When a pain management patient is receiving treatment, most of the time it is either with an FDA cleared or FDA approved device or medicine. The interesting fact is that the indication for which that treatment or medicine may have been approved by the FDA may differ from the reason it is being given. Is this a bad thing?
There been some critics recently who have stated it is a bad thing, such as those who have come out against epidural steroid injections saying the FDA did not approve cortisone for such usage. You see, when a product or medicine goes through FDA approval, if it gets accepted the end result is approval with an indication that goes on the label.This then becomes the “On Label” indication.
Any usage otherwise is deemed an “Off label” indication. It is not an illegal use of the treatment for off label indication, rather, some of the most important advances in treatment involved off label uses of an FDA approved medication for device.
So people who use the argument against a treatment by saying that it is not an on label indication of the treatment is actually hogwash in and of itself. Let me give a classic example. Neurontin is a medication that was initially approved by the FDA for seizures. It works well for this indication and is often used for anti-seizure protocols.
However, one of the largest indications for Neurontin is to help with nerve type pain. This may be from sciatica, spinal stenosis, post-laminectomy syndrome, RSD and more. Millions of times a year, Neurontin is prescribed for these types of indications in an off label fashion.
Often what happens is a medication is being prescribed for its On Label purpose and a secondary indication becomes apparent. At times, this is accidental.
Does that automatically mean that these prescriptions are bad? Of course it doesn’t, but critics of various medications try to use that argument to sway the general public. And that is wrong, because physicians can use an FDA approved medication or treatment for any indication that is deemed to be safe and appropriate for patients. To limit the medication to only “On Label” use or to bash its usage otherwise is simply doing a disservice to patients who receive immense benefit. A lot of the times patients don’t know any better, and assume because it’s not on the FDA indication label a physician is doing something wrong. Not true at all.
Another medication that is commonly used off label is cortisone. For instance, cortisone has not been FDA approved for epidural steroid injections. However, there have been dozens of studies over the last 50 years looking at the effectiveness and safety profile of cortisone for epidural steroid injections to relieve the pain of sciatica, spinal stenosis and to help patients avoid surgery.
It is often the off label indications which are very effective, just as much as the on label variety. If you are offered a pain management treatment that is off label, that does not necessarily mean it will be ineffective or unsafe. It is typically quite the opposite. In fact, talk to your pain doctor about it. They can probably point to many well perform studies showing the effectiveness of the treatment being offered for your condition.
If you are suffering from pain that is acute or chronic, and you’re in AZ, call Arizona Pain Specialists. The pain clinics in Phoenix serve the whole Valley with 4 locations in the East Valley, West Valley, Scottsdale and Phoenix too. Treatments include medication management, interventional pain management, chiropractic, spinal decompression therapy, physical rehabilitation, and now stem cell injections.
Call (602) 507-6550 for more information and scheduling today!