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When medicine is prescribed off-label, many patients worry about safety, particularly with ketamine. Though ketamine has been used as an FDA-approved anesthetic since 1970, it may be prescribed as off-label when used therapeutically for anxiety, depression, PTSD, chronic pain, OCD, and substance dependencies. This is because several studies over the years have shown that low doses of ketamine have the potential to disrupt negative thought patterns and obsessions in the brain.
On March 5, 2019, esketamine CIII nasal spray (Spravato; Janssen Pharmaceuticals) was approved by the US Food and Drug Administration (FDA), in conjunction with an oral antidepressant, for the treatment of adults with treatment-resistant depression.
When a clinician uses an off-label prescription, it means it wasn’t approved by the FDA (Food and Drug Administration) to treat your specific symptoms, but that doesn’t indicate danger. About one in five prescriptions in the U.S. are actually written off-label, and the practice is both legal and safe.
The American Psychiatric Association (the oldest medical association in the country, founded in 1844) has confirmed that, when used in low doses, ketamine is a “both rapid and robust” treatment for depression and suicidal ideations.
The FDA approval process is long and thorough, reviewing all clinical data to gauge a drug’s efficacy and safety for treating a specific condition or symptom. Every medication used and marketed in the U.S. must pass approval for a specific use. This is known as on-label prescribing.
Once a drug is approved and prescribed to a larger number of people, clinicians may discover it proves effective for treating additional symptoms in patients. For example, beta blockers were originally approved to treat high blood pressure, but they are now commonly used off-label for heart failure and to prevent migraines. Doctors may also find that a patient needs a different dose or a different way of receiving approved medicines, also deemed off-label use.
Reasons a drug may be prescribed off-label include:
The FDA approval process is lengthy and expensive. If off-label prescribing wasn’t allowed, patients might have to wait years to get the medicine they need to improve their lives. After discovering that a medicine can treat a different condition, a clinician can decide that it’s more beneficial to the patient to write an off-label prescription now instead of waiting years or decades for additional approval.
Sometimes, the FDA speeds up the review of a medication if it’s found to treat a serious condition that has little or no other treatment options. Esketamine, a component of the ketamine molecule, was recently found to help treatment-resistant depression, so Spravato (an esketamine nasal spray) was fast-tracked by the FDA and given breakthrough therapy designations before being approved in early 2019.
Clinicians are required to be well-informed on all medications they prescribe off-label, weighing the benefits and risks. This practice is widely seen as safe. Off-label prescriptions are especially common in psychiatry, even encouraged, to advance patient wellbeing. The APA (American Psychiatric Association) supports the “decision-making authority of a physician and for a physician’s lawful use of an FDA-approved drug product for an off-label indication.”
Ketamine is an FDA-approved drug as an anesthetic. Ketamine is not FDA-approved to treat mental health conditions. The off-label use of ketamine to treat anxiety and mood disorders is supported by a growing body of research. Patients worried about their prescription being off-label can take solace in the fact that ketamine therapy is consistent with medical standards and regulations, supported by appropriately-trained physicians.
Integration Director and L.P.C.
