Yes, ketamine has FDA approval

Is Ketamine FDA Approved?

Ketamine is an FDA-approved drug that may be used by physicians for anesthesia and for other uses off-label.

What Does FDA Mean?

FDA approval is given to a medication after it has been studied for both safety and efficacy for a particular indication.

Ketamine has FDA approval as an anesthetic for the induction and maintenance of general anesthesia. It was given this approval back in 1970 after development and study throughout the 1960s.

Off-label Uses

Even though ketamine has an FDA approval for one indication, we are able to use it for other indications as well. When a drug is FDA approved, doctors are able to use it for other indications as an off-label use. Around 20% of all medications are used in this off-label manner. For example, if you know someone who is on propranolol for tremors, or for anxiety, or for PTSD, then you know someone who is taking a medication for an off-label indication. Propranolol is FDA indicated for blood pressure.

It takes many years and a lot of money to pursue FDA indication for a medication. For this reason, most medications don’t seek approval for another indication after initially gaining FDA approval. Doctors are able to use a medication that has an FDA indication for a different indication if they believe it is warranted. If a doctor believes that a medication will be useful, and especially if they have studies and evidence in support, they may use that approved medication.

While ketamine does not have an FDA indication for use in treating depression and other mood disorders and pain conditions, this use is well-studied, and demonstrated to yield excellent results. Ketamine can be very effective, and has a very safe profile. When administered in a clinical setting with appropriately trained professionals, it can be an exceptional treatment option.

Dr Wells discusses FDA approval more in this post: The Difference Between FDA Approval and Insurance Coverage

About Us

Wells Medicine is a Houston-based practice designed to provide meaningful care for mental health. Providing targeted interventional treatments for Depression, Anxiety, OCD, PTSD and other conditions, with Ketamine Treatments, Stellate Ganglion Blocks, TMS, and Nitrous-Oxide Treatments. Focused on comprehensive care and integration with Psychiatry, Psychology, and Support Services. We are evidence-based, patient-focused and mission-driven.

The content here is for informational purposes and should not be relied upon for medical decisions. For the details of your specific medical conditions and treatments consult your doctors or other qualified healthcare professionals.