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What is Off-Label Use of Ketamine?

Ketamine was first synthesized in 1962, and approved by the FDA in 1970 for use as an anesthetic. You may have heard that ketamine is sometimes also prescribed off-label in the treatment of mental health disorders like anxiety or depression. But what does “off-label” mean? Read on to find out.

What Does “Off-Label” Mean?

When a doctor prescribes a drug for a condition other than what it’s approved for, it’s called an off-label use. Not only is this legal, but according to WebMD, over 20% of US prescriptions are for off-label therapies.

The US Food and Drug Administration (FDA) controls which drugs doctors can prescribe. But it does not control what conditions an approved drug can be prescribed for.

Is It Safe to Use “Off-Label” Drugs?

An off-label therapy isn’t an experimental therapy. Your doctor isn’t working off a hunch. In fact, a treatment’s safety and efficacy may already be well-established in scientific literature. For example, the safety and efficacy of ketamine for depression first appeared in medical journals way back in 2000.

Prescribing off-label is actually quite common. For example, Gabapentin has been approved for use as an anti-seizure medicine, but is used off-label to treat anxiety and insomnia.

Ketamine as “Off-Label” Medicine

The benefits of ketamine as a psychedelic therapy are widely acknowledged. So why is ketamine yet to receive full FDA approval?

It’s difficult to get approval for a medicine. The process is long and expensive. And pharma companies only make money if they can sell the drug at a high price.

Ketamine is a generic drug, so no one company would benefit from expanding its approved use. But your doctor can prescribe ketamine if they believe it will benefit you.

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