Should corticosteroids be declared experimental for ESI’s – and not paid for ?

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.

2 Responses

  1. Not only are the above mentioned side effects very possible but, please, if you or a loved one has Bipolar Disorder or other mood disorders it is very possible that a full blown manic/psychotic episode (event) requiring hospitalization occurs after receiving an ESI. We can be her sensitive to steroids. Even oral steroids. So, please, talk with your mental healthcare provider and have a backup plan ready in the case of a reaction. It can take a very long time to fully recover from them. So be cautious. Thank you.

  2. Yes,,,I think they should be conscider’d experimental,,or the patient should at least be warned,,steroids can doo a lot of damage..U know,,,when my medical condition was in its early stages,,15 years ago,,I got what was called back then,,a ,”tunnel catheter,” for a entire summer,,I would have to go to Milwaukee every 3 weeks for it to be changed and cleaned,,but,,at that time,,I was sent home w/3 weeks worth of screw in syringes,,,full of MEDICINE,,,NOT STEROIDS,,BUT REAL PAIN MEDICINE,,, and it still is thee only time in my life,,,that I actually got real physical pain relief at about 90%%%,,,My point is,,before this bullshit opiate phobia mess,,,real medicine was given to pain patients,,,and real medicine works..I was functioning close to my normal level,,ie less physical pain,,22 acres of fencing painted,,our entire house painted,,my little barn was emaculate,,w/more animals then I have ever had,,Nothing but complements bout how nice our place looked..It made a hug difference to be able to function in less pain because I was given real pain relief medicine..Now a days,,steroids,,,could never touch the relief real pain meds give,,thus does not allow u 2 function at acceptable levels..The switch to steroids is only because of the lies about our medicine,,They would never send anyone home now a days w/ a bag of medicine in screw in syringes,,,even though it works 100 %%%,,and allows the medically ill in physical pain 2 function at high levels.How ass backwards our field of medicine has become..Give us a steroid that damage’s the spinal cord even more,and does not improve function but for day,,,but cost the same????Again how assbackwards,,,maryw

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