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Off Label Use in Medicine

Wassup Skin Ravers! How’s your week coming along? I hope ALL is going well on this beautiful September day.

Earlier this week, I was thinking about the “off label” use of drugs and devices in medicine.

So what got me thinking about this you ask?

Botox Cosmetic of course! 

If you haven’t heard, Botox Cosmetic was recently FDA approved for the temporary improvement of moderate to severe lateral canthal lines or better known to us as crow’s feet in adults. So on September 11 of this year 2013, the FDA made Botox Cosmetic the only prescription medicine allowed to treat crow’s feet. Botox Cosmetic received FDA approval for the temporary improvement of moderate to severe glabellar lines in men and women ages 65 and younger in 2002.

Did you know that physicians including dermatologists and plastic surgeons have been using Botox to treat the lateral canthal lines for many years now, just off label?

Wondering what off label use of a medication or product means??

When a medication or product is used to treat a condition it has not been FDA approved for, that is off label use.

When a medication is used in a different dosage or a different route it has been FDA approved for, that is considered off label usage.

The next time your doctor prescribes a medication or treatment for you, ask your doctor what it is FDA indicated or approved for. You may find out the prescription or treatment being prescribed is for off label use.

Does it surprise you in one study published in the Archives of Internal Medicine, researchers found, out of 725 million drug mentions, 150 million or about 21% of the drugs prescribed lacked FDA approval for the condition the doctor was treating?

I guess it’s not as surprising to me since I have seen many drugs and medical devices used in an off label manner. And no it isn’t illegal. It’s actually quite common practice and not only in Dermatology.

Radiesse is indicated for the treatment of moderate to severe facial wrinkles and folds or restoration and/ or correction of fat loss in people with HIV 
How about a non-surgical neck lift using Botox?

How about hiding some of the wrinkles and visible veins on the tops of your hands by injecting Radiesse?

Or how about filling in that divet on your cheek with some Juvederm Ultra?

Juvederm Ultra is indicated for the treatment of moderate to severe facial wrinkles such as the nasolabial folds How about silicone injections in the lip and buttocks?

I read one doctor injected Botox Cosmetic into a patient’s cheeks because he heard it could benefit rosacea.

All of the above are examples of off label usage (And all legal I might add again!).

I’m not crappin on off label usage, not at all…just that before you say yes to a treatment or prescription, learn more about it so you can weigh the associated risks if there are any.

The next time your doctor recommends Aldara cream for the warts on your hand or Botox Cosmetic for the crinkly lines on your bosom, you might want to inquire if the condition you’re getting treatment for is what the medication or product is FDA approved for (in these 2 instances, they’re not). There can be pros and cons associated but at least you will be informed and have the final say. Some people believe that doctors know everything and take their advice to heart without question (eh hmm).

Remember your health is your own responsibility and no one else’s.

Have you ever taken a medicine or experienced a treatment that was considered off label use? Please share your thoughts.

Peace out skin ravers..

I hope you have an amazing and inspiring weekend!