FDA Requires Epidural Corticosteroid Label Changes to Warn of Potential Neurological Adverse Events

The U.S. Food and Drug Administration is requiring warning labels be added to injectable corticosteroids to describe potential serious, adverse neurological events.

Although injecting corticosteroids in the epidural space of the spine is a widespread practice to treat neck and back pain and radiating pain in the arms and legs, the FDA has not approved corticosteroids for this use, according to an FDA Safety Announcement.

In rare but serious events, this practice could result in vision loss, stroke, paralysis or death.

The FDA has also convened a panel of experts to define proper techniques for injections that would help reduce preventable harm. The panel will eventually release their recommendations.

The FDA recommends patients discuss the benefits and risks of epidural corticosteroid injections with their providers as well as benefits and risks of other possible treatments.

More Articles on Adverse Drug Events:

Direct Patient Education Improves Adherence to Drug-Use Guidelines
Reducing Adverse Drug Events at John Muir Health
Patient Safety Tool: IHI Trigger Tool for Measuring Adverse Drug Events

 

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