In a straightforward term, the U.S. Food and Drug Administration (FDA) is urging folks to tread cautiously with a drug called ketamine.
Not all versions of it are safe, especially when cooked up without official oversight. Here’s a breakdown of the why and the how.
Understanding Ketamine: The What and Why
Ketamine is a drug often utilized for several purposes – it can help people sleep before surgery and also has a role in treating certain mental health issues, like depression or anxiety.
However, not all ketamine is created equal. There’s the type officially checked and approved by health authorities (like the FDA) and the kind mixed or altered outside these regulations, often referred to as “compounded” ketamine.
Recently, more folks have been turning to this compounded ketamine to manage psychiatric disorders, but doing so brings its own set of risks.
In April, a concerning incident involved a person using compounded ketamine at home to manage post-traumatic stress disorder (PTSD).
Unfortunately, it resulted in slowed breathing and a dangerously high level of ketamine in their blood – twice the typical amount given even in a controlled, medical situation.
Why Official Approval Matters: Safety First
When a drug gets the FDA’s green light, it means it’s undergone a series of checks and balances to ensure it’s safe and does what it’s supposed to.
Compounded ketamine hasn’t gone through this process, making it a bit of an unknown entity. That means there’s no guarantee it’s safe or will work as intended.
Spravato, for instance, is a form of ketamine (specifically, it contains a molecule called esketamine) that has been approved by the FDA.
It’s a nasal spray used, alongside an antidepressant, to tackle treatment-resistant depression in adults and is dispensed with strict guidelines to manage its side effects and risk of misuse.
These checks are there to guard against the potentially harmful impacts and misuse of the drug.
Usage without Oversight: A Risky Endeavor
Obtaining and using compounded ketamine might seem attractive to some, especially when facilitated easily through online platforms.
However, administering these products at home without a healthcare professional is risky because nobody’s there to monitor for any bad reactions or misuse.
In the medical world, monitoring is key. With something like ketamine, which can alter a person’s senses and even their consciousness, without keeping a close eye on vital signs such as blood pressure and heart rate, things could take a dangerous turn.
The FDA emphasizes that there’s scant information on the proper dosing of compounded ketamine, further elevating its risk when used outside a healthcare setting.
Recognizing the potential hazards and ensuring stringent checks, like in the case of approved versions of ketamine, is vital to strike a balance between making innovative treatments available and safeguarding public health.
The FDA, standing as a watch-guard to evaluate and vet the safety of drugs, continuously emphasizes the importance of sticking to approved and regulated drugs.
It provides a safety net, ensuring that the benefits of a drug truly outweigh the risks and allowing healthcare professionals to monitor and manage any untoward reactions effectively.
In light of these concerns, the agency encourages anyone who’s experienced negative side effects from compounded ketamine to step forward and report it through the FDA’s MedWatch Adverse Event Reporting Program.
This enables them to keep a watchful eye on the situation, stepping in when necessary to protect the public from any emerging threats to their health and wellbeing.
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