FDA: Corticosteroid Injections Need Label Warning

The FDA is warning patients and healthcare professionals about the potential for rare but serious adverse events associated with injection of corticosteroids into the epidural space of the spine. These events can include loss of vision, stroke, paralysis, and death. Injections of corticosteroids into the epidural space of the spine are administered to treat neck and back pain, as well as pain that radiates in the arms and legs.

Because the safety and efficacy of epidural administration of corticosteroids have not been established and are not approved by the FDA for this use, the agency is requiring that a Warning be added to the drug labels of injectable corticosteroids. An Advisory Committee meeting of external experts will be held in late 2014 to discuss if further FDA actions are needed.

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Patients are encouraged to discuss the benefits and risks of epidural corticosteroid injections with their healthcare providers, and patients and healthcare professionals should report adverse events or side effects related to these injections to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

For more information call (888) 463-6332 or visit FDA.gov.