FDA Not Changing Its Stance on ESIs

FDA Not Changing Its Stance on ESIs

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.

Authored by: Ed Coghlan

There are 4 comments for this article
  1. Hollie at 5:43 am

    I will never get another after finding out FDA warnings and the denial of these warnings being ignored & continued being administered by Drs!
    I am a huge advocate to alternative treatments of Therapeutic BOTOX injections for spine and spine related pain. I’ve had more success with it than everything I’ve EVER had done for pain prevention and treatment and I’ve had every procedure except a pain pump in all my 30 years of chronic pain.(I am 44) I stand by the FDA and their decision!! Good for them!!

  2. Jenn at 9:49 am

    In order for me to be seen as a “good and compliant” patient, I was “forced” to have an ESI in my cervical spine 18 months ago. That very afternoon my temp jumped to 102, my neck, face and left arm were bright red, and I was so weak I could barely walk. My white count, taken at ER, was 38,000. I was admitted to the hospital for 3 days. Contrast MRI’s and many tests later and the only explanation was a severe Allergic reaction to the injection. It didn’t even help. This is the kind of thing us chronic pain patients must endure in order to keep the medications that DO work for us. This must stop, if it is a recommendation then that is fine. But usually it is an ultimatum.

  3. Julie Bordier at 6:41 am

    This decision is terrifying. I had nothing wearing with my back until I had an Esi under fluoroscopy. It caused arachnoiditis. I made it clear to the doctor that I needed no risk, I was a young mother of three little babies, 2 with disabilities. I can’t believe my life and my family’s life were destroyed by this and there’s nothing we can do. I don’t think that doctor even remembers my name. He should be jailed and fined for the permanent damage he gave me. It took years to get a diagnosis because of all the other doctors protecting him.

  4. Marylee M. James at 7:44 am

    I wonder how many chronic pain patients are feeling as embattled and discriminated against as I am feeling now. Our physicians are not safe when they help us, we are paying the price of the war on drugs by losing our medications, and now there is total disregard on the part of too many decision makers that ESIs are, for many of us, the ONLY OPTION for reduction of pain and the opportunity to live a productive life. For the love of God do not, in some misguided fit if self righteousness, simply take this precious gift from us! We understand the risks–the risk of constant, severe pain and disability without the ESI is much higher. In fact, it is a given. The stories I have seen and heard about damage seem to reflect the lack of training of the physician, though every procedure has its risks. I also hear the complaints about the expense of the procedure. Try comparing it with the expense of home care for the disabled and increased medical care when chronic pain exacerbates every disease process in the patient, as well as causing new ones. More hospitalizations, more meds, more procedures. PLEASE fight for safer meds and procedures for ALL patients, but meanwhile, STOP TAKING AWAY THE GOOD DOCTORS, THE MEDS THAT WORK, AND THE PROCEDURES THAT WORK!! We cannot wait out our days in pain while you fight us and each other about what our physicians have done to help us.