FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

http://fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain/

The Food and Drug Administration has just issued what’s called a

 “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “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.”

 

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.

13 Responses

  1. Hello my name is Vicki Scott. I am a victim of a crime over tainted steroid injections and other many untreated issues that has lead to a terminal diagnosis. I contacted the CMS as my 2012, 2013, 2014 medical records deleted gone. 402 cases dropped. I have neoplasm in my throat and colon. Strokes, heart, lung, brain atrophy never told or treated. I was told I was being swept under the rug. Well what does that say for me as I can’t find any legal or medical help has Virginia has turned their backs on me and even the FBI told me to investigate my own criminal fraud. I reached out to the VA Attorney General Mr. Mark Herring and as I suspected nothing. So lawyers, doctors, state, federal all have me locked down. Well once I decondition all records & recordings will be on every social media platform to show how the people of the NECC couldn’t get the death penalty. Why the local, state & feds are involved. Cadden & Chin 8 years for killing many. CDC stopped taking count. I have criminal short-term-disability records that I got the treatment that others did….well I got no treatment but you will soon see who the doctor’s was that gave me treatment and reported me to the CDC as they refuse to tell me if I was reported…does it matter now? I have reached out to many lawyers & no HELP FOR ME…

  2. I understand that some dr’s now are requiring their patients to have these shots or else no meds.

  3. The first mademe lose my mind. Lost so much memory. The second one dr insisted left me with Permanente anxiety. STILL IN F#@&!ING PAIN.Stopped going to drs…deal with pain myself. CVS WALGREENS all can go go to hell. Now hope they all have pain every day!!!

  4. Then why do doctors still have them done and why don’t they warn you about complications that might happen

  5. The only time I let steroids in my body is for Asthma and muscle lock ups. Freaking bone dissolving Crap. And forget the big pack of prednisone, at the end of the 7 day I am fighting mad

  6. Interesting, especially when FDA Had medications which benefited people with Chronic Conditions for years which mysteriously disappeared w/o warning or notice, only to Reappear after 12 (first-time) returns to the pharmacy and after incurring 4 medically related doctor visits which
    revealed synthetic Arsenic poisoning, and is still not addressed, hasn’t done Anything at all to remedy this. I have written several local and state politicians, recently senator Gillibrand, which I never received an acknowledgement. I wasted my time, and continue to today. I am literally Sick over our predatory dysfunctional broken System. They don’t work for us, they work for the corporations that own them. I Wish I Was An Addict, because then I could heal by just going through withdrawals. However, I am also very aware of serious abuses that are being done to all of us that isn’t disclosed publicly but will be soon.

  7. Thank you Steve for posting this! I will indeed be shoving this in my no caring Dr.’s face!

    • I always wonder if neither the FDA nor the company that first marketed this med (UpJOHN) supports this med being administered in this methodology. Should docs who have been doing this procedure (ESI) be considered guilty of insurance fraud ? Using a FDA approved off label is generally considered permissible but this application is using the med in a different route of administration than is approved and that may not “Fly” under the “off label” exemption.

      • I don’t know when it first appeared, but I read a few articles saying the makers of the particular steroid clearly stated that they were NOT to be used for ESIs. It seems to me that they should be going after the doctors that are using the stuff wrong, not the makers.

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