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.

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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.

 

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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.

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162 Responses

  1. Carla Whitehouse says:

    I had one for sciatica on both sides the right side did not do well I had excruciating pain right after could barely walk out of the Dr’s office and had to take oxycodone and a muscle relaxer as soon as i got home still did not help very much. Had a radio frequency ablation done helped some on the left side not much on the right side. i still get muscle cramps in my leg on the right side.

  2. Barbara VanGordon says:

    I wonder if this is the reason for my headaches that start at the top of my spine, and go up the back of my head. I get them when ever I am looking up or down or eating. And my vertigo and balance is so much worse.
    I had injections in my neck about where the headache starts, and they even did injections in the back of my head.

  3. Gretchen says:

    Well I’m here to tell you I had this done for years it did not help then a couple of years back the Dr kept missing up and the last time he did it to me he actually missed up bad enough it made me go in to respiratory failure and I died on them cause I stoped breathing end up in the isu will breathing tubes I tried to tell them something was going on the nurse said next time they need to give me valium so I don’t have panic attacks and then that’s when I couldn’t talk no more or move and then I went down hill could not breath so now hospital wanting to make me pay for this high price bill I won’t do it and up later having to get another stent in my heart cause cause they took me off my blood thinner to long but there is know Dr out there that will ever do this to me again and now I get to hurt all the time cause they won’t give me my pain med back cause I need to see a pain Dr I will not ever do that again so I hurt all the time I really want to a layer to get this Dr for me

    • Dale Little says:

      Your situation is why conservative management is so important. Find a really good physical therapist they may be able to help you. Here’s what to look for: Look for someone with credentials of DPT or at least a Masters level of training, next look for someone with any of these credentials: (FAAOMPT, OCS, MTC, COMT) Call them and interview them find out about there background and experience. You can look these credentials up online. There are some very sharp people out there who can help you without drugs or surgery. It’s not a quick fix so something do take time.

      • Kendra says:

        You are so right. Exercise has saved me. You must strengthen your core to get the pressure off your spine.

  4. Karen Galbreath says:

    I HAD THIS PROCEDURE AND BECAME PARALYZED. I do think people should be able to choose whether or not they want it, though, but I will be staying away for the rest of my life. I had emergency surgery which reversed my paralyzation, but I was told that if I would have waited much longer, I would’ve been paralyzed for life.

    • Dale Little says:

      There are risks to drugs and surgery! They don’t wan to tell you too much. All I can say is as a PT I have never paralyzed to killed anyone! I have made them a bit sore (early in my career) I’ve gotten better with time. I find less is best; I tell my patient’s “you can do more tomorrow – let see how you feel after today’s treatment / exercise etc. Best wishes to you.

  5. Shirley Wells says:

    My husband got these for at least 10 years or more then had a n eyebleed that nearly ruined his eyesight now is not allowed any type of steroid even on the skin

  6. Miss Aliki Jones says:

    Hi everyone, I had severe back pain for over 12 years and was given the cortisone this did not work for me but when you low in mood and in severe pain you will try things you wouldn’t normally want to have. But this did not work and the inplications are high, not to mention its not a long term solution. In the end like most people I tried several things acupuncture, oestopathic, chiropractice treatments and so much more. In the end I had a Rossiter System treatment and don’t get me wrong it was horrendously painful but I knew of no other option, so worked the treatment to my max. Guess what, it worked, no druitin patches, no injections, no pills came near. this was over 7/8 years ago. I then trained at this treatment and have helped many other, I’m so please. Again, not all treatments work for everyone but this one is well worth a try before going down this route of pain relief/or not.

