ROCKVILLE, Md -- April 23, 2014 -- The US Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.
The FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and the FDA has not approved corticosteroids for such use.
The FDA reviewed a sampling of cases from the FDA Adverse Event Reporting System (FAERS) database, as well as cases in the medical literature of serious neurologic adverse events associated with epidural corticosteroid injections. Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain oedema. 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.
Additional Information for Healthcare Professionals
• Rare but serious neurologic adverse events have been reported with epidural corticosteroid injections, including spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, and death.
• These serious neurologic events have been reported with and without the use of fluoroscopy.
• Discuss with patients the benefits and risks of epidural corticosteroid injections and other possible treatments.
• Counsel patients to seek emergency medical attention immediately if they experience symptoms after receiving an epidural corticosteroid injection, such as loss of vision or vision changes; tingling in their arms or legs; sudden weakness or numbness in their face, arm, or leg on one or both sides of the body; dizziness; severe headache; or seizures.
• Report adverse effects following epidural corticosteroid injections to the FDA MedWatch program: https://www.accessdata.fda.gov/scripts/medwatch/
To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized.
As part of the FDA’s ongoing effort to investigate this issue, they plan to convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.
Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. This safety issue is unrelated to the contamination of compounded corticosteroid injection products reported in 2012.
SOURCE: US Food and Drug Administration