Understanding the difference between “off-label” and “contra-indicated”

August 6, 2013 by
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Terms used frequently in medical conversation can easily be misunderstood by the average person. Two of these commonly confused terms are “off-label” and “contra-indicated.”

Let’s start with “off-label.” What does it mean? Does it mean something is illegal? Used in the wrong way? Something that has gone bad like outdated food or medicines?ASDS Blog

“Off-label is none of these. It’s simply a term that means a drug or device is being used in a way that was not part of its FDA clinical approval. Nearly all soft-tissue fillers are studied as to their behavior and safety when injected in the nasolabial folds (more commonly known as “smile lines” or “laugh lines”). However, most soft-tissue fillers are used in many areas of the face, not just in the nasolabial folds. All those other areas are “off-label” uses.

Neuromodulators (Botox, Dysport and Xeomin), for instance, are often used in the upper face, mid-face, lower face and sometimes the neck. Any area beyond the upper face is “off-label.”

Most physicians will use both neuromodulators and fillers in locations that were not included in the FDA studies. To restrict them to studied areas would only serve to seriously limit the cosmetic changes people are looking to achieve.

Is “off-label” use safe? It’s possible for anyone to experience an adverse reaction to injectables, but very seldom is a product used in a way that can cause serious issues. If there are reasonable risks of potential problems, that use becomes “contra-indicated.”

“Contra-indicated” has an entirely different meaning. It means there is specific direction by the manufacturer NOT to use a product in a certain way or under certain conditions. Some filler products are known to create problems when injected into the lips. Since those problems are recognized, physicians are told they are “contra-indicated” and should not be used in a particular area.

Neuromodulators are not injected in women who are pregnant or breast feeding – that is a “contra-indication” as there is a possible safety issue, no matter how slight. But injection of that same neurotoxin to lift the sagging mouth corners of a woman who is neither breast feeding nor pregnant is simply considered “off-label.”

How can you tell if something is “off-label?” A physician must inform a patient if any injectable is being used “off-label.” And, of course, any patient request for a procedure that is “contra-indicated” is refused.

Common “off-label” procedures include: fillers for lip augmentation (an exception is Restylane that has FDA approval for lip injection), fillers for cheek or chin augmentation, neuromodulators anywhere other than frown lines or crow’s feet and fillers for hands to hide protruding veins.

Cosmetic dermatology is a rapidly growing and changing field. There is a constant flow of new products and technologies in the pipeline along with ongoing collaborative studies of already approved technologies and products.

Dermatologists and surgeons routinely share with one another new ways of using those products and technologies, and they also share the problems they encounter that were unexpected. In this way, the benefits can be widely enjoyed and the cautions can engender an even higher level of safety and satisfaction for the patient.

About

Nissan Pilest, MD, is a board-certified dermatologist in Orange County, Calif. He is an active Associate Professor of Dermatology at the University of California. Dr. Pilest heads a busy cosmetic and medical private practice, Total Dermatology, in Irvine, Calif. He is a trainer for Fraxel and Candela lasers as well as a trainer and speaker for Allergan and Merz. Visit his website at: http://www.totaldermatology.com

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