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Off-label Prescribing

If you’ve ever visited your clinician and walked out with a prescription, it’s possible that your prescribed medication wasn't approved by the FDA to treat your specific symptoms.

Not to worry – your clinician likely wrote you what’s called an ‘off-label prescription’. Off-label prescribing is both legal and common, and about one in five prescriptions in the U.S. are written off-label.

What is off-label prescribing?

All medications marketed in the U.S. must first be approved for a specific use by the FDA (Food and Drug Administration). The approval process involves the thorough review of clinical data to determine a drug’s efficacy and safety in treating a specific condition or symptom before it can be prescribed to treat said condition or symptom – that is, on-label prescribing. 

Off-label prescribing is when a clinician prescribes a medication in a different way than was explicitly approved by the FDA. There are several ways in which a clinician might prescribe off-label, including:

  • Prescribing a medication to treat symptoms or conditions not included in the FDA approval, such as when a clinician treats a bad cough with medication approved for patients with asthma.

  • Prescribing a medication to be given in a different dose, such as when a medication is approved to be taken once daily but a clinician instructs a patient to take the medication two times each day.

  • Prescribing a medication to be given in a different way, such as when a medication is approved to be administered IM (intramuscular) but is given IV (intravenously).

  • Prescribing medication to a different population or age group than is approved, such as when clinicians prescribe children medication that doesn’t include pediatric-specific information in the medication label.

Why might clinicians prescribe off-label?

Once the FDA approves a medication for one use, it is often discovered to be useful in treating other conditions and symptoms. It can be very expensive to get a drug approved by the FDA for an additional purpose, so this process may not be worthwhile for drug manufacturers (especially once the drug becomes generic). Rather than wait for a medication to be approved for a different use, clinicians may write an off-label prescription where beneficial to the patient and medically appropriate.

The FDA approval process can be both long and costly for the companies tasked with presenting clinical evidence to support specific use of a medication. While it may take years and even decades for clinical studies to warrant FDA approval, prescribing off-label gives clinicians the option of providing patients the medication needed to treat conditions that may not be responsive to on-label options.

In some cases, the FDA will speed up the review process if the medication is identified as especially useful in treating a serious condition with little or no treatment options. For example, esketamine, a component of the ketamine molecule, was recently deemed a breakthrough therapy for treatment-resistant depression, and Spravato (esketamine) nasal spray received FDA approval for this indication in early 2019.

Is off-label prescribing safe?

Off-label prescribing is widely viewed as a safe medical practice. Clinicians are required to be well-informed on any medications they prescribe off-label and should never write a prescription if they do not believe the potential benefits to outweigh any associated risks.

Writing off-label prescriptions is especially common in the field of psychiatry and even encouraged to help advance the science of psychology. The APA (American Psychiatric Association) “affirms strong support for the autonomous clinical decision-making authority of a physician and for a physician’s lawful use of an FDA-approved drug product for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.” (See APA Position Statement on Off-Label Treatments)

Patients curious about their prescription can use online resources like the NIH (National Institute of Health) Library of Medicine to see if their symptoms or condition fall under the “indications and usage” for their prescription medication.

Prescribing ketamine off-label

Ketamine is sometimes prescribed off-label to treat depression, anxiety, chronic pain, PTSD, OCD, and alcohol and substance dependencies. It has safely been used as an FDA-approved anesthetic since 1970. At lower doses, ketamine can induce physical sensations and thought patterns described as psychedelic, which can disrupt negative feelings and obsessional preoccupations.

Get started with a quick online survey to see if you could be a good candidate for ketamine therapy.

The included content does not qualify as medical advice and is not intended to serve as such. Discuss any prescription medications you are taking or plan to take with your primary care physician.