Treatment-Resistant Disorders

The FDA approves a medication for a specific use only after a manufacturer spends years and a great deal of money proving it for that one use, so the company can market it. Importantly, the FDA regulates how drugs are marketed, not how doctors practice medicine. Once a medication is approved, physicians may — and often should — use it wherever sound evidence and clinical experience support it.

“Off-label” rarely means “unproven.” Far more often it means a use that is well established, supported by research, and prescribed every day by psychiatrists — the manufacturer simply never paid to add it to the official label. A medication approved for depression, for example, may be just as clearly effective for anxiety.

This comes up constantly in psychiatry:

• •Children and teens. Many childhood conditions have no FDA-approved medication, because pediatric studies were never funded. Using a well-established medication is frequently the standard of care, and withholding effective treatment would be the real mistake.
• •Dose. Manufacturers test conservative doses. In carefully selected, closely monitored patients, a higher dose is sometimes the right, evidence-based choice.
• •Combinations. No company studies three or four medications together, yet a thoughtful combination is often what finally gives a patient the best chance to feel meaningfully better.

None of this is experimentation. It is careful, individualized, evidence-informed medicine — guided by the research, by how leading academic centers practice, and by decades of clinical experience, always with close monitoring. Dr. Shapiro will always explain the reasoning behind a particular medication, dose, or combination and answer any questions you have.

Source: FDA — Understanding Unapproved Use of Approved Drugs “Off-Label”