesthesia.

Aside from the possible risks, patients and health care workers should know that there isn’t a lot of information out there about how to use blended ketamine goods. For instance, the FDA has not set a safe or useful dose of ketamine for any clinical use. Also, the amounts of sublingual and oral compounded ketamine sold by compounders and telemedicine platforms can be different, which makes it hard to guess what risks might be connected with these products. Concerns have been raised about the short-term use of combined ketamine, and no one knows what the total benefits and risks are of using ketamine to help mental illnesses.

In conclusion

The FDA is aware that there is more interest in using made ketamine products, such as liquid versions, to treat mental illnesses at home. Patients and health care providers should know that the FDA has found possible safety issues with using compounded ketamine products from compounders and telemedicine platforms. These include abuse and misuse, psychiatric events, higher blood pressure, breathing problems, and problems with the lower urinary tract and bladder. Using made ketamine products at home is even riskier because you can’t have a health care worker watch over you. Furthermore, the FDA has not approved ketamine for the treatment of any psychiatric disorder. More clinical studies are required to fully understand ketamine’s benefit-risk profile and safe-use conditions in the treatment of psychiatric disorders. The FDA encourages compounders, patients, and health care providers to report any adverse events related to compounded ketamine products to the MedWatch Adverse Event Reporting program.

• Fill out the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program and send it in; or
• Download the form, fill it out, and fax it to 1-800-FDA-0178.

FDA is the source.