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FDA Not Changing Its Stance on ESIs- Pain News

FDA Not Changing Its Stance on ESIs- Pain News

Editor’s Note–Story Updated to included Terri Lewis’ quote

The FDA has decided not to modify the warning about serious neurologic events associated with epidural steroid injections. In an article published in the New England Journal of Medicine this week, it’s reported that the agency is taking a pass.

An FDA Advisory panel in November of 2014 indicated there were concerns about the safety and efficacy of injections.

Many advisory committee members expressed concern about the risk of cervical transforaminal injection of suspension glucocorticoid formulas and recommended that the FDA contraindicate suspension products for this use. Some also thought that the FDA should modify its statement to say that safety and effectiveness of the injections have not been established “by the FDA.”

To evaluate the relative use in the United States of these different glucocorticoid formulations in epidural injections, the FDA says it analyzed health care claims data from IMS Health (projected to the U.S. commercially insured population) and Medicare. More than 1.3 million epidural glucocorticoid injections were performed in approximately 426,000 Medicare patients in 2013. IMS Health data indicate that an estimated 604,000 commercially insured U.S. patients under 65 years of age received an epidural.

Critics say it is a big business. The costs per treatment vary from $600 to over $2,000.

Terri Lewis, Ph.D, who has been an outspoken critic of ESIs, was critical of the FDA non-decision.

“Today the Food and Drug Administration rejected the existing patient generated medical records that document the serious harms associated with the administration of epidural injections.  Sadly, the financial needs of a 35 billion dollar segment of the pain management industry have been placed above the needs of persons in chronic pain who cannot defend themselves from predatory practices,” she told the National Pain Report in an email.

“As the choices reduce for treatment alternatives for patients with chronic pain who are mischaracterized as addicts, we must be concerned about the impact this action will have upon individuals and families. Despite FDA’s protestations that the data they reviewed was insufficient to substantiate the relationship of epidural injections to injury and the loss of lives, the fact is that the disregard of existent patient data is not that same as evidence of lack of harms,” she added.

Advocates, however say that ESIs are useful. Dr. James Patrick Murphy of Louisville argued for them in a  story in the National Pain Report in September. One of his patients, Marylee James, wrote how they worked for her.

This is not a new issue. Consumer Reports in 2011 asked whether ESIs were “worth it”.

Four years later, the debate continues.


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