Blog — Notes of a Plastic Surgeon

Welcome to my blog. I am a plastic surgeon in Seattle and have been in private practice since 1991. I've seen more than a few interesting faces and cases through my years spent in the exam room, the operating room and the emergency room. And I have an opinion on just about everything relating to plastic surgery (and a lot of unrelated stuff). If you like my blog, let me know. Thanks for reading! Lisa

What does off-label use mean???

What do you mean it’s not FDA approved?

Seattle Plastic Surgeon explains off-lable use.

Today I had this question from a prospective patient.   Off-label use means exactly what it says – something is being used off label.   The label in off-label is the label or insert included in a medication or device that describes the product and its FDA approved use(s).  It is not at all unusual for medications or devices to be used in a situation that is not FDA approved. 

Here are a couple of examples.  Retin-A was initially approved as a treatment for acne.  Retin-A was also found to reverse some signs of skin aging and it was used for years as an anti-aging cream until the FDA finally approved Retin-A for that particular use.  Botox is another example.  It is approved to treat wrinkles between the eyebrows (the glabellar wrinkles) but it is also used for other facial wrinkles, crowsfeet for example.   HA fillers such as Restylane, Juvederm, Prevelle and others are approved for specific areas of facial creases like the nasolabial fold that runs from the side of the nose to the mouth.  But the HA fillers are also used for other areas that need some volume, for example the tear trough which the groove under the lower eyelid that can make some people look sad and/or tired. 

Off-label just means that the FDA has not approved a particular drug, substance or device for a certain area, for a certain indication, in a certain dose or for a certain population group.  It does not mean that the physician using something off-label is working on his or her Frankenstein monster in the back room.  And off-label use is perfectly legal.  The FDA cannot dictate how doctors practice medicine.  The FDA does forbid the manufacturers of drugs and devices from advertising their products for off-label use or promoting such use to physicians.

Soooooo….fear not and trust me. I’m a doctor.

Thanks for reading!  Dr. Lisa Lynn Sowder

 

Category: Government and Politics, Plastic Surgery | Tags: , , , , ,

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