  7. Michele Jansz says:

    Steroids help with inflammation but they break down bone. Now if doctors would educate their patients on the side effects that can happen years later, this conversation might not happen. How many doctors are going to the bank on these shots but NOT telling their patients about bone loss? Teeth are a form of bone to, so have you been to the dentist every 15 mins? Or did they educate on diet? Or did they ask if you had a family hx of deg. disc disease, spinal stenosis before the shots? See it helps in the immediate, but then there’s reality. See steroids and bone loss. See lupron and vision problems…Both are steroids. So, I had one bone disease, now I have 4. The resolution for doctors was to patient blame, dropping patients who reported side effects, and to flat out dump them. In order for it to treat a disease, it has to treat the disease which they do NOT do. They treat symptoms in the immediate only. It’s bs.

    • peachy100 says:

      Michele Jansz.. I agree with you completely!! It seems there are not many physicians who diagnose the CAUSE of spine pain…probably either they do not know how or they do not want to spend the time & effort to diagnose .. so they follow cookbook style trial and error and are paid very well for doing so.. My precious friend suddenly dropped dead a couple of days after being injected with 7 (seven yes) at one time in his spine..(outpatient).. He was healthy.. only health issue was spine pain!! Deaths are NOT counted, reported etc etc following ESIs in spine via outpatient …SOOOOO there is NO way to know HOW MANY deaths are caused, contributed to, or hastened by these spinal Epidural Steroid Injections!!

  8. Kendra says:

    I had severe sciatic pain in lower back and down my legs from a herniated disc. I used chiropractic medicine and work out to strengthen my core. It has truly done wonders. I rarely even have the tingling from my sciatic nerve anymore. It is hard work and I will have to exercise the rest of my life but it is so worth it to not be in pain.

  9. Your site is so fantastic. I’m going to come back here again.

  10. Linda says:

    Here’s My deal I have SEVERE Birth defects .of the Spine . Had Spinal Fusion in 95 pulled and lifted on others until I pulled3 pins lose . can’t be put back . hate Pills but also the Shots , recently took 2 shots . I also use Kratom with my Family Dr’s Ok !! Several Members of My Family use it . Read the Facts for Yourself !!All the PPL that run the Pain Clinics and Suboxone Clinics Don’t want to use it because They are getting a “Kickback ” from the Drug Companies.I know Several that use “WEED” instead of Pills . Try different things and do “Whatever “helps Your Pain.

    • Seraphim Black says:

      Linda: does Kratom work for you? I tried it once, but it just made my anxiety worse. I’ve heard if you use more, the effects become more mellow. I tried every combination of cannabis possible, but no real relief. I was just high all the time. And then the terror-anxiety would kick in sometimes. Pot may work for some, but some of us can’t tolerate it. It’s sad that big-wig doctors recommend it knowing damn well no insurance company will ever pay for it because it’s Schedule 1. Seems a bit suspicious that doctors are advocating smoking a plant instead of using modern medicine, but whatever I guess.

  11. Michele Jansz says:

    If a doctor corners you into taking the shots by saying, “Well, then you must not be in that much pain,” negates side effects, blames you for using CBD for neuropathy, it’s manipulation and then there’s a fact. It’s a matter of “informed consent” and that just freaks them out. Now comes the fun part. The pharmacies ran too. Next thing ya’ know, the medication you’ve been taking per direction for years is not “in” and they flag you. Frankly I broke out the flicker factor.

  12. Kerstin Zyla says:

    Just fabulous. Who wrote this and how can we get more?

  13. Rachel Carson says:

    I am one of the unfortunate ones who had a dangerous reaction to my epidural steroid injections… although they haven’t ‘officially’ admitted it)
    After having 3 lots of epidural steriod injections 18-20yrs ago I ended up with epidural venous thrombosis (clots in my spine) which could have killed me if they moved to my heart or lungs -they are still in the epidural cavity after 18yrs so supposedly I’m safe… I hope!!
    But it is also suspected that the epidural venous thrombosis resulted in me getting cauda equina syndrome (nerve disorder) so I have a permanent suprapubic catheter & need support walking because my legs can collapse without warning… I can only walk short distances before needing a wheelchair. Not to mention I have to take far more opiods now then I did before my epidural steroid injections when I only had prolapsed discs…

  14. Misty says:

    This makes me so sad. You are going to live in pain because of scare-mongering on the Internet.

