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    FDA Issues Warning on Common Off-Label Neck, Back Pain Treatment

    The US Food and Drug Administration (FDA) has issued a warning (.pdf) about the dangers of administering epidural injections of corticosteroids to relieve neck and back pain. According to the FDA, the off-label use could result in blindness, stroke, paralysis, and death.

    The potential problems were characterized by the FDA as "rare but serious" for a treatment whose effectiveness "has not been established." The injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. Epidural injections of corticosteroids to treat neck and back pain, as well as radiating pain in the arms and legs, have been a "widespread practice for many decades," according to the FDA.

    Although many of the reported problems occurred within 48 hours after the injection and were temporary, some patients never recovered. The FDA is advising patients who receive the injections to be on the lookout for changes to vision, tingling in the arms and legs, dizziness, seizures, severe headaches, or sudden weakness or numbness in face, arms, or legs, or on one or both sides of the body.

    The FDA recommends that patients "discuss the benefits and risks of [the injections] with your health care professional, along with the benefits and risks associated with other possible treatments."

    APTA has a long history of involvement in the development of information and resources on neck and back pain. Some of the resources available to physical therapists (PTs) include a MoveForwardPT.com webpage on low back pain, the PT's Guide to Osteoarthritis, clinical practice guidelines on low back pain (.pdf) and hip osteoarthritis (.pdf), and a Learning Center presentation on manipulation for low back pain. PTNow provides full-text access to the latest clinical practice guidelines and Cochrane systematic reviews related to low back pain and neck pain.  


    Comments

    I received 2 injections in my mid/lower back because I was told that we had to do this step before having nerves burnt. I have had these shots in my back before and they have never helped and the nerves being burnt lasted almost 2 years. It has been almost 3 weeks now and the pain is about 5 times worse than before I had the shots, but the Dr. said I HAD to have the shots first before he would burn the nerves. Also something about the insurance required this step first, even though it doesn't help me. I start a new job in 2 days that is physically demanding and would be able to endure the mild pain, but since the shots any physical labor is very pain intensive. I have been dealing with the chronic pain in lower back due to a bulging disc for about 8 years and have never had this much pain.
    Posted by john hedrich on 4/26/2014 7:21 PM
    The reason you are getting such poor results is that early researchers have made fatal errors in research in biomechanics, structure, testing, and measurement resulting in errors in diagnosis and treatment. I have described these and more on my website and invite you to visit at www.thelowback.com How it works, why it hurts and how to fix it. Be well. Richard DonTigny, PT
    Posted by Richard DonTigny, PT on 4/27/2014 11:00 PM
    Why do WE (Americans,medical professionals, patients, politicians) allow the insurance companies to have so much power? No one but YOU should have the power to decide what goes into your body. Not in a specific pre-described order. And of course the drug companies allowing this mismanagement of injectibles should be taken to the cleaners in court. But they won't. I really don't understand why the MDs, PTs, RNs, patients are not banding together to fight the system in Washington DC. This is where these companies are buying our freedoms which are sold to the highest bidder.
    Posted by Christina Frohlich PT DPT OCS on 4/29/2014 12:18 AM
    There is growing evidence epidural injections don't help but still practiced because of profit. Treating back pain with injections is like turning off the tornado siren off during tornado warning.
    Posted by Rico L. Paras, PT on 4/30/2014 12:16 PM
    Pills and injections are considered to be high risk.. I don't understand why anyone has them anymore.
    Posted by William O'Toole on 5/1/2014 7:18 PM
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