What Does "Off-Label" Mean?

The term "off-label" is often used to describe certain laser or injectable treatments. It indicates the use of a medication or medical device similar to but not the same as the FDA-approved use.

For example, Botox is approved for treating frown lines between the eyebrows, but it can be used off-label for a variety of cosmetic purposes, like relaxing the muscles that can cause wrinkling around the lips.

What should raise concern is when a drug or treatment is recommended to you and the application is much different from the FDA-approved application.

For instance, injectable silicone is FDA-approved to treat corneal defects. Using the same injectable substance to enhance facial features or fill facial folds isn't just off-label-it's way off.

The idea of off-label usage can become even more confusing when you toss in the term "clinical trial." A clinical trial is technically a study to determine the safety and efficacy of a treatment, medication or device. It may include far-off-label applications of already-approved medications or devices. (Specific rules apply if you choose to participate in a clinical trial, so make sure you're fully informed before volunteering.)

Ultimately, for the best results and optimal safety with off-label treatments, you need to visit a qualified doctor who has extensive experience with treatment you choose.

What off-label treatments have you tried? Let us know by leaving a comment below.

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