Off-Label Use of Cosmetic Injectables
In any discussion of cosmetic injectables (such as Botox or dermal fillers), the term “off-label use” is often heard. In fact, the use of these substances in a manner that is considered “off-label” is in some cases more common than the approved use.
What Does "Off-Label" Mean?
So what exactly does it mean when we say that a particular use of a product or drug is “off-label”? To understand the answer, we must first understand the role of the U.S. Food and Drug Administration (FDA).
The FDA's role in helping to ensure consumer safety is to test foods, drugs, and medical devices and then subsequently approve them (or not) to be marketed for stated uses. When the FDA approves a cosmetic injectable, it is for a specific purpose (like the treatment of fine wrinkles) in a specific location on the body (like the brow). When an approved product is used in a different location, or for a purpose not described in the FDA's official approval of the product, such use is considered to be "off-label.
When it comes to cosmetic injectables, the FDA approves the use of products to be used in a specified manner in a particular area of the body or face. When a product is then used in a different area of the body or face, or for a purpose not described in the FDA’s official approval of the product, such use is considered to be “off-label.”
How (and Why) Does Off-Label Use Happen?
Although FDA approval is specific as to a drug’s intended use, it exerts very little control over use by physicians once the product is on the market. For the most part, doctors are bound only by their own ethics, common sense, and concern for their patients in deciding how to best prescribe, use, and/or administer a given drug or device.
Where the FDA does exert control is in the marketing and promotion of FDA-approved products. Technically, they may only be marketed for their approved purposes. But when an off-label use is even marginally successful, word does get around.
In fact, most people don’t realize that Botox Cosmetic is approved only for injection into the forehead, to treat the glabellar lines that run vertically between the brows. This means that injection of Botox into any other part of the face (i.e., to the sides of the eyes to treat crows’ feet) is an off-label use.
Another great example is a long-lasting dermal filler called Sculptra, which was first approved only for the treatment of loss of facial fat in HIV-positive individuals. Doctors saw its potential for results in the cosmetic injectable arena, and used Sculptra off-label for some time as a dermal filler. Sculptra subsequently won FDA approval for cosmetic use in August of 2009.
Is Off-Label Use Dangerous?
Off-label use can be dangerous in the wrong hands. When a particular use is not approved, it is also not regulated. Therefore, there is a greater risk of improper use. When a product is used off-label, that often means that there is a shortage of true scientific data backing up its safety and effectiveness.
Many physicians (and drug companies) will argue, though, that even approved use can be dangerous when done by an unqualified or inexperienced practitioner. They believe that the ability to incorporate off-label uses into their treatments means better results and an opportunity to present a wider variety of options to meet their patients’ differing needs. In fact, in the case of cosmetic injectables like Botox, anecdotal evidence (in the form of literally millions of satisfied patients) seems to suggest that off-label uses of some substances can be quite effective and safe in the right hands.
Why Not Just Get Approval?
Though new uses may be added to an FDA-approved drug's label through a process called a supplemental new drug application, this does not occur often, due mainly to economics. Clinical trials are costly, and it is possible that the conclusions of the trial may not sufficiently support a use that is already widely in practice. This makes seeking supplemental approval a risky business decision for the product’s manufacturer.
Unfortunately, this means exactly what it sounds like. Without enough evidence of safety and effectiveness, you are in effect taking your chances. However, statistics indicate that many find it to be an acceptable risk.
How Does Off-Label Use Affect Me?
Simply put, a well-informed patient can expect better results. Find out whether your injectable is approved for the type of procedure you want. If the answer is no, ask your doctor how many times he or she has used it for your intended purpose, and what complications (if any) have arisen. Ask the doctor for references from other patients who have had the same procedure using the same injectable, and follow up with those patients to find out if they were satisfied with their results. Look at before and after photos of patients who’ve undergone the procedure.
The most important thing is to be sure you only receive injections from a fully qualified and licensed physician, in a proper medical setting. In-home parties, beauty salons, and high-end hotels are not appropriate setting for cosmetic injections.
Of course, it is always your risk to take (or not), whether or not the procedure you’re considering is considered off label. Even if you have done your homework, asked the right questions, and chosen the right surgeon, you still may not feel comfortable with the uncertainty of an off-label injection. Don’t let anyone talk you into doing a procedure in which you do not have confidence. When in doubt, do without.
Sources:
Allergan Approval Letter, U.S. Food and Drug Administration; April 12, 2002
Regulating Off-Label Drug Use — Rethinking the Role of the FDA; Randall S. Stafford, M.D., Ph.D.; New England Journal of Medicine, Volume 358:1427-1429, Number 14
Sculptra Approved for Cosmetic Use, Press Release, Physicians Coalition for Injectable Safety, August 13, 2009
