FDA: Epidural Steroid was Off-Label Use? Really? It Was NEVER Approved for That?

Oh I thought I can take a day off from typing up blogs but wow!!! Things come at me from friends and colleagues with the speed of light. I am outraged! So here is a new killer article for you!

Who ever in his or her mind would have thought that epidural steroid injections that many insurance companies request to be given prior to surgery were never ever FDA approved procedures?!

Oh my!! Now there is big trouble! Because they were not approved!

There is big trouble on two fronts and let me list them in order of importance where off-label use is number one!

  1. Off-label use of any drug should be illegal! We now have seen several examples where off-label use of a drug hurts people. I have written about off-label use before but let me cover it again in the quick. When the FDA approves a drug, it has extremely strict guidelines for everything, including label which must contain what it is to be used for; how it is used; each dose has a separate label; all adverse reactions must be listed. Nothing can change on this label unless the FDA says it must be changed and when the FDA says it must be changed that is bad news! There is an inconsistency in the labeling of FDA that allows an innocent appearing sentence: “your doctor may prescribe this for causes other than listed” or something similar. This is an under-the-table permit for off-label use. But this is a double-edged sword. On the one hand, the drug is not permitted to be used for anything that is not included on the label and on the other hand it permits the drug to be used for things that are not on the label. I wonder why lawyers are not yet chewing at this sentence from all angles? Is that possible they have not noticed the logical inconsistency? Lawyer? Not noticing? Nah….
  2. The steroid injections used in epidural form to be injected into the spine are now black-boxed by the following strong statement by the FDA:

Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use

Let me rephrase this making my point: Injecting corticosteroids epidural has been a widespread practice for many decades but FDA has not approved corticosteroids for such use. Wow! They have killed two birds in one swell swoop!

On the one hand they admit to allow an FDA non-approved process to happen and sort of encouraged it for decades??? For decades??? As a widespread practice? And on the other hand they have strict guidelines that will not allow a dot to be changed on the label and all drugs must be approved by the FDA prior to use?

Am I missing something here?

Will someone please tell me why we need to have the FDA? Does it have any reason to exist and oversee the safety of our drugs with such double standard? They look the other way for decades over illegal use of a procedure that ended up hurting people? Oh yeah. Let’s talk about the kind of injuries:

[04-23-2014] 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.

Oh I am tickled to tears to know that after decades of people getting hurt the FDA finally puts a new label out–not that it prevents its use even though it admits it does not show any benefit yet either: “the effectiveness and safety of the drugs for this use have not been established” so my question is dear FDA: Why are you letting a drug that is so dangerous as a result of its procedure to be continued?

Those of you who are told by your insurance companies that you should try an injectible corticosteroid epidural before other procedures, please print this article and hand it to your medical provider along with a note that the medical provider and your insurance company must sign: in case I get injured you are all responsible in court! I think you will not be forced to have that injection after all!

And if you are an attorney, please do yourself and the rest of all a huge favor and start a class action lawsuit! This is your chance!

Comments are welcomed and encouraged!!!

Angela

 

About Be Healthy

Angela A Stanton, PhD, is a Neuroeconomist who evaluates changes in behavior, chronic pain, decision-making, as a result of hormonal variations in the brain. She lives in Southern California. Her current research is focused on migraine cause, prevention and treatment without the use of medicines. As a migraineur, her discovery was helped by experimenting on herself. She found the cause of migraine to be at the ionic level, associated with disruption of the electrolyte homeostasis, resulting from genetic mutations of insulin and glucose transporters, and voltage gated sodium and calcium channel mutations. Such mutations cause major shifts in a migraine brain, unlike that of a non-migraine brain. A non-migraineur can handle electrolyte changes on autopilot. A migraineur must always be on manual guard for such changes to maintain electrolyte homeostasis. The book Fighting The Migraine Epidemic: How To Treat and Prevent Migraines Without Medicines - An Insider's View explains why we have migraines, how to prevent them and how to stay migraine (and medicine) free for life. As a result of the success of the first edition of her book and new research and findings, she is now finishing the 2nd edition. The 2nd edition is the “holy grail” of migraines, incorporating all there is to know at the moment and also some hypotheses. It includes an academic research section with suggestions for further research. The book is full of citations to authenticate the statements she makes to be followed up by those interested and to spark further research interest. While working on the 2nd edition of the book she also published academic articles: "Migraine Cause and Treatment" Mental Health in family Medicine, November 23, 2015, open access "Functional Prodrome in Migraines" Journal of Neurological Disorders, January 22, 2016, open access "Are Statistics Misleading Sodium Reduction Benefits?", Journal of Medical Diagnostic Method, February 3, 2016, open access “A Comment on Severe Headache or Migraine History Is Inversely Correlated With Dietary Sodium Intake: NHANES 1999-2004” Angela A Stanton PhD, 19 July 2016 DOI: 10.1111/head.12861 not open access, subscription is required to read it. Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in NeuroEconomics at Claremont Graduate University, and fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers. For relaxation Dr. Stanton paints and photographs. Follow her on Twitter at: @MigraineBook
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4 Responses to FDA: Epidural Steroid was Off-Label Use? Really? It Was NEVER Approved for That?

  1. Well said Angela! You took the words right out of my mouth…. Brava!

    Dennis J. Capolongo
    Director / EDNC

    Liked by 1 person

  2. working too hard says:

    Angela. off label use of drugs are more prevalent that you realize. there simply are not the dollars or manpower to study every drug to see if it is effective for every indication.

    Liked by 1 person

    • That may be true “working too hard” but given that it is a drug and drugs require FDA approval “as per label specifications” very strictly, they are illegal. The recent epidural steroid injections – you see in this article – were even required prior to any alternatives by some insurance companies and now FDA says they were not even approved. Now the FDA is complaining contradicting its own statement. Legally the FDA gets away with off-labeling by having the pharmaceuticals put on the label “your doctor may prescribe this drug for other conditions not listed” yet when this actually hurt people – as in the epidural steroids they did – The FDA points fingers immediately stating “it was not approved for that purpose.” One cannnot go both left and right at the same time neither legally nor ethically.

      Like

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