Do you know what “off-label” means? 83 percent of surveyed consumers say they don’t but it’s not for lack of popularity. 54 percent of plastic surgeons and 80 percent of dermatologists say they regularly work off-label (using a product or tool in a way not yet approved by the FDA). 

Sound scary? It’s not, says Denver plastic surgeon Dr. Gregory A. Buford.

“What most patients don’t realize is that many medications are used off-label simply because companies are not willing to resubmit [the medications] to the FDA to allow them to be approved for these off-label indications, but that doesn’t mean that these indications aren’t safe,” says Dr. Buford, echoing the opinion of most surveyed plastic surgeons and dermatologists.

[TWEETBLOCK text=”Tweet this”]54% of plastic surgeons and 80% of dermatologists say they regularly work off-label.[/TWEETBLOCK]

Dr. Buford points to popular facial injectables like Botox as an example of a product approved for one treatment but used safely for many others.

First OK’d by the FDA in 2002 to solely treat frown lines, Botox quickly became the go-to treatment for compliments as varied as “I’ve got migraines” to “I hate my crow’s feet.” However, it took another eight and 11 years, respectively, for those uses to be cleared by the FDA.


Chart: Do You Know What the Term Off-Label Means?


That isn’t to say there isn’t some risk with off-label medicine. While the practice itself is legal, insurance may not cover the treatment (if they’re going to cover an elective cosmetic procedure at all).

More importantly, doctors don’t legally have to say when they’re practicing off-label. That means getting all the facts is up to consumers, many of whom are under-informed about their options to begin with.

“The real issue lies less in the product and more in how it’s actually being used by the injector,” says Dr. Buford. “That’s where consumers really need to look — at the experience and expertise of who’s injecting them.”


Have a question about off-label treatments? Ask a doctor.