Pharmaceutical

FDA warns of serious risks associated with epidural injections of corticosteroids

fda logo FDA warns of serious risks associated with epidural injections of corticosteroidsInjections of corticosteroids into the epidural space of the spine may cause rare but serious side effects including vision loss, stroke, paralysis and death, the Food and Drug Administration (FDA) warned. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. However, the effectiveness and safety of epidural administration of corticosteroids has not been established and the FDA has not approved corticosteroids for this use.

The agency is requiring warnings be placed on the safety labels of injectable corticosteroids to explain these risks to health care providers and patients.

While the FDA has not approved corticosteroids for epidural injection, doctors can prescribe drugs for unapproved, or off-label, uses. Epidural steroid injections have been used to treat back pain for decades but studies have failed to show long-term benefit for patients. Experts agree that more studies are needed to properly define the role of epidermal injections.

In the meantime, the FDA is working to raise awareness of the risks associated with epidural corticosteroid injections and as part of this effort, the agency convened a panel of experts, including pain management specialists, to help define the techniques for these injections which would reduce preventable harm. The expert panel’s recommendations are expected to be finalized and released by the end of the year.

The FDA will also convene an Advisory Committee meeting of external experts later this year to discuss the benefits and risks of epidural corticosteroid injections in order to determine if further actions by the agency are needed. In the interim, the FDA advises patients to discuss the benefits and risks of such procedures with their doctors, as well as benefits and risks with other possible treatments.

Any adverse events associated with epidural corticosteroid injections should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA