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- Off-Label Use: 5 Things You Need to Know
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Ever had your doctors say something is “off-label”? Chances are they weren’t talking about a pair of knockoff high heels. Using a cosmetic product off-label is a common practice but what does it actually mean? Here are the five things you need to know.#1: What does off-label mean?
Off-label applies to using a product in a way that's not advertised. For example, using Botox to treat migraines. The FDA didn’t officially sign off on that until 2010 — years after doctors first began noticing the positive side effect and began publishing the results.
#2: Off-label use is common.
Chances are good you’ve used an off-label drug and might not even know it. In fact, one in five prescriptions written in the U.S. qualify as off-label. An example? PicoSure. Originally approved for tattoo removal, the laser got the thumbs up to also treat wrinkles after clinical studies found dramatic improvements in the skin.
#3: Yes, it’s legal.
Off-label usage is legal in the U.S. and many countries around the world. What is against the law are ads that make it sound like a prescription treats a condition when the FDA hasn’t given the green light.
#4: Your doctor doesn't have to tell you.
Doctors aren’t obligated to let you when they use something off-label. In fact, they might not even know. A 2009 survey by Johns Hopkins found the majority of the 1,200 primary care physicians and psychiatrists surveyed didn’t even know common drug treatments they prescribed weren’t FDA-approved.
#5: Be informed or you might pay out of pocket — big time.
Your insurance might not cover off-label use especially for the more expensive drugs. So while the treatment may be perfectly safe, you might end up paying big. The best thing to do? Talk to your doctor.
If you have more questions on cosmetic procedures, ask thousands of doctors on RealSelf.
Off-Label Use: 5 Things You Need to Know
Ever had your doctor say something is off-label? Learn what that means for your health and your wallet. Here are the five things you need to know about off-label use.