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FDA Warns Epidural Corticosteroid Injections for Back, Neck Pain May Result in Rare but Serious Adverse Events


Many people who have pain in the back or neck, as well as pain radiating into the legs or arms, are treated with injectable corticosteroids. Injected into the epidural space of the spine, the injections are done to reduce swelling and inflammation, and, ultimately, temporarily relieve pain or discomfort.


But the U.S. Food and Drug Administration (FDA) released a warning April 23, 2014, that these injections can result in serious complications, including loss of vision, stroke, paralysis and death. These serious neurologic events have been reported with and without the use of fluoroscopy. Health care providers use fluoroscopy to see inside the body when they’re delivering the injections.

Patients should know about these risks and weigh the risks and benefits associated with epidural corticosteroid injections with their physicians, as well as explore other treatment options, according to the FDA.

While injecting corticosteroids into the spine has been a widespread and popular practice for decades, researchers have yet to establish the effectiveness and safety of the drugs used in this way. In fact, the FDA has not approved corticosteroids for epidural injections to treat back, neck, arm or leg pain. And it was concerned medical professionals who prompted the FDA to investigate the matter.

The FDA brought together a panel of medical experts, including pain management experts, to help describe best practices, or ways in which medical professionals giving these injections could reduce the risks. But these recommendations have not yet been released.

In the meantime, patients and doctors should be aware of the risks and report any adverse events that occur. Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

Patients should seek emergency medical attention if they experience any unusual symptoms after receiving an epidural corticosteroid injection. These include:

loss of vision or vision changes

tingling in the arms or legs

sudden weakness or numbness of the face, arm, or leg on one or both sides of the body

dizziness

severe headache

seizures.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
•Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
•Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Physical therapists are trained to help people suffering with back, neck, arm and leg pain, tingling or numbness with noninvasive, nonsurgical therapy options. Physical therapy also focuses on restoring mobility, function, flexibility and strength, as well as preventing future bouts of back and neck pain. For more information about what a physical therapist can do for you, contact A Physical Therapist, Inc.

A Physical Therapist, Inc., is a one-on-one physical therapy clinic in Delray Beach, Fla., and Harrisburg, Penn. For patients in Palm Beach County, A Physical Therapist, Inc., is easily accessible from Boca Raton or Boynton Beach. For patients in Dauphin County, A Physical Therapist, Inc., is easily accessible from Hershey and Marysville.

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