Houston Methodist. Leading Medicine

Neck FAQ

Question:

What does off-label use mean? My surgeon was telling me about using bone substitute for my spinal fusion and had me sign a paper saying I know it is an off-label use. At the time I thought I understood it, but when I tried to explain it to my brother, I got all fouled up.

Answer:

Off-label use means the drug, implant, procedure, or device is not being used for what it was originally intended or tested for. The practice is not illegal -- doctors who discover a drug that works well for one application may see many other potential uses. But without proper testing for safety, the Food and Drug Administration cannot approve that drug for a secondary or off-label use. The high cost of research and development for products like this is prohibitive for most companies to launch another off-shoot series of studies for a product they already know works well for the first application. So the pharmceutical companies cannot advertise their products for off-label uses (that WOULD be illegal). They depend on physicians doing some practical hands-on research to help support other uses for their medications. In the case of bone substitute, products like INFUSE, a bone morphogenetic protein (BMP) has gained quite a foothold in the world of spinal fusions. Surgeons found that this product hurries the body up in forming new bone cells at the surgical site. The fusion quickly stabilizes the spine with its ability to induce rapid bone growth. At first it was just designed and tested for lumbar (low back) spinal fusions. But it worked so well, surgeons started trying it in other parts of the spine (thoracic or midback and cervical or neck). Placing the bone substitute anywhere but in the lumbar spine is considered off-label use. There have been some problems in patients who received BMPs for cervical spine fusion done from an anterior approach. Unexpected swelling of the throat with difficulty swallowing and speaking was one of thos complications. Compression of the airway and cutting off the air was another even more serious (life-threatening) problem. Off-label use of medications can be perfectly safe but without adequate testing, there's an increased risk that something might go wrong. No doubt your surgeon explained all of this to you. That's what the paper you signed was for -- to make sure you know what the risks and potential complications of an off-label use of bone substitute could be. If you are still in doubt, don't hesitate to call the surgeon's office and ask for a copy of the paper you signed. Review it again and make sure you know what it is you are agreeing to. Your surgeon will be willing to answer any further questions you have. Don't hesitate to ask for more information until you feel comfortable that you know what is going to happen and be able to explain it to someone else. Unrestrained Spread of New Technology Leads to Rash of Serious Complications in Neck Surgery. In The BACK Letter. August 2009. Vol. 24. No. 8. Pp. 1, 90, 92.

*Disclaimer:* The information contained herein is compiled from a variety of sources. It may not be complete or timely. It does not cover all diseases, physical conditions, ailments or treatments. The information should NOT be used in place of visit with your healthcare provider, nor should you disregard the advice of your health care provider because of any information you read in this topic.
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