New Warning for Epidural Steroids Mandated by FDA

The U.S. Food and Drug Administration just announced that injectable corticosteroids must now contain a label warning concerning increased adverse events associated with epidural injections

Risks include death, stroke, permanent blindness, and permanent paralysis, the FDA indicated, according to MedPage Today. The warning followed an agency review of a number of reports in both the FDA Adverse Event Reporting System (FAERS) database and medical literature. In its warning, the FDA indicated that, “Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema.”

The FDA also indicated that, “Many cases were temporally associated with the corticosteroid injections, with adverse events occurring within minutes to 48 hours after the corticosteroid injections. In some cases, diagnoses of neurologic adverse events were confirmed through magnetic resonance imaging or computed tomography scan. Many patients did not recover from these reported adverse events.” The agency indicated that, while rare, the events were significant enough to warrant a change to the label.

The FDA is urging health care providers to discuss the risks and benefits of epidural corticosteroid injections with patients prior to administration, and the risks and benefits of other treatment options. Patients should also be advised that serious side effects may include neurological reactions including, loss of vision, numbness or tingling, severe headaches, or seizures.

The injections are typically used in the treatment of neck and back pain, as well as radiating arm and leg pain, and are administered in the spine’s epidural space. Corticosteroid injections are used to minimize swelling or inflammation and, while in use for decades, the efficacy and safety of these drugs for these purposes has not been established. In fact, the FDA has not approved corticosteroids for these uses.

Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

FDA’s “Safe Use Initiative” convened a panel of experts, including pain management experts, to raise awareness in the medical community of epidural corticosteroid injections and to help define the techniques for these injections, which would minimize preventable harm. Once the expert panel’s recommendations are finalized, they will be released, according to the agency.

The FDA also indicated that it will be convening an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections. That Committee will also determine if additional FDA actions are necessary.

According to the agency, this safety issue is not related to the contamination of compounded corticosteroid injection products that was reported in 2012 and associated with serious adverse reaction.