ESI and FDA approval

[MD87]

Pfizer vaccine getting FDA approval has me thinking - why is ESI not FDA approved?

I’ve read the blurb about “safety and efficacy had not being established.” Risks are so low compared to other interventions (NSAIDs?) and efficacy, at least for disc herniations causing radiculopathy, has been demonstrated. What more do we need? I don’t get it.

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[Orin]

FDA Drug Safety Communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain | FDA

[4-23-2014] The U.S. 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.

www.fda.gov

Because they're not safe. Move on to SCS.

Honestly, the controlled data the FDA wants just aren't there and the medications are not worth the cost to build FDA quality data for an indication. There was a company with a phase 3 trial working on getting a corticosteroid formulation approved for epidural usage, but no clue where it is now in the pipeline.

ClinicalTrials.gov

clinicaltrials.gov

 

[Ferrismonk]

There's no additional money to be had by getting dex/depo FDA approved for ESI.