Understanding Off-Label Medication Use in Psychiatry


An Overview of

Understanding Off-Label Medication Use in Psychiatry

When treating a disease, medication is a valuable tool. Physicians choose medications based on the intention to “Do No Harm”, which is why most patients trust their physicians when it comes to their health issues. You may consider all medications as good and beneficial in treating a problem, but it’s important to understand what medications are intended for and how to use them appropriately. In this material, we will share some of the concepts of ‘label’ vs ‘off label’ medications.


  • Label Use- Drug indication refers to the use of a particular drug for treating a specific disease. It is also called “labeled use.” It is regulated by the U.S. Food and Drug Administration (FDA) and essentially means that drugs are approved only for a specific use, not for universal treatment. For example, medication Celexa (Citalopram HBr) is indicated for the treatment of depression which means Celexa is a FDA approved drug for treating depression only.
  • Off-Label Use- means prescribing a pharmaceutical medication for an unapproved indication or unapproved age group, unapproved dose or unapproved form of administration. For example, Celexa (Citalopram HBr) is indicated for the treatment of depression but has been used off-label for the treatment of anxiety disorder.

The use of off-label medication is legal in the United States. But it is illegal for drug companies to market their drugs for off-label use.


Off-label use of medication is not an unusual practice in medicine. Physicians have prescribed medications for diseases or conditions that don’t have FDA approved indications. This practice is typically not the first choice and these decisions are made under special circumstances and are usually backed by some scientific evidence. The practice of using a medication for an off label indication is also seen in Psychiatry.


Both the provider and patient play an important role when it comes to the patient’s health care. A patient’s responsibility is to ask questions to the provider so that he can take better care of his health. Here is a list of questions to ask your physician:-

  • What is the diagnosis?
  • How did the physician come to that diagnosis?
  • Understand the reason behind choosing a treatment medication.
  • Is the medication FDA approved?
  • If the medication is off-label, then ask if there is any scientific evidence to support such a use and whether the provider has any experience using the medication for similar problems in the past?
  • What does the medication do?
  • When and how should I take it? When and how should I stop taking it?
  • Will it interact with other medications that I take?
  • What are the side effects? What should I do if I experience them?

Medication review can be done at the Food and Drug Administration (FDA) website.


  • Regulating Off-Label Drug Use — Rethinking the Role of the FDA — NEJM – http://www.nejm.org/doi/full/10.1056/NEJMp0802107 – Accessed March 27, 2013.
  • NIMH · What should I ask my doctor if I am prescribed a psychiatric medication – http://www.nimh.nih.gov/health/publications/mental-health-medications/what-should-i-ask-my-doctor-if-i-am-prescribed-a-psychiatric-medication.shtml – Accessed March 27, 2013.
  • Mayo Clinic – Off-Label Drug Use Common, but Patients May not Know They’re Taking Them, Mayo Finds – http://www.mayoclinic.org/news2012-rst/7015.html – Accessed March 27, 2013.
  • Off-Label Drug Use – http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/chemotherapy/off-label-drug-use – Accessed March 27, 2013.