DO NOT USE STEROID INJECTIONS FOR BACK PAIN

April 29, 2014

If you are receiving epidural (spinal) steroid injections for back pain, talk to your health care provider about switching to alternative forms of treatment.

On April 23, 2014, the Food and Drug Administration (FDA) issued a warning to users of corticosteroid injections to treat back and neck pain. Corticosteroids used for this purpose include methylprednisolone (DEPO-MEDROL), hydrocortisone (A-HYDROCORT, KENALOG), triamcinolone (ARISTOSPAN), betamethasone (CELESTONE SOLUSPAN), and dexamethasone (available in generic only). The FDA warned that these injections, made into the spine, may cause rare but serious adverse effects, including loss of vision, stroke, paralysis and death.[1]

The FDA bases this warning on a review of medical literature, as well as a sampling of cases in its Adverse Events Reporting System database. These cases showed that a number of adverse effects, including paralysis, stroke, seizures, nerve injury and death, occurred within 48 hours of a corticosteroid injection, with some occurring as soon as minutes after the injection.[2]

Corticosteroids are used to treat and prevent inflammation, and many doctors treat back and neck pain by injecting the drug into the epidural space of a patient’s spine. The FDA has not approved corticosteroids for this use, and the agency says the effectiveness and safety of this form of treatment have not been established.

Public Citizen’s Health Research Group previously cautioned against the use of steroid injections for back pain in most circumstances, as they carry safety risks and have demonstrated effectiveness only for short-term relief of nerve-related back pain in clinical trials.[3] Based on the FDA’s recent safety communication, the group now designates steroid injections as Do Not Use drugs for treating back pain, because the dubious benefits of treatment are outweighed by great potential harm from rare but serious adverse effects.

Over-the-counter remedies such as aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPRIN), ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN), and naproxen (ALEVE, ANAPROX, NAPROSYN) are often effective for short-term back pain. For long-term pain, exercise, physical therapy, and spinal manipulation from a chiropractor may provide effective relief.[4] More information on alternatives to steroid treatment for back pain is available on WorstPills.org.

If you have suffered adverse effects related to your use of a corticosteroid injection for back or neck pain, you can submit a report to the FDA’s MedWatch adverse event reporting program by downloading a form at http://www.fda.gov/MedWatch/report.htm or requesting one by phone at (800) 332-1088.

To read the FDA’s recent safety announcement, see http://www.fda.gov/downloads/Drugs/DrugSafety/UCM394286.pdf.

References

[1] Food and Drug Administration. Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems. April 23, 2014. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm. Accessed April 24, 2014.

[2] Food and Drug Administration. FDA Drug Safety Communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain. April 23, 2014. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM394286.pdf. Accessed April 24, 2014.

[3] Steroid Injections and Other Treatments for Lower Back Pain. Worst Pills, Best Pills News. November 2012. https://www.worstpills.org/member/newsletter.cfm?n_id=822. Accessed April 25, 2014.

[4] Ibid.