Blog #6: "Off-Label" uses with FDA approved drugs

This week, I decided to look into the different caveats of how FDA-approved drugs are prescribed to patients. According to the official U.S. Food and Drug Administration, the definition of “off-label” use is when FDA approval is not required, and we cannot determine with 100% accuracy whether a given administration has not been officially approved by the FDA. Although drugs go under numerous trials and rigorous clinical testing to prove their safety and effectiveness, the FDA does not evaluate unapproved uses, meaning their risks and benefits are not as certain.

This means it is not the FDA that approves the drug for use for different purposes, but the healthcare providers themselves, and although most have medical training and have a deep understanding of pharmaceutical drugs, there is usually no long-term testing for off-label uses. Healthcare providers will prescribe these drugs for different disorders because a treatment is not yet available for the specific disorder, or if the treatment is ineffective. Unfortunately, these off-label uses lack the FDA’s approval, and we are unable to determine with one hundred percent accuracy if the drug is safe for different treatments.

Through my project, I want to bring awareness to medication’s risks, the available evidence of its effectiveness, and patients should have the right to understand that the drug they are taking has not been specifically tested for the distinct disorder or health condition they might have. Most healthcare providers have a clear understanding of the side effects the medication they are prescribing has, but what they do not take into account is the cost-benefit ratio that the medication has for the patient. For example, a patient with schizophrenia has to take medication continuously because of their chronic condition, regardless of the adverse side effects the medication may have, but if a patient had an acute disorder where medication may not be required, then the adverse side effects have more of an effect. Patients should be encouraged to discuss the risks of the medication, available evidence for effectiveness in treatment, and alternative treatments with their healthcare provider.