  15. Lauri says:

    My pain specialist tried an epidural on me just a week ago. I had a cortisone shot to my hip 3 months prior with no difficulties, it helped the sciatic pain for about 6 weeks. The epidural was not a success, I was in so much pain even with the lidocaine, I told him to stop. I was getting pain and muscle cramps all down my legs. He stopped but did not pull the needle. He said let’s take a little break, about 2 minutes later the pain was back, stronger than before and I ordered him to stop. He acted like it was no more painful than a bee sting, he also looked disgusted and told me to make an appointment with my orthopedist, who sent me to the pain doctor. I had a headache for 3 days after the failed procedure. Now I’m waiting to see if he’ll do surgery on my lower back (L1-5 are involved). I’ll never try another epidural.

  16. brenda rawlins says:

    OH NO! I had one of these by AOC last December. I have very bad Degenerative Disc Disease and like a few others could not get comfortable sitting or laying down. They Orthopedic Doctor would not write an RX for pain relief since the government has banned them! I had relief one month after my injection and plan to have another one if the pain gets Horrible again!

  17. Sherry Hill says:

    I had one in the past, but found out I couldn’t take them as I am allergic to any kind of steroids. I break out into a rash & itch like crazy.

  18. Dejah says:

    I got these injections for ten solid years and they were exceptionally safe. Plus they were VERY effective for pain. I would have been crippled from nerve pain without them.

    What they did NOT warn me about was the emotional side effects from cortisone and how long they lasted.
    1) severe irritability and raginess
    2) months and months

    Eventually the shots do stop working and when that happened, the new doctor doing them sent me to a chiropractor who adjusted my back into much better function than the shots ever did. He FIXED my back. But in the perverse calculus of “health” insurance, I had to pay for that out of pocket and the chiropractor had to cut his rates so that I could afford it.

  19. Anita Leaver says:

    This is scarey to read considering after my son’s second pain management injection ….he lost 100 percent of his hearing in his left ear…coincidence or side effect????

  20. Alisha Jackson says:

    My husband has been taking these shots. It only lasts for a while then it’s back to sever pain. We’ve been to many neurosurgeons and some will do the surgery but after so many shots. Some wont do it cause ” it’s not bad enough”. If they could only see him when hes in severe pain. And they wont even give him meds that could at least give him a break in the pain. He knows the meds won’t take it away. But at least they could give him something just to dull it enough so he can function. I dont like the shots cause it seems with every shot, after it wears off the pain is worse than last time. He has 11 discs that are rather herniated or deteriorating. We’ve had multiple MRI ‘s and xrays. And they see it’s getting worse and they send him to physical therapy. ( which dosent help, he does more at home. So you tell me.

  21. Athena James says:

    I just got my first injection in my thoracic spine. I have osteoporosis and suffered 4 compression fractures when I lifted a 40 pound bag of cat litter. I cannot take narcotics, and I wouldn’t want to, besides the doctors are not wanting to prescribe them anyway. I suffered for 8 months with pain until I finally decided to try an epidural. The doctor is wonderful, she explained everything and answered all my question. The worst part of the procedure was getting up on the table in the surgery suite, the pain was awful. Once that was done, the doctor began to work her magic. The needle going in my back felt like nothing more than when they draw your blood for a lab test. She first put in a numbing agent then waited a few minutes then administered the steroids. Of course she told me I had to be perfectly still because it was a very dangerous site to be injected, and she gave me time to relax and so she could find the exact spot. The pain is so much more tolerable now, I wish I had done this sooner. She said we could repeat this in as little as 2 weeks if necessary. So I am waiting to see what will happen until I see her again with a follow up in two weeks.
    I would recommend these epidurals for pain. They are much better than swallowing opiates every day, and you won’t get relief for this kind of pain.

  22. Edward says:

    I had 4 epidural injections with in 6 months and got type 2 diabetes..that stuffs bad news

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