The Dangerous Rise of Compounded Ketamine for Anxiety and Depression

At KBD Attorneys, we are closely monitoring a growing trend that poses serious public health and legal concerns: the unsupervised use of compounded ketamine for mental health treatment. Though ketamine has shown promise in treating depression and anxiety, its use—particularly outside of a medical setting—is becoming increasingly common through telemedicine services and compounding pharmacies. Tragically, this practice has led to adverse reactions, hospitalizations, and even death.

If you or a loved one has suffered harm after using compounded ketamine lozenges or other formulations at home, you may have a case. We are actively investigating these incidents and encourage families to reach out.

What Is Ketamine and Is It FDA-Approved for Mental Health Treatment?

Ketamine is a powerful anesthetic that has been used safely in hospital settings for decades. However, its use has expanded in recent years to include off-label treatment for psychiatric conditions like treatment-resistant depression and anxiety. It’s important to understand the difference between what is FDA-approved and what is not:

• FDA-Approved: Ketamine is only approved by the FDA as an anesthetic for surgical procedures. A related compound, esketamine (Spravato), has been approved for certain forms of treatment-resistant depression, but only when administered in certified medical settings with strict monitoring protocols. 
• Not FDA-Approved: Ketamine is often administered off-label via IV or IM (intramuscular) routes in controlled clinical environments for psychiatric purposes. However, compounded forms of ketamine—especially oral or sublingual lozenges—are not FDA-approved, and no safety standards exist for their psychiatric use. 

How Telemedicine Is Fueling the Crisis

In recent years, compounding pharmacies and telemedicine platforms have created a dangerous loophole. Through online prescriptions, patients can now receive sublingual ketamine lozenges shipped to their homes—without ever seeing a doctor in person or undergoing physical exams. This convenience can come at a steep cost.

These telemedicine campaigns often fail to warn users of the life-threatening risks associated with unsupervised ketamine use. In some cases, patients took these lozenges in their homes without medical oversight and suffered adverse reactions, including respiratory depression, dissociation, severe sedation, and even death.

The FDA has already flagged incidents, including the case of a patient who suffered respiratory depression after using oral ketamine at home for PTSD. 

Serious Safety Concerns

Unregulated ketamine use through compounding pharmacies and telemedicine services presents numerous dangers:

• No Established Safe Dosing: Compounded ketamine products have no standardized dosing guidelines. Potency can vary significantly from one batch to another, putting patients at risk of overdose or underdose. 
• Lack of Medical Supervision: Most patients taking these lozenges are not being monitored by licensed professionals, increasing the chances of complications going unnoticed until it’s too late. 
• Inadequate Warnings: Many telemedicine providers fail to properly inform patients of the risks, including psychiatric side effects, dissociation, abuse potential, and long-term organ damage. 
• Physical and Psychological Risks: Ketamine can cause bladder toxicity, high blood pressure, hallucinations, and cognitive dysfunction, especially when taken regularly or without supervision. 

Real Tragedies and the Legal Response

At KBD Attorneys, we are investigating cases involving individuals who have suffered adverse reactions—including death—due to unsupervised compounded ketamine use. These cases often involve:

• Negligent prescribing practices
• Failure to provide informed consent
• Lack of appropriate medical follow-up
• Marketing of ketamine for unapproved uses

If you or a loved one has suffered due to compounded ketamine, you may be entitled to compensation for medical expenses, emotional distress, wrongful death, and more.

Regulatory Warnings and Industry Response

The FDA has issued public warnings to patients and healthcare providers about the use of compounded ketamine for psychiatric disorders. Key takeaways include:

• These products are not FDA-approved.
• Their safety and efficacy have not been evaluated.
• They should only be used in a controlled clinical setting under professional supervision.
• Adverse events should be reported through the FDA’s MedWatch program.

Despite these warnings, compounding pharmacies continue to distribute these drugs and telemedicine platforms continue to prescribe them—often without regard for patient safety or legal liability.

The Role of KBD Attorneys

KBD Attorneys is dedicated to holding negligent parties accountable in cases involving dangerous drugs and unapproved treatments. We have extensive experience in:

• Pharmaceutical litigation
• Product liability
• Medical negligence
• Wrongful death cases

If you or a family member has suffered from complications due to compounded ketamine—especially lozenges obtained through telemedicine—we can help. Our legal team will investigate your case, work with medical experts, and fight for the justice you deserve.

Know the Warning Signs

If you or someone you know is currently taking compounded ketamine, be aware of the following signs of a potentially dangerous reaction:

• Confusion or hallucinations
• Trouble breathing
• Sudden drops in blood pressure
• Intense sedation or blackouts
• Abdominal or bladder pain
• Changes in mood, memory, or personality 

Seek medical attention immediately and report the incident to your doctor and to the FDA.

Related Blogs and Resources

KBD Attorneys frequently publishes legal and safety alerts on dangerous drugs, consumer product recalls, and medical malpractice. You may also be interested in our recent blogs on:

• Marijuana Can Be Life Threatening
• Recent Amazon Product Recalls: Essential Information for Consumers
• Is Medical Malpractice A Personal Injury?

We believe that public awareness is a crucial part of protecting patients from unapproved, unsafe, and unmonitored drug therapies.

Final Thoughts: Stay Informed and Know Your Rights

Compounded ketamine lozenges and similar products are being used well outside of FDA approval—and people are getting hurt. While the medical community and regulatory bodies continue to debate the benefits and risks of ketamine, the lack of oversight in compounded use is putting lives at risk.

If you or a loved one has suffered harm due to ketamine prescribed through telemedicine or dispensed by a compounding pharmacy, contact KBD Attorneys today. Our legal team has the experience and compassion to help guide you through the next steps and fight for the justice you deserve.

Contact KBD Attorneys for a Free Consultation
We’re here to listen. Call us or submit a case inquiry today if you’ve been impacted by unsafe ketamine practices.