Thursday, April 24, 2014 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.